Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
01 1Evonik Rexim (Nanning) Pharmaceutical Co. , Ltd.
02 1Kyowa Hakko Bio Co., Ltd.
03 1Sekisui Medical Co., Ltd.
04 1Shanghai Ajinomoto Amino Acid Co., Ltd.
05 1Yoneyama Pharmaceutical Co., Ltd.
01 3Japanese Pharmacopoeia L- leucine (production only)
02 1L- leucine
03 1L- leucine L-Leucine
01 1Germany
02 4Japan
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Registration Number : 220MF10094
Registrant's Address : No. 10 Wenjiang Road, Wuming District, Nanning, 530100, Guangxi, P. R. China
Initial Date of Registration : 2008-03-28
Latest Date of Registration : 2011-11-07
Japanese Pharmacopoeia L-Leucine (for manufacturing only)
Registration Number : 217MF10807
Registrant's Address : No. 718, Rongle East Road, Songjiang District, Shanghai, People's Republic of China
Initial Date of Registration : 2005-11-01
Latest Date of Registration : 2006-11-15
Japanese Pharmacopoeia L-Leucine (for manufacturing only)
Registration Number : 217MF10235
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-15
Latest Date of Registration : 2006-11-15
Registration Number : 217MF10767
Registrant's Address : 3-13-5 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2005-10-20
Latest Date of Registration : 2006-05-18
Japanese Pharmacopoeia L-Leucine (for manufacturing only)
Registration Number : 217MF10310
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Doshomachi 2-3-11
Initial Date of Registration : 2005-07-11
Latest Date of Registration : 2021-10-21
A L-Leucine API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Leucine API, including repackagers and relabelers. The FDA regulates L-Leucine API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Leucine 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-Leucine API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Leucine API supplier is an individual or a company that provides L-Leucine API active pharmaceutical ingredient (API) or L-Leucine API finished formulations upon request. The L-Leucine API suppliers may include L-Leucine API API manufacturers, exporters, distributors and traders.
click here to find a list of L-Leucine 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-Leucine API Drug Master File in Japan (L-Leucine API JDMF) empowers L-Leucine 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-Leucine API JDMF during the approval evaluation for pharmaceutical products. At the time of L-Leucine 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-Leucine API suppliers with JDMF on PharmaCompass.
We have 5 companies offering L-Leucine API
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