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01 1Evonik Rexim (Nanning) Pharmaceutical Co. , Ltd.
02 1Ajinomoto do Brazil Industria e Comercio de Alimentos Ltda.
03 1Kamiishiwa Anko Acid Co., Ltd.
04 1Kyowa Hakko Bio Co., Ltd.
05 1SHINE STAR (HUBEI) BIOLOGICAL ENGINEERING CO. , LTD.
06 1Shanghai Ajinomoto Amino Acid Co., Ltd.
07 1Taenaka Mining Co., Ltd.
01 4Japanese Pharmacopoeia L- isoleucine (production only)
02 1Japanese Pharmacopoeia L-isoleucine (manufacturing only)
03 1L- isoleucine L-Isoleucine
04 1L-Isoleucine
01 1China
02 1Germany
03 4Japan
04 1Blank
Registration Number : 218MF10978
Registrant's Address : No. 10 Wenjiang Road, Wuming District, Nanning, 530100, Guangxi, P. R. China
Initial Date of Registration : 2006-12-01
Latest Date of Registration : 2011-11-07
Japanese Pharmacopoeia L-Isoleucine (for manufacturing only)
Registration Number : 219MF10243
Registrant's Address : Avenida Oriento, s/n Bairro Entre Rios-CEP 18500-000, Laranjal Paulista, SP, Brazil
Initial Date of Registration : 2007-07-17
Latest Date of Registration : 2007-07-17
Japanese Pharmacopoeia L-Isoleucine (for manufacturing only)
Registration Number : 226MF10084
Registrant's Address : No. 718, Rongle East Road, Songjiang District, Shanghai, People's Republic of China
Initial Date of Registration : 2014-05-09
Latest Date of Registration : 2014-05-09
Japanese Pharmacopoeia L-Isoleucine (for manufacturing only)
Registration Number : 217MF10221
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 : 305MF10063
Registrant's Address : No. 666 Chanling Avenue, Douhudi Town, Gong An, Jingzhou, Hubei, P. R. China
Initial Date of Registration : 2023-05-17
Latest Date of Registration : 2023-05-17
Japanese Pharmacopoeia L-Isoleucine (for manufacturing only)
Registration Number : 217MF10288
Registrant's Address : 452 Oshiba, Mobara City, Chiba Prefecture
Initial Date of Registration : 2005-06-20
Latest Date of Registration : 2009-12-03
Japanese Pharmacopoeia L-Isoleucine (for manufacturing only)
Registration Number : 229MF10079
Registrant's Address : No. 158, Xinduan Road, Gongyuan District, Qingpu, Shanghai City, China
Initial Date of Registration : 2017-04-11
Latest Date of Registration : 2017-04-11
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A Isoleucine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isoleucine, including repackagers and relabelers. The FDA regulates Isoleucine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isoleucine 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 Isoleucine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isoleucine supplier is an individual or a company that provides Isoleucine active pharmaceutical ingredient (API) or Isoleucine finished formulations upon request. The Isoleucine suppliers may include Isoleucine API manufacturers, exporters, distributors and traders.
click here to find a list of Isoleucine 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 Isoleucine Drug Master File in Japan (Isoleucine JDMF) empowers Isoleucine 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 Isoleucine JDMF during the approval evaluation for pharmaceutical products. At the time of Isoleucine 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 Isoleucine suppliers with JDMF on PharmaCompass.
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