Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
01 1Evonik Rexim (Nanning) Pharmaceutical Co. , Ltd.
02 2Evonik Rexim S. A. S.
03 1Ajinomoto Health & Nutrition North America, Inc.
04 1Kamiishiwa Anko Acid Co., Ltd.
05 2Kyowa Hakko Bio Co., Ltd.
06 1Nippon Rika Pharmaceuticals Co., Ltd.
07 1Sekisui Medical Co., Ltd.
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Registration Number : 227MF10148
Registrant's Address : No. 46 Wenjiang Road, Wuming District, Nanning, 530199, Guangxi, P. R. China
Initial Date of Registration : 2015-05-26
Latest Date of Registration : 2019-06-18
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Registration Number : 218MF10962
Registrant's Address : 33, Rue de Verdun Ham, France
Initial Date of Registration : 2006-12-01
Latest Date of Registration : 2012-01-16
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Registration Number : 218MF10658
Registrant's Address : 33, Rue De Verdun Ham France
Initial Date of Registration : 2006-07-24
Latest Date of Registration : 2006-07-24
A (L)-SERINE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (L)-SERINE, including repackagers and relabelers. The FDA regulates (L)-SERINE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (L)-SERINE API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of (L)-SERINE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (L)-SERINE supplier is an individual or a company that provides (L)-SERINE active pharmaceutical ingredient (API) or (L)-SERINE finished formulations upon request. The (L)-SERINE suppliers may include (L)-SERINE API manufacturers, exporters, distributors and traders.
click here to find a list of (L)-SERINE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The (L)-SERINE Drug Master File in Japan ((L)-SERINE JDMF) empowers (L)-SERINE API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the (L)-SERINE JDMF during the approval evaluation for pharmaceutical products. At the time of (L)-SERINE JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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