Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
01 1Evonik Rexim S. A. S.
02 1Evonik ReximS. A. S.
03 1Ajinomoto Health & Nutrition North America, Inc.
04 1Juzen Chemical Co., Ltd.
05 2Kyowa Hakko Bio Co., Ltd.
06 1Star Lake Bioscience Co. , Inc. Zhaoqing Guangdong
01 3Japanese Pharmacopoeia L- proline (production only)
02 2L- proline L-Proline
03 1Lee plug Li Furojin L- proline
04 1Proline
01 1China
02 2Germany
03 4Japan
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Registration Number : 218MF10964
Registrant's Address : 33, Rue de Verdun Ham, France
Initial Date of Registration : 2006-12-01
Latest Date of Registration : 2019-07-19
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Registration Number : 218MF10657
Registrant's Address : 33, Rue de Verdun Ham, France
Initial Date of Registration : 2006-07-24
Latest Date of Registration : 2006-07-24
Japanese Pharmacopoeia L-Proline (for manufacturing only)
Registration Number : 224MF10008
Registrant's Address : 4020 Ajinomoto Drive Raleigh, North Carolina 27610, USA
Initial Date of Registration : 2012-01-18
Latest Date of Registration : 2012-01-18
Registration Number : 229MF10003
Registrant's Address : 1-10 Kibacho, Toyama City, Toyama Prefecture
Initial Date of Registration : 2017-01-10
Latest Date of Registration : 2017-01-10
Japanese Pharmacopoeia L-Proline (for manufacturing only)
Registration Number : 224MF10012
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2012-01-18
Latest Date of Registration : 2012-01-18
Japanese Pharmacopoeia L-Proline (for manufacturing only)
Registration Number : 229MF10028
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2017-02-08
Latest Date of Registration : 2017-02-08
Registration Number : 229MF10150
Registrant's Address : 67 Gongnong Rd. , N. Zhaoqing City, Guangdong Province China, 526060
Initial Date of Registration : 2017-08-04
Latest Date of Registration : 2017-08-04
A (L)-PROLINE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (L)-PROLINE, including repackagers and relabelers. The FDA regulates (L)-PROLINE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (L)-PROLINE 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)-PROLINE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (L)-PROLINE supplier is an individual or a company that provides (L)-PROLINE active pharmaceutical ingredient (API) or (L)-PROLINE finished formulations upon request. The (L)-PROLINE suppliers may include (L)-PROLINE API manufacturers, exporters, distributors and traders.
click here to find a list of (L)-PROLINE 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)-PROLINE Drug Master File in Japan ((L)-PROLINE JDMF) empowers (L)-PROLINE 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)-PROLINE JDMF during the approval evaluation for pharmaceutical products. At the time of (L)-PROLINE JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of (L)-PROLINE suppliers with JDMF on PharmaCompass.
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