01 1EUROAPI FRANCE
02 1Hebei Hualong Pharmaceutical Co. , Ltd.
03 1Hebei North China Pharmaceutical Huaheng Pharmaceutical Co. , Ltd.
04 1Meiji Seika Pharma Co., Ltd.
05 1North China Pharmaceutical Victor Co. , Ltd.
06 1SANOFI CHIMIE
01 2Cyanocobalamin
02 1Cyanocobalamin
03 1Day stations cyanocobalamin
04 2Japanese Pharmacopoeia cyanocobalamin (production only)
01 3China
02 2Gabon
03 1Japan
Registration Number : 304MF10125
Registrant's Address : No. 8, Weier Road, Ningjin Salinization Industrial Park, Xingtai, Hebei Province, Chi...
Initial Date of Registration : 2022-08-24
Latest Date of Registration : 2022-08-24
Japanese Pharmacopoeia Cyanocobalamin
Registration Number : 217MF10729
Registrant's Address : 2-4-16 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2010-02-04
Japanese Pharmacopoeia Cyanocobalamin (for manufacturing only)
Registration Number : 218MF10949
Registrant's Address : No. 9,Zhaiying North Street, Shijiazhuang, Hebei,P. R. China
Initial Date of Registration : 2006-11-24
Latest Date of Registration : 2013-05-15
Japanese Pharmacopoeia Cyanocobalamin (for manufacturing only)
Registration Number : 230MF10033
Registrant's Address : Xingyuan Street, Biological Industry Zone, Nanbaishe Town, Zhao County, Shijiazhuang,...
Initial Date of Registration : 2018-02-21
Latest Date of Registration : 2018-02-21
Registration Number : 218MF10373
Registrant's Address : 82 Avenue Raspail 94250 Gentilly France
Initial Date of Registration : 2006-03-20
Latest Date of Registration : 2007-12-19
Registration Number : 222MF10011
Registrant's Address : 15 rue Traversie(')re 75012 Paris France
Initial Date of Registration : 2010-01-07
Latest Date of Registration : 2024-02-07
A Vitamin B12 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vitamin B12, including repackagers and relabelers. The FDA regulates Vitamin B12 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vitamin B12 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 Vitamin B12 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vitamin B12 supplier is an individual or a company that provides Vitamin B12 active pharmaceutical ingredient (API) or Vitamin B12 finished formulations upon request. The Vitamin B12 suppliers may include Vitamin B12 API manufacturers, exporters, distributors and traders.
click here to find a list of Vitamin B12 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 Vitamin B12 Drug Master File in Japan (Vitamin B12 JDMF) empowers Vitamin B12 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 Vitamin B12 JDMF during the approval evaluation for pharmaceutical products. At the time of Vitamin B12 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 Vitamin B12 suppliers with JDMF on PharmaCompass.
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