FAQ
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1. Application handling – what kind of information will be supportive to get a first realistic feedback?
To make the first feasibility check more effective it is necessary to have the following information:
- Type of API?
- Quantities per year
- Primary packaging material
- Special handling, storage or transportation conditions
- What ever else would be relevant for you to check this application will also be relevant for us.
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2. Target market - do you only produce for German pharmaceutical market?
No, our Contract Manufacturing Network with 4 production sites delivers products in over 100 Countries around the world.
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3. Location of production - do you only produce in Germany?
No we have production sites in 3 European countries: Finland, Germany and Spain. All these companies are part of the Bayer HealthCare group and underlay the internal rules and Group advantages e. g. in Quality standard, powerful Procurement, protection of Intellectual property, well educated employees, etc.
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4. FDA approved - are you experienced with FDA audits?
Yes, your production sites are mainly FDA approved. Even ANVISA (Brazilian health authorities) has inspected nearly all 4 Supply Center.
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5. Japan quality – do you deliver to Japanese market?
Yes, we deliver also to Japanese market and are aware about the special requirements.
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6. Suppository - do you also offer suppository for contract manufacturing?
No, we have no production site within BHC which has this technology available.
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7. Syringes, aseptic creams, chewable tablets - I don't find syringes, aseptic creams or chewable tablets in your portfolio you offer?
Those are correct, but please contact us although because we have subsidiaries outside the Contract Manufacturing Network which offer these technologies. We will forward your request to the specialists for these technologies.
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8. Project leadtime - what is the leadtime of a change to your network?
We will work on the project with high engagement but finally the leadtime will be dependent from different aspects like registration timeline, critical steps in manufacturing process and last but not least the intensity of your support and your deep knowledge of your product. The project milestones and timeline will be agreed together and here you can relay on realistic statements. In some cases the purchase situation for packaging materials & ingredients might also be critical for the project.
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9. Animal Health products - do you offer animal health production?
Yes, for some technologies possible.
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10. Bayer Healthcare procurement - is it possible that Bayer will take over the complete ingredient and packaging material logistic?
Yes, for customer convenience this option of course is possible. Here the customer might have the advantage of the good negotiated prices by our powerful purchasing department. But all intermediate solutions up to the customer provides some or all components are also possible.
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11. Hormones - Do you offer human hormone production
No, our Contract Manufacturing Network are not allowed to handle this kind of API due to construction restrictions of the plant buildings and the handled manufactured portfolio.
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12. License business - Does BHC outlicense products for local markets?
This might be possible but has to be checked with business Management Groups - please use the contact for a detailed check. The Far East market is well supported by Bayer HealthCare representatives, thus in this area there is currently no need for license activities.
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13. Registration activities/support - Do you offer registration activities/support?
We support you with all necessary documents you need for your regulatory change. If you are looking for additional registration support we can offer to bring you in contact with an external supporter which also supports BHC in this area.
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14. Are you experience in contract manufacturing?
Yes, since many years we are acting as contract manufacturing partner for more then 30 external customers.
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15. Product Development - do you offer any kind of development?
No, with exception of development support with soft gelatine capsules, we are not able to offer development for products with contract manufacturing purposes. But we are supported by a galenic department which may support in optimization of manufacturing processes.
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16. Overall QC service – are their some QC aspects excluded?
No, we are able to offer a complete QC package. Starting with check of incoming packaging materials & ingredients, followed by in-process controls when applicable for a QC laboratory and ending with the final batch release (incl. market release if applicable).
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17. Do you offer contract manufacturing of vials/bottles in plastic?
Yes, you can find in the chapter of packaging and Liquid & Parenterals, that we are also able to offer different types of plastic packaging materials.
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18. Food supplement – do you offer manufacturing of Food supplement products?
Yes, a lot of our soft gelatine capsules are Food supplement products.
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19. Contracts - any kind of contracts needed?
Yes, we will start with a Secrecy Agreement, followed by a Supply Agreement and a Quality Assurance Agreement which is an integrated part of the Supply Agreement.
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Lyophilization – do you offer lyophilization into bulk powders/granules?
No, we only are able to freeze-dry liquids in vials or ampoules.
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Contact
Harald Milzarek
Contract Manufacturing Network
Tel. +49 (0)2 14 30 - 5 66 43
Fax +49 (0)2 14 30 - 9 65 66 43
E-Mail: Please use our contact form
Contract Manufacturing Network
Tel. +49 (0)2 14 30 - 5 66 43
Fax +49 (0)2 14 30 - 9 65 66 43
E-Mail: Please use our contact form