Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
01 1Evonik Rexim (Nanning) Pharmaceutical Co. , Ltd.
02 1Evonik Rexim S. A. S.
03 1Ajinomoto Health & Nutrition North America, Inc.
04 1Kamiishiwa Anko Acid Co., Ltd.
05 1Kyowa Hakko Bio Co., Ltd.
06 1Shanghai Ajinomoto Amino Acid Co., Ltd.
01 4Japanese Pharmacopoeia L- alanine (production only)
02 2L- alanine L-Alanine
01 2Germany
02 3Japan
03 1Blank
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Registration Number : 218MF10975
Registrant's Address : No. 46 Wenjiang Road, Wuming District, Nanning, 530199, Guangxi, P. R. China
Initial Date of Registration : 2006-12-01
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 : 218MF10656
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-Alanine (for manufacturing only)
Registration Number : 223MF10057
Registrant's Address : No. 718, Rongle East Road, Songjiang District, Shanghai, People's Republic of China
Initial Date of Registration : 2011-04-28
Latest Date of Registration : 2011-04-28
Japanese Pharmacopoeia L-Alanine (for manufacturing only)
Registration Number : 222MF10252
Registrant's Address : 4020 Ajinomoto Drive Raleigh, North Carolina 27610, USA
Initial Date of Registration : 2010-10-28
Latest Date of Registration : 2010-10-28
Japanese Pharmacopoeia L-Alanine (for manufacturing only)
Registration Number : 222MF10247
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2010-10-28
Latest Date of Registration : 2010-10-28
Japanese Pharmacopoeia L-Alanine (for manufacturing only)
Registration Number : 229MF10074
Registrant's Address : No. 158, Xinduan Road, Gongyuan District, Qingpu, Shanghai City, China
Initial Date of Registration : 2017-04-07
Latest Date of Registration : 2017-04-07
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A L-Alanine API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Alanine API, including repackagers and relabelers. The FDA regulates L-Alanine API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Alanine API 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-Alanine API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Alanine API supplier is an individual or a company that provides L-Alanine API active pharmaceutical ingredient (API) or L-Alanine API finished formulations upon request. The L-Alanine API suppliers may include L-Alanine API API manufacturers, exporters, distributors and traders.
click here to find a list of L-Alanine API 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-Alanine API Drug Master File in Japan (L-Alanine API JDMF) empowers L-Alanine API 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-Alanine API JDMF during the approval evaluation for pharmaceutical products. At the time of L-Alanine API 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-Alanine API suppliers with JDMF on PharmaCompass.
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