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01 1Evonik Rexim (Nanning) Pharmaceutical Co. , Ltd.
02 1Ajinomoto Co., Inc.
03 1Alps Pharmaceutical Co., Ltd.
04 1Kyowa Hakko Bio Co., Ltd.
05 1Taenaka Mining Co., Ltd.
01 3Japanese Pharmacopoeia L- aspartic acid (production only)
02 1L- aspartic acid L-Aspartic acid
03 1Potassium L- aspartic acid
01 1Germany
02 4Japan
Registration Number : 218MF10976
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 : 2019-10-25
Japanese Pharmacopoeia L-Aspartic Acid (for manufacturing only)
Registration Number : 218MF10641
Registrant's Address : 1-15-1 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2006-07-20
Latest Date of Registration : 2006-07-20
Registration Number : 217MF11041
Registrant's Address : 2-10-50 Mukaimachi, Furukawa-cho, Hida-shi, Gifu Prefecture
Initial Date of Registration : 2005-12-02
Latest Date of Registration : 2006-05-18
Japanese Pharmacopoeia L-Aspartic Acid (for manufacturing only)
Registration Number : 219MF10189
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2007-06-08
Latest Date of Registration : 2007-06-08
Japanese Pharmacopoeia L-Aspartic Acid (for manufacturing only)
Registration Number : 228MF10236
Registrant's Address : 452 Oshiba, Mobara City, Chiba Prefecture
Initial Date of Registration : 2016-12-26
Latest Date of Registration : 2016-12-26
A L- Aspartic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L- Aspartic acid, including repackagers and relabelers. The FDA regulates L- Aspartic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L- Aspartic acid 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- Aspartic acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L- Aspartic acid supplier is an individual or a company that provides L- Aspartic acid active pharmaceutical ingredient (API) or L- Aspartic acid finished formulations upon request. The L- Aspartic acid suppliers may include L- Aspartic acid API manufacturers, exporters, distributors and traders.
click here to find a list of L- Aspartic acid 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- Aspartic acid Drug Master File in Japan (L- Aspartic acid JDMF) empowers L- Aspartic acid 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- Aspartic acid JDMF during the approval evaluation for pharmaceutical products. At the time of L- Aspartic acid 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- Aspartic acid suppliers with JDMF on PharmaCompass.
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