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FAQs: CEP Dihydrotachysterol & Cholesterol HP

FAQs regarding the revisement of CEP Cholesterol HP of CARBOGEN AMCIS

Regulatory affairs

  • What kind of inspection has been performed?

    Our CMO DISHMAN CARBOGEN AMCIS Ltd voluntarily requested for an inspection as the last one was already 5 years ago. Therefore the current outcome was certainly not expected by our Indian colleagues.
  • We are not MAH, what do you expect from us?

    Please inform your customer(s) who do hold MAs.
  • When is the revised CEP available?

    We do expect the revised CEP, without the Indian production location within the next two weeks, depending on further restrictions due to the COVID-19 outbreak. As soon as the revised certificate is available your RA contact will be informed.
  • Will the Open Part of the DMF be updated?

    As the current Open Part of the DMF is a combined one a separate Open Part for Minakem material will be prepared. Due to the uncertain situation (a.o. Covid-19 virus) we target to have this completed by the end of April.
  • What are the consequences for the US DMF #25382?

    It is hard to predict how FDA will look at EDQM’s and Swissmedic’s report. EDQM will inform all relevant authorities on the outcome, it is up to them to take action(s). A summarized report on the inspection will become available on EUDRAGMP.
  • Are any other CEPs involved?

    Besides the CEP for Cholesterol HP there is one in the name of Carbogen Amcis B.V. which will be suspended (Dihydrotachysterol), the other CEPs on our name remain valid.
  • Are there other qualified suppliers?

    On the CEP of Cholesterol HP also Minakem, France is registered as manufacturer. Also we are preparing plans to add one or two other manufacturers on the CEP.
  • What do I have to do as MAH?

    As MAH you are responsible with regard to the substance concerned and any related marketing authorisation or marketing authorisation application. We will help you as much as possible, for instance with the risk assesment. Therefor we created a document in which we have related the findings to the product. This will help you with the risk assessment. You can find this document below.

    Download

  • Is the last FDA inspection report available?

    Yes, it is available. You down download this document below.

    Download

  • Will the site Bavla be registered again on the CEP as a production location for Cholesterol HP?

    No, we are currently investigating other options.

Quality assurance

  • Are there any BST/TSE issues for Cholesterol HP?

    No, the product is guaranteed manufactured from New Zealand or Australian wool grease and no other animal derived products are manufactured in Unit 6, the unit where Cholesterol HP is manufactured.
  • Is this a recall?

    This is not a recall, but we advise you strongly not to use the product. Since there is no valid CEP, you cannot use the Cholesterol HP in your drug product if you make reference to the CEP in your registration files.

    In the end, the MAH has the final decision.

  • What is the reason for removal of the CEP?

    The CEP is not removed. The manufacturing site of DISHMAN CARBOGEN AMCIS Ltd is removed from the CEP, locations of Carbogen Amcis B.V. (intermediates) and Minakem (final steps) will remain on the CEP.
  • Can we get a copy of the report?

    Yes, you can download the copy below.

    Download

  • Were observation made specifically related to Cholesterol HP manufacture?

    No, Unit 6, where Cholesterol HP is manufactured, was not mentioned in the report. However some general observations will also influence Unit 6 such as the handling of recovered solvents and cleaning.
  • Has any purity or adulteration of cholesterol HP been identified?

    No, not specifically. However some general observations will also influence unit 6 such as the handling of recovered solvents and cleaning.
  • Was the lack of Quality oversight related to the CEP and TSE/BSE?

    Overall outcome is non-GMP (critical!), therefore it is related to HP as well.
  • How is the removal of DISHMAN CARBOGEN AMCIS Ltd from the CEP for TSE/BSE related to lack of Quality oversight and GMP issues?

    This is not explicit explained in the report.
  • What is the timeline for Corrective Actions and being recertified?

    We are in close contact with DISHMAN CARBOGEN AMCIS Ltd. They are primarily responsible for the CAPA plan to be sent to the EDQM. We are involved in drawing up the CAPA plan.

    We expect the submission of a CAPA plan within 3 weeks.

    After submitting and executing the CAPA plan, a re-inspection of the EQDM is necessary in order to qualify for lifting the removal of the site. Given the current developments with COVID-19, it is very uncertain what the timelines can be.

  • Can CGAM B.V. do an analysis on BSE/TSE in Cholesterol HP?

    No, but that is not necessary either. The purchase of wool grease and the starting material is done by CGAM BV. This can guarantee that the wool grease is BSE / TSE free. We can demonstrate the traceability.

  • Is the production method of Cholesterol HP at Minakem (also at the CEP) the same as At DCGAM Bavla?

    Yes, you can download the copy of the declaration on Equivalency Cholesterol HP below.

    Download

FAQs regarding the suspension of CEP Dihydrotachysterol of CARBOGEN AMCIS

Regulatory affairs

  • What kind of inspection has been performed?

    Our CMO DISHMAN CARBOGEN AMCIS Ltd voluntarily requested for an inspection as the last one was already 5 years ago. Therefore, the current outcome was certainly not expected by our Indian colleagues.
  • We are not MAH, what do you expect from us?

    Please inform your customer(s) who do hold MAs.
  • How long will the suspension take?

    We are in close contact with DISHMAN CARBOGEN AMCIS Ltd. They are primarily responsible for the CAPA plan to be sent to the EDQM. We are involved in drawing up the CAPA plan.

    We expect the submission of a CAPA plan within 3 weeks.

    After submitting and executing the CAPA plan, a re-inspection of the EQDM is necessary in order to qualify for lifting the suspension of the CEP. Given the current developments with COVID-19, it is very uncertain what the timelines can be.

  • Are any other CEPs involved?

    The other CEPs in the name of Carbogen Amcis B.V. remain valid, except for the Cholesterol HP which will be revised (deletion of one of the production locations).

  • What do I have to do as MAH?

    As MAH you are responsible with regard to the substance concerned and any related marketing authorisation or marketing authorisation application.

    We will help you as much as possible, for instance with the risk assessment. Therefore we created a document in which we have related the findings to the product. This will help you with the risk assessment. You can find this document below.

    Download

  • Is the last FDA inspection report available?

    Yes, it is available. You down download this document below.

    Download

Quality assurance

  • Is this a recall?

    This is not a recall, but we advise you strongly not to use the product. Since there is no valid CEP, you cannot use the Dihydrotachysterol in your drug product if you make reference to the CEP in your registration files.

    In the end, the MAH has the final decision.

  • What is the timeline for Corrective Actions and being recertified?

    We are in close contact with DISHMAN CARBOGEN AMCIS Ltd. They are primarily responsible for the CAPA plan to be sent to the EDQM. We are involved in drawing up the CAPA plan.

    We expect the submission of a CAPA plan within 3 weeks.

    After submitting and executing the CAPA plan, a re-inspection of the EQDM is necessary in order to qualify for lifting the suspension of the CEP. Given the current developments with COVID-19, it is very uncertain what the timelines can be.

  • Can we get a copy of the report?

    Yes, you can download the copy below.

    Download

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Careers

Bring Your Future to Life

We are a global employer with eight sites all around the world. As a part of CARBOGEN AMCIS you will work in an international network and a family-like atmosphere and profit from the amenities of a global employer.

Your work will contribute to our company’s success while building your career, developing your knowledge further and writing your personal success story. As a global employer we offer a great variety of working fields in different departments.

Your workplace & opportunities

When you start working for CARBOGEN AMCIS, you begin life in a new multicultural and international family. As an international company with 8 sites around the globe we operate in a dynamic work environment.
Discover what it is like to work for CARBOGEN AMCIS.

Meet your future colleagues

Explore our different departments and meet our dedicated people who are the core of our company.

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Working as a service provider in the pharmaceutical industry involves a wide range of different departments and offers diverse employment possibilities across all our sites in chemistry but also administrative and enabling services.
Want to join us and bring your future to life?

Apprenticeship

Turn your passion for Chemistry into a real hands-on experience and bring your future to life! An apprenticeship opens the door for you to the pharmaceutical industry and can lead your professional path to a full-time position with CARBOGEN AMCIS. Learn more about our apprenticeship program as a Lab Technician.

For more information
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News

Latest news from CARBOGEN AMCIS

Below, you will find the latest news from CARBOGEN AMCIS, the Dishman Group and the industry as a whole.  Please do not hesitate to contact us if you would like further information on any of the items below.

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Crystallization

Decide on the best crystalline form of your API with the support of CARBOGEN AMCIS' crystallization experts

Defining the best crystalline form of an API is crucial in drug development, since it has a significant impact on the effectiveness of the formulation and, therefore, the bioavailability of the finished dosage form. CARBOGEN AMCIS has established a capability that supports our customers with crystallization investigations, including solubility tests, salt screening, and optimization of the crystallization process and the solid-liquid separation in the API isolation process. Polymorphism screening complements the service portfolio.

We offer online monitoring of critical parameters such as particle size, turbidity, temperature, and pH value. We also provide analytical services, dedicated to solid phase characterization; including hot-stage microscopy, differential scanning calorimetry and X-ray powder diffraction.

Our Crystallization Capabilities

  • Salt screening and salt selection
  • Polymorphism screening
  • Solubility and crystallization screening; optimization of crystallization processes
  • Small-scale up with MSZW or solubility curves
  • Identification of critical parameters for scale-up, definition of filtration and drying parameters, polymorph control
  • Isolation of amorphous solids via spinodal degradation, spray-drying and lyophilisation
  • Online monitoring of particle size and turbidity
  • Solid-state characterization (DVS, XRPD-DSC, water activity, DSC, TGA, hot stage)
  • Pre-formulation support

For more information about our analytical capabilities to support crystallization development, click on the link below to download the brochure or contact us today.

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Services

Services for Active Pharmaceutical Ingredients (APIs) & Drug Products (DP)

CARBOGEN AMCIS provides services for the development and manufacture of APIs as well as drug products applying state-of-the-art containment technologies.

Our flexible approach enables customers to benefit from tailored packages which balance their needs in terms of speed, cost and quality.

Clinical API Development

With more than 30 years of experience in API development we can support our customers with their project at any stage throughout all clinical phases.

Commercialization Services

Our service portfolio includes a wide range of fully integrated support functions that guide our customers through the life cycle of their drug substance, from development to commercial manufacturing. Our teams of experts plan the right strategy for you and manage your project along the full process to a commercial status.

Drug Products

We offer a complete range of drug product development and manufacturing services. Our speciality is the injectables and the handling of complex compounds such as highly potent API, biological products and drug delivery. Learn more about our drug product services at our site in Riom, France.

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General Conditions of Purchase

General Terms and Conditions of Purchase of Material

These General Terms and Conditions of Purchase (the “Terms”) shall exclusively govern and apply to the purchase of materials, such as products, chemicals, intermediates, substances, articles, items, machinery or equipment, etc. (the “Goods”) by CARBOGEN AMCIS HOLDING AG or - as the case may be - any of its Subsidiaries and Affiliates (the “Buyer”) from any seller (the “Seller”; Buyer and Seller also each a “Party” or collectively the “Parties”). For the purpose of the Terms an “Affiliate” shall mean any company that directly or indirectly controls, is controlled by or under common control with the Buyer, where “control” shall mean the power, direct or indirect, to direct or cause the direction of the management and policies of such entity, whether by contract, through the ownership of a significant percentage of the shares, or through the by-laws or otherwise.

No terms and conditions contained in any document issued by the Seller shall be binding on Buyer, even if they have not been expressly rejected by Buyer. Seller acknowledges selling Goods solely on these Terms which take precedence over Seller’s different or additional terms and conditions. Neither Buyer’s receipt nor acceptance of delivery shall constitute acceptance of Seller’s different or additional terms and conditions. Buyer’s failure to object to provisions contained in any document from Seller shall not be construed as waiver of the Terms or an acceptance of any such provision.

In case of any discrepancies between the provisions of the Terms with any other documents (including the Order acknowledgement), the Terms shall take precedence over all and any such documents; provided, however, that Agreement (as defined below) does not expressly modify, amend or supersede a specific Section of the Terms with the express reference to such Section being modified, amended or superseded. The quality or technical agreement (if any) shall take precedence in all matters regarding the standard of quality of the Goods.

1. Purchase Orders

1.1. Buyer’s purchase order (the “Order”) shall become a binding agreement between the Parties (the “Agreement”; of which these Terms form an integral part of) upon Seller’s acknowledging acceptance thereof in writing. Failure to return the written Order acknowledgement within ten (10) days from the issuance of the Order shall entitle Buyer to immediately cancel the Order without any liability whatsoever. Any provision on Seller’s Order acknowledgement that modifies or contradicts the Terms shall be deemed null and void.

1.2. Any (additional) agreements, obligations or commitments not being made in writing shall be deemed null and void until confirmed in writing by Buyer.

2. Purchase Price; Taxes; Payment

2.1. The purchase price for the Goods (the “Price”) stated in the Order, is binding and not subject to any revision or adjustment and shall be inclusive of packaging and crating and shall be the sole compensation to which Seller shall be entitled to for the performance of the Agreement.

2.2. Except for VAT (if any), the Price shall include all taxes and duties of every kind.

2.3. Invoices shall be issued immediately after dispatch of the Goods to the address stated in the Order and indicate the number of the Order. Statutory VAT (if any) shall be separately shown on the invoice.
2.4. Payment terms are thirty (30) days from receipt of a correct and undisputed invoice.

2.5. Buyer shall have the right to withhold payment in case of delivery of Non-Compliant Goods (as defined below) until such Goods are replaced with conforming Goods. Furthermore, Buyer shall have the right to offset any claim against Seller against payments due to it.

3. Subcontracting; Assignment

3.1. Seller shall be fully responsible and liable for its own suppliers and sub-contractors.

3.2. Seller shall not assign this Agreement, in whole or in part, to any third party without the prior written consent of the Buyer.

4. Delivery Dates

4.1. Delivery dates and delivery location stated in the Order are binding and time is of the essence. Seller undertakes to immediately inform Buyer if it appears that it will not be able to adhere to the delivery dates and set out the earliest possible delivery date, both in writing. Delivery to another location than stated in the Order is deemed to be a non-delivery.

4.2. Upon the express request of Buyer, Seller shall enable partial deliveries.

4.3. If the delivery dates or delivery locations are not adhered to by Seller, then Buyer shall be entitled to immediately and without setting a grace period (i) terminate the Agreement or cancel the delivery and purchase of any outstanding Goods; (ii) return for full credit and at Seller’s expense any such delayed or wrongly delivered Goods; (iii) procure replacement Goods from a third party, in which case Seller shall compensate any reasonable additional costs and price differences for the Goods; or (iv) claim all damages, losses, costs, expenses, etc. arising from the delay or wrong delivery. The remedies in this Section 4.3 are cumulative and in addition to any remedies, which Buyer may have at law, in equity or otherwise.

5. Package; Shipment

5.1. If not expressly agreed otherwise in the Agreement, all Goods shall be delivered DDP (Delivered Duty Paid) as defined by Incoterms 2010 to the delivery location stated in the Agreement.

5.2. All Goods to be supplied hereunder shall be packed, marked, labelled and otherwise fit for shipment and accompanied by all paperwork and documentation (e.g. Certificate of Analysis) in a manner which is in compliance with good commercial practice and with all laws applicable for the transportation, handling and import of such Goods. All packaging material used for the transportation of the Goods shall be non-returnable. Delivery not accompanied by all necessary paperwork and documentation shall be deemed to be a non-delivery of the Goods.

5.3. Seller shall comply with Buyer’s standard routing and shipping instructions (including import guidelines).

6. Transfer of Title, Risk and Ownership

Transfer of ownership of the Goods and full title to it as well as the risk of loss, liability or damage to Buyer occurs upon full delivery of the Goods at the delivery location stated in the Agreement.

7. Specifications; Quality; Safety

7.1. Goods shall meet the specifications and quality standards as agreed in the Agreement and be fit for intended use and free from defects in workmanship and materials. If no specifications or no certain standard of quality are determined in the Agreement, the Goods shall be of appropriate quality to be expected from a first-class provider of such Goods under the circumstances.

7.2. Seller shall observe all relevant legal requirements in relation to health, safety and environment, and in particular marking of hazardous Goods. Seller shall provide to Buyer, prior to the first delivery, Seller’s current material safety data sheet and other literature pertaining to hazards associated to the Goods and the precautions, which should be observed. Seller shall promptly provide to Buyer any revisions thereto.

7.3. If not defined in the Agreement, the responsibilities related to quality systems, quality requirements, quality control, testing and manufacturing records, audits, complaints, inspections and release of Goods shall be governed by a separate quality or technical agreement.

7.4. If Seller, its employees or subcontractors, are present at Buyer’s premises, they shall always observe Buyer’s safety instructions and comply with all safety and security policies and other arrangements applicable at such premises.

8. Non-Compliant Goods; Rejection of Goods

8.1. Any Goods delivered to Buyer shall be subject to Buyer’s inspection. Such inspection or failure to inspect shall not relieve Seller of any of its representations, warranties or liability hereunder.

8.2. Any complaints by Buyer to Seller regarding any quantitative or qualitative deviations of the Goods from the Agreement, any non-conformance to the representations and warranties of Seller or any defects (any of the before a “Non-Compliance” or “Non-Compliant Goods”) shall be made in writing not later than ten (10) business days from the time Buyer discovers the relevant Non-Compliance, however in no event later than (i) within two (2) years after the date of delivery, or (ii) the expiry of the shelf life of the Goods (if any); whatever is shorter. Buyer may return to the Seller for full credit and at Seller’s expense any Non-Compliant Goods.

8.3. At Buyer’s sole discretion Seller shall within thirty (30) days after receipt of the notice of complaint at its cost either (i) rework or reprocess the Non-Compliant Goods into conforming Goods, (ii) replace the Non-Compliant Goods with conforming Goods, or (iii) promptly refund to Buyer (or at Buyer’s sole discretion to credit) any payment received with respect to such Non-Compliant Goods. Sub-Section (iii) shall also be applicable if Seller is unable to rework, reprocess or replace Non-Compliant Goods into/with conforming Goods within the timeline.

8.4. If Seller disputes the claim of Non-Compliance from Buyer, the Parties shall investigate all reports of Non-Compliance with the intent of overcoming such Non-Compliance. The Parties shall act promptly and shall cooperate fully in such investigations. If the Parties do not reach an agreement, then they shall (each acting reasonably and in good faith) mutually elect an independent third party being an expert in the field of dispute, e.g. a laboratory (acting as an expert and not an arbitrator) to determine if the Goods are Non-Compliant Goods and make a determination regarding the cause of the Non-Compliance. Such results shall be binding upon both Parties. The cost of the testing and evaluation by the expert shall be borne by the Party being wrong.

8.5. For any reworked, reprocessed or replaced Goods the provisions of this Section 8 shall be applicable.

8.6. Payment or use of the Goods shall not constitute acceptance thereof and shall not prejudice any and all rights and claims that Buyer may have against Seller. Any signature of a representative of Buyer on any shipping or receiving document shall not constitute acceptance of the Goods or any different terms or conditions, or acknowledge condition of the Goods, but shall merely acknowledge receipt thereof.

8.7. The remedies in this Section 8 are cumulative and in addition to any remedies, which Buyer may have at law, in equity or otherwise.

9. Seller’s Representations and Warranties

9.1. Seller represents and warrants to Buyer

  1. that the Goods are of good quality, in conformance in every respect with the Agreement (including the agreed specifications), fit for intended use and purpose and free from any defects;
  2. that it has manufactured, labelled, marked, registered, sold, shipped, exported, imported, delivered and invoiced the Goods in compliance with all applicable laws, statutes, ordinances, regulations, rules and orders of any governmental authority;
  3. that neither it nor any of its employees or subcontractors engaged in the performance of the Agreement has been debarred or is subject to debarment or to any restrictions or sanctions by the FDA or any other governmental or regulatory authority or professional body with respect to the performance of the Agreement;
  4. full title to all delivered Goods, which shall be free and clear of any and all liens, restrictions, securing interests, encumbrances and third party interests;
  5. that the Goods and its possession or intended use by the Buyer or its customers shall not infringe any valid intellectual property rights of any third party; and
  6. that the Seller has all rights (including intellectual property rights) licence, permits, approvals and authorisations required to manufacture, use, sell, export and deliver the Goods and to preform its obligations under the Agreement.

9.2. The representations and warranties in this Section 9.1 are continuing and in addition to any warranties implied by law with respect to the Goods.

10. Indemnity and insurance

10.1. Seller shall indemnify and hold harmless Buyer (including their respective employees, directors and authorised representatives) arising or resulting from any and all claims, suits, actions, demands, damages, settlements, losses, liabilities and costs (including reasonable attorneys’ and legal fees) whatsoever made against, suffered or incurred by the Buyer arising from or relating to or in connection with Buyer’s (its officers’, agents’, employees’, successors’, subcontractors’ or assigns’) purchase, possession, use, sale or transfer of the Goods, or by reason of Seller's (its officers’, agents’, employees’, successors’, subcontractors’, assigns’ or Affiliates’) breach of warranty, representation or Agreement however caused.

10.2. Seller shall take adequate insurance polices to cover any liability under this Agreement.

11. Confidentiality; Publication

11.1. Subject to Section 11.2, neither Party shall disclose to any third party (a) any information (of whatever kind and in whatever form or medium) disclosed by or on behalf of the owner (the “Disclosing Party”) to the other Party or its designee (the “Receiving Party”), identified as confidential or reasonably understood to be so, whether prior to or during the term of the Agreement and whether provided orally or visually and thereafter condensed in writing within twenty (20) days, electronically, or in writing; (b) all copies of the information described in (a) above; and (c) the existence and each provision of the Agreement (together the “Confidential Information”) for a period of ten (10) years from the date of disclosure. Each Party agrees to use and utilise Confidential Information solely for the performance of the Agreement and to treat the Disclosing Party’s Confidential Information with the same degree of care as it uses for its own confidential information at least using reasonable care. Each Party agrees to limit its internal dissemination of Confidential Information to only those employees, officers, authorised agents, affiliates and subcontractors who have a need to know the Confidential Information for the performance of the Agreement and who are contractually bound by restrictions of disclosure and use at least as onerous as those in this Section 11.

11.2. Confidential Information falling within one of the following exceptions shall not be subject to the restrictions of Section 11.1: (a) to the extent permitted by the Disclosing Party’s written consent;(b) to the extent Receiving Party can prove that Confidential Information is public knowledge or, after disclosure hereunder, becomes public knowledge through no fault of the Receiving Party; (c) to the extent Confidential Information can be shown by Receiving Party to have been in Receiving Party’s possession or control prior to the date of disclosure hereunder; (d) to the extent Receiving Party can establish that Confidential Information was received from any third party, which, by Receiving Party’s reasonable judgment, did not breach any restrictions of disclosure; (e) to the extent Receiving Party can establish that the Confidential Information was independently developed by itself without reference to Disclosing Party’s Confidential Information; or (f) to the extent Receiving Party can establish that it is required by law, regulation, subpoena, judgment, order or other similar form of process to disclose Confidential Information to a government, other public authority or third party, provided however that Receiving Party immediately upon learning of such obligation, and prior to disclosure, if lawfully possible, notifies Disclosing Party of such disclosure obligation and reasonably cooperates with Disclosing Party in limiting the scope of disclosure, if lawfully possible.

11.3. In addition to the foregoing, Buyer shall have the right to disclose such parts of Seller’s Confidential Information as far as needed to register its or its customers’ products containing Goods with any regulatory agency having authority in the field of drug supervision, regulation and enforcement (e.g. FDA).

11.4. If Receiving Party becomes aware of any unauthorised use, disclosure, access, possession or knowledge of Disclosing Party’s Confidential Information, it shall immediately notify Disclosing Party and take all reasonable steps requested by Disclosing Party to protect the confidentiality of such Confidential Information.

11.5. At Disclosing Party’s request, Receiving Party shall return or destroy all Confidential Information of Disclosing Party. However, Receiving Party may retain one copy of all such Confidential Information in its legal records for the purposes of ensuring compliance with the Agreement and Receiving Party may keep such copies that may have been generated by automatic back-up systems.

11.6. Neither Party shall publish or permit to be published either alone or in conjunction with any other person any information, article, photograph, illustration or any other material of whatever kind relating to this Agreement, or the other Party’s business generally, or make any use of the other Party’s trade marks or logos, without prior approval in writing from such Party. Such approval shall apply to each specific application and relate only to that application.

12. Force majeure

12.1. Neither Party shall be held liable for any failure in performance of any part of the Agreement or any breach of contract resulting from force majeure events beyond its control, including but not limited to fire, flood, explosion, war, embargo, acts of God, terrorism, riots or similar causes. If a Party is affected by an event of force majeure, it will forthwith notify the other Party of the nature and extent of such force majeure event and the Parties will enter into bona fide discussions with a view to alleviating its effects and to agreeing such alternative arrangements as may be fair, reasonable and practicable. The Party affected by a force majeure event is under obligation to give full particulars thereof and to use its best efforts to minimize the effect of occurrence and to take the necessary remedial measures.

12.2. If as a result of force majeure events, performance of the Agreement, in whole or material parts thereof, is suspended for more than thirty (30) days in any single twelve (12) month period, either Party shall have the right to terminate the Agreement by giving written notice to that effect to the other Party.

13. Notices

13.1. Any official notice required shall be in writing signed by duly authorised representative of the respective Party and shall specifically refer to this Agreement. Notices shall be sent via one of the following means and will be effective: (a) on the date of delivery, if delivered and handed over in person; (b) if sent by email (with delivery confirmed) (i) on the date of receipt, provided, however, the email was received by recipient on a business day at his domicile between 00.00 and 17.00 his time zone; (ii) the next business day following receipt, if the email was received by recipient outside a business day at his domicile or between 17.00 and 24.00 his time zone; or (c) 72 (seventy two) hours after postage, if sent by private express courier or by first class certified mail, return receipt requested. Any notice sent via email shall be followed as soon as reasonably possible by an original of such notice by private express courier or by first class mail.

13.2. The provisions of this Section 13 shall not be applicable for the day-to-day communication between the Parties.

14. General provisions

14.1. No course of dealing or failure of either Party to strictly enforce any term, right or condition shall be construed as a waiver of that term, right or condition.

14.2. Should one of the provisions of the Agreement or of any additional stipulations agreed upon be or become invalid, the validity of the remaining conditions and stipulations shall not be affected thereby. Parties shall use their best endeavours to replace the invalid provisions with a valid provision with respect to the same subject matter.

14.3. This Agreement (together with the quality agreement; if any) constitutes the entire agreement and understandings (oral and written) between the Parties relating to the subject matter hereof and supersede all previous oral and written communications between the Parties with respect hereof.

14.4. No modification, alteration or amendment to the Agreement shall be of any force or effect unless done in writing with the express reference to the Sections of this Agreement being modified, altered or amended and signed by duly authorised representative of both Parties.

14.5. The Parties hereto are independent contractors and nothing contained in this Agreement shall be deemed or construed to create a partnership, joint venture, employment, franchise, agency or fiduciary relationship between the Parties.

14.6. The headings are for convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of this Agreement. Unless the context otherwise clearly requires or otherwise specified, whenever used in this Agreement: (a) the word “including” and words of similar import shall mean “including, without limitation”; (b) the words “hereof,” “herein,” “hereby” and derivative or similar words refer to this Agreement; (c) whenever the word “or” is used in this Agreement, it shall not be deemed to be exclusive; (d) all references to the word “will” are interchangeable with the word “shall” and shall be understood to be imperative or mandatory in nature; and (e) all words used in this Agreement shall be construed to be of such gender or number, as the circumstances require.

15. Termination

15.1. The Agreement may be immediately terminated by either Party if (i) the other Party is in material breach of this Agreement and such material breach is not capable of remedy or not remedied within (30) thirty business days after it has occurred; (ii) insolvency or liquidation proceedings are commenced by or against the other Party; or (iii) the other Party becomes bankrupt or otherwise incapable of paying its bills as they fall due or if a receiver or administrator in bankruptcy has been appointed to run such Party’s affairs.

15.2. Buyer shall be entitled at any time and from time to time to terminate the Agreement or to cancel the delivery and purchase of any outstanding Goods for no cause by giving written notice to Seller.

15.3. Termination or expiry of the Agreement shall not affect the accrued rights, remedies, obligations or liabilities of the Parties existing at termination or expiry, nor shall it affect the coming into force or the continuance of any provision of this Agreement which is expressly or by implication intended to come into force or continue in force on or after termination or expiry.

16. Applicable law, Jurisdiction

16.1. This Agreement shall be construed, interpreted, governed and enforced exclusively in accordance with the substantive Swiss law except as for its conflict of law rules, which would refer to another applicable law. The application of the Convention of the United Nations of April 11, 1980 on Contract for the International Sale of Goods is hereby expressly excluded.

16.2. The Parties shall try to resolve any disputes arising out of or in connection with this Agreement amicably through good faith negotiations. In the event that such attempts should fail within thirty (30) business days from the first negotiation, the dispute shall be exclusively and finally resolved by the Civil-Court of Basel-Stadt, Switzerland (“Zivilgericht Basel-Stadt”). This shall not limit the right to appeal in Switzerland.

CARBOGEN (word), AMCIS (word), CARBOGEN AMCIS (word) and AC (logo) are trademarks owned or licensed by CARBOGEN AMCIS HOLDING AG and all rights are reserved.

Version 02
Bubendorf, 27 April 2020

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Open Positions

Start your career at CARBOGEN AMCIS

When you start working for CARBOGEN AMCIS, you begin life in a new family. Our employees are the very core of our unique and extraordinary client offering and, as such, we value each and every member of our exemplary staff base.

Below you will find our latest employment opportunities across our international bases and within a variety of disciplinary departments. Simply use the drop down filters to narrow down by location, department or employment basis. Check back regularly, in order to ensure you don't miss out on any of our latest vacancies in your area!  

RELATED TOPICS

GLOBAL LOCATIONS

LIFE AT CARBOGEN AMCIS

APPRENTICESHIPS

OUR PEOPLE

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Highly Potent API

Four levels of Protection Cascade ensure worker safety and product quality

CARBOGEN AMCIS has state of the art facilities and controls to handle both drug substance and drug product of the highest potency and toxicity, under cGMP.

Our dedicated containment facilities use a containment methodology, utilizing barrier isolation technology and Rapid Transfer Ports (RTPs), combined with pressure cascades, airlocks and access controls.

Our service portfolio starts from laboratory-scale (for process research and development purposes) up to large-scale manufacturing, in 1,600 liter vessels. These capabilities are underpinned with dedicated analytical and preparative purification technologies.

Highly Potent API Production at CARBOGEN AMCIS

I have been working for CARBOGEN AMCIS for over 10 years and there are still new challenges to tackle each day which makes the role very interesting.

Stefan - Production Supervisor, Bubendorf

Safety & Product Quality

There is nothing more important to CARBOGEN AMCIS than the safety of our workers and patients. As they are the key to our business - the design of our facilities, cleaning and hygiene concepts are built with this as our guiding principle.

  • Years

    More than

    15

    years

    experience in development & manufacture of HiPo APIs

  • Compounds

    Capability to handle up to category

    4

    +

    compounds (< 0.05 µg/m³)

  • HiPo

    More than

    40

    %

    are HiPo projects

  • HiPoC

    Up to

    20

    cm

    for HiPo Chromatography kit available

For more information
download our Company Profile
brochure or contact us today.

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Products

High Quality Products from our site in The Netherlands

Besides clinical development and commercialization of API and the services for drug products, CARBOGEN AMCIS also offers high quality Cholesterol and Vitamin D analog products.

Manufactured at our facilities in Veenendaal, The Netherlands, these products are used in a variety of markets all around the globe.

Vitamin D Analogs & D2

Our site in Veenendaal, The Netherlands, has more than 70 years of experience in manufacturing, marketing/sales and distribution of Vitamin D analogs and Vitamin D2 (Ergocalciferol). We ship our products worldwide. Find out more about our products and additional services.

Cholesterol & Lanolin Derivatives

A wide range of Cholesterol products and Lanolin Alcohols/derivatives is produced at our site in Veenendaal, The Netherlands and distributed worldwide to our customers.

For more information
download our Cholesterol and Vitamin D Analogs 
brochure or contact us today.

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Under maintenance

All good things need a little upkeep!

We are currently updating our website with new functionality and information. We expect to be back online within a couple of hours, so please check back soon!

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Bubendorf

Directions

By public transport

  • Take the train from Basel, Zurich or Olten to Liestal
  • From Liestal take bus no. 70 “Reigoldswil Dorfplatz” to Bubendorf, Industrie Süd
  • Once you reach Bubendorf, Industrie Süd it will arrive right in front of the entrance to our headquarters

By car (from Zurich)

  • Get on A1H from Sihlquai, Hardturmstrasse and Route 1
  • Take A1/A3 and E60 to Route 12 in Liestal. Take the exit toward Solothurn/Waldenburg from A22
  • Follow Route 12 to Hauptstrasse in Bubendorf

By car (from Basel)

  • Get on A3 from St. Johanns-Vorstadt and Elsässerstrasse
  • Follow A3 and A22 to Route 12 in Liestal. Take the exit toward Solothurn/Waldenburg from A22
  • Follow Route 12 to Hauptstrasse in Bubendorf

By car (from Bern)

  • Get on A6 from Kirchenfeldbrücke, Thunstrasse and Ostring/Route 6
  • Take A1/E25 to Höchacher in Diegten. Take exit 12-Diegten from A2/E25/E35
  • Continue on Höchacher. Take Bennwilerstrasse and Route 12 to Hauptstrasse in Bubendorf

Apprenticeships

About the apprenticeship program

We offer 3-year apprenticeship programs as a Lab Technician. The apprenticeship starts in the beginning of August and can be completed at our sites in Aarau, Neuland or Bubendorf. Be sure to check our Open Positions page to apply! We look forward to receiving your application.

Location: Can be completed in Aarau, Neuland or Bubendorf
Duration: 3 years

Apprenticeship Programs

  • 1 day a week: professional education in Aarau
  • ½ day a week: general knowledge and sports
  • 1 day a week: professional education in Aarau
  • 1 day a week and every second Saturday: general subjects for vocational matura in Lenzburg
  • Assignment of instructor
  • 3 or 3 ½ days a week in the company
  • Practical work including assistance with a variety of projects
  • 1 hour theory/homework each week
  • Regular exams

It's motivating working for a company that supports and encourages each individual to continuously grow professionally. I have been able to gain valuable industrial work experience through the apprenticeship at CARBOGEN AMCIS whilst undertaking a degree simultaneously.

Kurt - Laboratory Technician, Manchester

  • Innovative and global company which combines world-class chemistry skills to provide seamless drug substance, drug product development and commercialization services for leading pharmaceutical and biotechnology companies.
  • Our vision is to help customers create a better world as the partner of choice for development and niche scale manufacturing of complex and challenging substances, highly potent active ingredients and drug products.
  • You will be working alongside excellent scientists contributing to research helping to develop the next generation of medicines.
  • You will draw strength from a highly collaborative and intellectually stimulating environment.
  • Take on responsibility in a supportive, dynamic environment and gain valuable technical as well as transferable skills in your chosen field as a Lab Technician.
  • Work alongside our scientists to help solve important problems. All apprentices will have a mentor throughout the program to support, coach and guide them on their journey.
  • Opportunity to network and socialise with like-minded people in an international environment.
  • Great environment to continue to practice and keep improving your professional skills.
  • Opportunity to be better prepared for your future professional life.
  • Someone who has a passion for science and is highly driven
  • Fluent in German as well as a good command of spoken and written English
  • Highly motivated team player, who is reliable as well as goal-oriented
  • Sekundarschule or Bezirks school
  • Good grades in mathematics and the natural sciences
  • No prior work experience needed

To learn more about the apprenticeship programs and our application process please contact us.

What can you expect from the program?

August to December:
Internal introductory course

April:
Analytic and synthesis practical (3 to 4 weeks each)

*Including practical courses in February (3 weeks) and September (3 weeks)

September:
Internal intermediate examination (practical and theoretical about the first year.

October:
Analytical internship 

April:
Synthesis course 

*Including practical courses

September:
Internal intermediate examination (practical and theoretical about the second year.

January to April:
Exam preparation

May:
Practical exam (2 days)

Early June:
Theoretical examination (4 days)

Download the brochure
for tips on how to make the
most out of your apprenticeship or contact us today.

Download Brochure

Download (German)

Contact Us

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LIFE AT CARBOGEN AMCIS

ABOUT US

OPEN POSITIONS

GLOBAL LOCATIONS

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Specialities

Integrated Services from a Single Source

CARBOGEN AMCIS exists to provide innovative solutions for drug development and supply to the pharmaceutical and bio-pharmaceutical industries that enable customers to bring new generation medicines to market.

We have built up a portfolio of specialist services to give our customers the highest degree of flexibility possible.

Highly Potent API

CARBOGEN AMCIS has more than 15 years of experience in the development and manufacture of highly potent Active Pharmaceutical Ingredients (API) up to category 4+ (<0.05 µg/m³). More than 40% of our projects are highly potent projects.

ADC & Bioconjugation

We can manage tailored ADC & Bioconjugation projects - from drug linker synthesis to final drug product. CARBOGEN AMCIS’ state-of-the-art clean room suite is fully cGMP qualified. Our dedicated team of experts will advise you on the best linker and conjugation strategy.

Chromatography

Our very experienced chromatography experts guide you through a vast range of in-house solutions to tailor an optimal program around your needs.

Crystallization

Having established our crystallization capabilities we can support our customers with a variety of services such as polymorphism screening, solubility tests, salt screening and optimization of the crystallization process.

Stability Studies & Integrated Analytical Services

As a part of our service portfolio our stability studies offering can be tailored according to our customers’ needs and provides a thorough understanding of the chemical behavior that supports assessing drug storage, shipment conditions, expiration dates and packaging.

Flow Chemistry

During your process you might face challenges with scale-up, hazardous reagents or fast reactions. CARBOGEN AMCIS’ experience in Flow Chemistry will help you handle the risks and increase safety.

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Cholesterol & Lanolin Derivatives

From natural resource to high-end products

CARBOGEN AMCIS B.V. offers a wide range of Cholesterol products as well as Lanolin Alcohols/derivatives. These high quality products are produced at our Veenendaal site in The Netherlands. Production, but also sales and worldwide distribution to our customers is exclusively managed from this site.

  • Cholesterol HP

    Application:
    Cholesterol HP is a cGMP Cholesterol grade used mainly in liposomal formulations. It enables controlled release by encapsulation of drugs/actives in injectables and it can be used as a carrier for diagnostic substances.

    Specification:
    Cholesterol HP is a white crystalline powder
    Cholesterol (GC), 99.0 - 101.0%
    Total sterol (GC), ≥ 99.5%

    CAS: 57-88-5

    Download Product Sheet

  • Cholesterol NF

    Application:
    Cholesterol NF is used as an emulsifying agent in cosmetic preparations as Cholesterol functions as an excellent moisturizer in skin conditioning cosmetics. Besides this Cholesterol NF is also used as starting material for Vitamin D3 production as well as technical applications such as liquid crystals.

    Specification:
    Cholesterol (GC), ≥ 95%
    Total sterol (GC), ≥ 99%
    A-tocopherol, 50-350ppm (anti-oxidant)

    CAS: 57-88-5

    Download Product Sheet

  • Cholesterol SF

    Application:
    Cholesterol SF is a feed grade Cholesterol mainly used in Shrimp feed/premixes. Cholesterol is an essential molecule for the synthesis of molting hormones, sex hormones, bile acids, vitamin D and is a building block of shrimp tissues. Cholesterol cannot be metabolized by shrimp and is therefore added to shrimp feed. It improves the yield in many ways; survival, FCR and growth.

    Specification:
    Cholesterol (GC), ≥ 91%
    Total sterol (GC), ≥ 97%
    A-tocopherol, ≥ 50ppm (anti-oxidant)

    CAS: 57-88-5

    Download Product Sheet
  • Cholesterol XG

    Application:
    Cholesterol XG is a feed grade Cholesterol mainly used in Shrimp feed/premixes. Cholesterol is an essential molecule for the synthesis of molting hormones, sex hormones, bile acids, vitamin D and is a building block of shrimp tissues. Cholesterol cannot be metabolized by shrimp and is therefore added to shrimp feed. It improves the yield in many ways; survival, FCR and growth.

    Specification:
    Cholesterol (GC), ≥ 80%
    Total sterol (GC), typical 85%
    A-tocopherol, ≥ 50ppm (anti-oxidant)

    CAS: 57-88-5

    Download Product Sheet
  • Lanolin Alcohol Dusoran

    Application:
    Dusoran is a cosmetic grade of Lanolin Alcohol ideal for use in hair colourants, hair conditioners, hair treatment (relaxing and perming), 2 in 1 hair combination products etc. In skincare applications, Dusoran can be used in both facial and body care.

    Specification:
    Saponification value (mgKOH/g): ≤ 10
    Acid value (mgKOH/g): ≤ 5
    Color (Gardner) 22.5 g/100 ml: ≤ 10
    Cholesterol (GC): 8 - 13%
    Dropping point: 50 - 80°C
    Melt behaviour: clear melt at 90 °C

    CAS: 8027-33-6

    Download Product Sheet
  • Lanolin Alcohol technical

    We offer a variety of downstream Lanolin Alcohol products. All low Cholesterol content and mainly used in technical applications such as leather care. For more information on these products and specifications please contact us.

    CAS: 8027-33-6

  • Lanolin Fatty Acids

    For more information on our Fatty Acids and its specifications please contact us.

    CAS: 68424-43-1

  • Years

    More than

    70

    years

    of experience

  • Kilogrammes

    Production from mg to several

    100

    metric

    tons

  • Products

    Products distributed across

    65

    +

    countries

For more information
download our Company Profile
brochure or contact us today.

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Stability Studies

ICH Stability Studies and Integrated Analytical Services

Through many years of experience being the API development partner of choice, CARBOGEN AMCIS has a deep and wide understanding of the critical need to perform stability studies as well as forced degradation studies to support drug development.

We have the experience and capability to assess drug storage or shipment conditions, expiration date, and packaging. These studies provide a thorough understanding of the chemical behavior, degradation pathways and the intrinsic stability of a new molecule.

Stability studies are part of a large number of different projects; the possibility of performing analytical work with different molecules and the discovery of their features is a very interesting part of my work.

Katja - Chemist QC&A, Neuland

Integrated Analytical Services

Our stability studies are performed in fully cGMP validated and mapped stability chambers, which operate at ICH conditions (25°C/60% RH, 30°C/65% RH, 30°C/75% RH and 40°C/75% RH) and at low temperatures (5°C, -20°C and -80°C). Our forced degradation studies encompass stress testing under acid or alkaline conditions, oxidative stress testing and photostability studies. Based on the innovator’s specific needs, we can develop and tailor stability studies, as well as forced degradation tests, at any stage of the drug development.

For more information
download our ICH Stability Studies & Integrated Analytical Services
brochure or contact us today.

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Life at CARBOGEN AMCIS

We are a family

Our employees are central to the offering of CARBOGEN AMCIS and, as such, we endeavor to make the working environment, company culture and organizational values second to none.

Offering a truly diverse working environment across all of our international locations underpins the global offering we supply to the healthcare market.  Our employee benefits and flexible working arrangements not only help us reward our employees, but help us attract vast talent bases and ongoing dedication to the company and its clients.

Darja - QC&A

What I enjoy most is the daily interaction with people, being in a position to help others, the diversity of tasks and the family-like environment. It's motivating to know I can make a significant contribution to the success of the company.

Manuela - Senior Human Resources Assistant, Bubendorf

  • Culture & values

    • The supportive environment and the 'people' oriented culture at CARBOGEN AMCIS makes it a special place to work.
    • We are driven by our vision to help our customers create a better world as the partner of choice for development and niche scale manufacturing of complex and challenging substances, highly potent active ingredients and drug products.
    • Our growth is dependent on building strong and long lasting relationships with our customers.
  • What it's like to work here

    • Being a part of CARBOGEN AMCIS means being a part of a company that makes a difference to global health.
    • We offer diversified and attractive job positions across our 8 sites around the world.
    • By joining CARBOGEN AMCIS, you will integrate with a multicultural and international team which creates an exciting and dynamic workplace.
  • Diversity & inclusion

    • We celebrate diversity – of culture, of background, of experience and thought – and recognize it as a key to our ability to deliver high quality services.
    • As a global business our people come from all over the world. You will draw strength from a highly collaborative and intellectually stimulating environment.
  • Employee benefits

    At CARBOGEN AMCIS we recognize the involvement and the dedicated work of our employees. Our success can only be achieved through the efforts of a talented and committed workforce, as such we place a high value on our people and their contributions.

    We offer a range of employee benefits catered specifically to the location. Any employee, working from our sites in Switzerland, France, UK, The Netherlands or China will be offered a tailored list of benefits according to the different country needs and regulations

    In addition, we offer travel insurance to all our employees worldwide, not only for business trips but for private journeys also, to protect you as well as the person/s you're travelling with from the financial impact of unforeseen circumstances. We are also committed to providing an inclusive and rewarding work environment that acknowledges the efforts of outstanding and long-term employees.

    Take a look at Our People to find out more about what makes CARBOGEN AMCIS such a great place to work.

Working at CARBOGEN AMCIS

Why deciding upon a career with us may be the best decision you’ve ever made so far, and then it gets even better.
  • Presence

    A global presence with

    7

    sites

    in Switzerland, UK, France, Netherlands & China

  • Nationalities

    More than

    24

    nationalities

    in the company

  • Age

    Average age

    41

    years

    old

  • Team

    We are

    1

    united

    and multicultural team

CARBOGEN AMCIS Career brochure

For more information
download our Career brochure
or contact us today.

Download Brochure (English)

Download Brochure (German)

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Enabling Services

The Pillars of Success

Our enabling services are the support of our customized individual packages for our customers allowing us to provide the highest quality while ensuring full safety and authority compliance.

At CARBOGEN AMCIS we have experienced teams that are dedicated to the project success. Our experts are fully committed to managing our customer’s projects and maintaining the highest quality standards – from the first proposal to the delivery of the product.

Quality Management

Quality is crucial at CARBOGEN AMCIS. We are fully committed to the safety of patients. Our long and successful audit history proves our high quality standards.

Regulatory Affairs

Our highly experienced team consults through the complex regulatory process and provides support and guidance to develop the best regulatory strategy for our customers.

Project Management

A strong project management is key to project success. The collaboration between departments, internal and external communication require dedicated managers to handle challenges and meet goals.

Environment, Safety & Health

CARBOGEN AMCIS is fully committed to provide a secure and safe environment for our employees and local community.

Supply Chain Management

Sourcing raw materials, facilitating secure transfers, managing storage and a rapid supply and ensuring a timely delivery to our customers while maintaining a full compliance to the standards – are operated reliably by our Supply Chain Management team.

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Vitamin D Analogs & D2

Over 70 years Vitamin D experience in The Netherlands

CARBOGEN AMCIS B.V. is active in the manufacturing, marketing/sales and distribution of Vitamin D analogs and Vitamin D2 (Ergocalciferol). These ingredients (APIs) are mainly used in pharmaceutical products. Through our history of Philips, Roxane, Duphar, and Solvay Pharmaceuticals, we have more than 70 years of experience in the development, production, and sales of these ingredients (APIs). Our production site in the Netherlands is operated under cGMP regime, is certified as EU GMP, and classified as acceptable by US FDA for API manufacturing. We have our own testing laboratory.

We control the complete supply chain by manufacturing our own raw material for these Vitamin D ingredients. From the Netherlands we ship these products worldwide. We can also be your partner for HIPO contract manufacturing and/or contract research (CRAMS) of Vitamin D related intermediates and APIs.

  • Alfacalcidol PhEur / IP / BP

    Application:
    Alfacalcidol is a Vitamin D3 analog for the Pharmaceutical and Veterinary industry. Alfacalcidol is especially used to prevent and treat osteoporosis or decalcification of bones. The substance is also active against other bone growth disorders such as osteomalacia, rickets and specific liver and parathyroid glands abnormalities. It is also used for the treatment and prevention of secondary hyperparathyroidism associated with chronic kidney disease (CKD).

    Specification:
    Names: Alfacalcidol; 1α-hydroxycholecalciferol; 1α-hydroxyvitamin D3
    Content Alfacalcidol (HPLC) is 97.0-102.0%

    CAS: 41294-56-8

    Regulatory: CEP/CoS and DMF available

    Download Product Sheet

  • Calcitriol PhEur / USP / IP / BP

    Application:
    Calcitriol is a Vitamin D3 analog for the Pharmaceutical and Veterinary industry. Calcitriol is especially used to prevent and treat osteoporosis or decalcification of bones. The substance is also active against other bone growth disorders such as osteomalacia, rickets and specific liver and parathyroid glands abnormalities. It is also used for the treatment and prevention of secondary hyperparathyroidism associated with chronic kidney disease (CKD).

    Specification:
    Names: Calcitriol; 1α,25-dihydroxycholecalciferol; 1α,25-dihydroxyvitamin D3; 1,25 DHCC
    Content Calcitriol (HPLC) is 97.0-102.0%

    CAS: 32222-06-3

    Regulatory: CEP/CoS and DMF available

    Download Product Sheet

  • Calcifediol PhEur / USP / IP / BP

    Application:
    Calcifediol is a Vitamin D3 analog for the Pharmaceutical and Veterinary industry. Calcifediol is especially used to prevent and treat osteoporosis or decalcification of bones. The substance is also active against other bone growth disorders such as rickets, osteomalacia and specific liver and parathyroid glands abnormalities. It is also used for the treatment and prevention of secondary hyperparathyroidism associated with chronic kidney disease (CKD).

    Specification:
    Names: Calcifediol; 25-hydroxyvitamin D3;25-hydroxycholecalciferol; 25-HCC
    Content Calcifediol (HPLC) is 97.0-102.0%

    CAS: 63283-36-3 (monohydrate), 19356-17-3 (anhydrous)

    Regulatory: CEP/CoS and DMF available

    Download Product Sheet

  • Dihydrotachysterol PhEur

    Application:
    Dihydrotachysterol-2 (DHT-2) is a Vitamin D2 analog for the Pharmaceutical industry. DHT2 is used in the prevention and treatment of several bone growth disorders such as osteoporosis. Besides this the substance is also used to treat several abnormalities of the parathyroid glands such as hypoprathyroidism.

    Specification:
    Chemical name: Dihydrotachysterol-2; DHT-2; DHT
    Content Dihydrotachysterol-2 (HPLC) is 97.0-102.0%

    CAS: 67-96-9

    Regulatory: CEP/CoS available

    Download Product Sheet

  • Ercalcidiol

    Application:
    Ercalcidiol is an active Vitamin D2 analog for the Pharmaceutical industry. Ercalcidiol can be used for the treatment of disorders in Calcium and Phosphorhomeostasis. It can also be used as a marker for Vitamin D3 catabolism and a predictor of serum 25-hydroxycholecalciferol response to Vitamin D3 supplementation.

    Specification:
    Chemical name: Ercalcidiol; 25-hydroxyergocalciferol; 25-hydroxy D2
    Content Ercalcidiol (HPLC) is ≥ 90%

    CAS: 21343-40-8

    Regulatory: Non-GMP material

    Download Product Sheet

  • Ergocalciferol PhEur / USP / BP - Vitamin D2 pure

    Application:
    Vitamin D2 is used to ensure the right concentration of calcium and phosphorus in the blood. Ergocalciferol is used to treat and prevent bone growth disorders such as osteomalacia, rickets and osteoporosis. Recent research shows that Vitamin D2 can also be of paramount importance to prevent other abnormalities and diseases as well. Several forms of cancer and auto-immune diseases are targeted by several research companies. Vitamin D2 can also be used as starting material for APIs.

    Specification:
    Names: Vitamin D2 pure; Ergocalciferol; Calciferol
    Content Ergocalciferol is 97.0-102.0%; 1 gram is equivalent to 40,000,000 IU of Vitamin D2

    CAS: 50-14-6

    Regulatory: DMF available (an ASMF has been filed and accepted in several European countries)

    Download Product Sheet

  • Paricalcitol USP

    Application:
    Paricalcitol is an active Vitamin D2 analog for the Pharmaceutical industry. Paricalcitol is used for the treatment and prevention of secondary hyperparathyroidism associated with chronic kidney disease (CKD). It has been shown to reduce parathyroid hormone levels by inhibiting its synthesis and secretion.

    Specification:
    Names: Paricalcitol; 19-NOR-1α,25-dihydroxyergocalciferol; 19-NOR-1α,25-dihydroxy D2
    Content Paricalcitol (HPLC) is 97.0-103.0%

    CAS: 131918-61-1

    Regulatory: DMF available (an ASMF has been filed and accepted in several European countries)

    Download Product Sheet

  • Secalciferol

    Application:
    Secalciferol is an active Vitamin D analog for the Pharmaceutical industry. Secalciferol can be used for the treatment of disorders in Calcium and Phosphor homeostasis. It can also be used as a marker for Vitamin D3 catabolism and a predictor of serum 25-hydroxycholecalciferol response to Vitamin D3 supplementation.

    Specification:
    Names: Secalciferol; 24R,25-dihydroxycholecalciferol; 24R,25-dihydroxyvitamin D3; 24R 25 DHCC
    Content Secalciferol (HPLC) is ≥ 95%

    CAS: 55721-11-4

    Regulatory: Non-GMP material

    Download Product Sheet

  • Years

    More than

    70

    years

    of experience

  • Kilogrammes

    Production from mg to several

    100

    metric

    tons

  • Products

    Products distributed across

    65

    +

    countries

For more information
download our Company Profile 
brochure or contact us today.

Download Brochure

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Flow Chemistry

Widen your synthetic tool box

Scale-up can be tough even for reactions that are well-established in the lab. With profound expertise in the field of flow chemistry CARBOGEN AMCIS has the capability to help you controlling conditions and handling the risk as reactive volumes are small at any time. The range of applicable conditions such as temperature and pressure is becoming larger than in classical batch reactors. Not only will our experience in this method allow you a safer reaction and easier scale-up - it will also increase the purity of a product.

CARBOGEN AMCIS Flow Chemistry capabilities:

  • Process intensification – temperature control, mixing, pressure, concentration
  • Resolving scale-up problems
  • Handling of critical reactions and control of reaction parameters
  • Manufacturing under GMP

CARBOGEN AMCIS Flow Chemistry expert

My work at CARBOGEN AMCIS allows me to live out my curiosity and generate new knowledge. It's motivating to collaborate with a multi-national group of people and to approach tricky chemical and technical challenges every day.

Franz - Senior Scientist Development, Neuland

Why consider Flow Chemistry for your project

  • Higher purity

  • Safer processing

  • Easy scale-up

  • Real-time monitoring

  • Rapid reaction optimization

Typical fits for Flow Chemistry

  • Fast reactions

  • Hazardous reagents and intermediates

  • Scale-up issues

  • Extreme reaction conditions

For more information
download our Flow Chemistry
case study or contact us today.

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Environment, Safety & Health

Safety and regulatory compliance is paramount throughout our processes

CARBOGEN AMCIS is dedicated to developing and maintaining voluntary safety, environmental and health standards above and beyond the standard legal requirements, in order to provide a safe and healthy workplace for our employees.

We also provide a secure and safe environment for our neighbors in the communities we operate within. This commitment starts with the leadership of our company and extends to every colleague.

My work has a daily impact on many people, as we continually strive to increase the company level of health and safety whilst minimising our environmental impact. At the end of the day, I want everybody to return home safely to their families.

Gavin - Head of ESH, Bubendorf

Environment

  • Full Swiss legal compliance
  • Waste air treatment with scrubber or charcoal adsorbing systems (ALURA)
  • Incineration of all chemical waste streams (also aqueous)

Health

  • Categorization of all APIs and intermediates (in-house toxicologist)
  • Industrial hygiene monitoring program
  • State of the art containment systems (e.g. glove boxes / pressure cascades / barrier benches)
  • Illness and injury reporting

Safety

  • Thermal process safety (in-house safety lab, risk analyses for all chemical processes)
  • Instructions performed for each production procedure
  • ESH training program (including annual safety days)
  • Incident and near-miss reporting
  • Preventive maintenance for equipment and infrastructure
  • GHS (Globally Harmonized System) compliant classification, labelling and packaging of dangerous goods
  • Internal fire response and first aid groups

For more information
download our Company Profile
brochure or contact us today.

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