01 2Hebei Hualong Pharmaceutical Co. , Ltd.
01 1Cobamamide
02 1Kobamamid
01 2China
Registration Number : 227MF10292
Registrant's Address : No. 8, Weier Road, Ningjin Salinization Industrial Park, Xingtai, Hebei Province, Chi...
Initial Date of Registration : 2015-12-24
Latest Date of Registration : 2015-12-24
Registration Number : 303MF10059
Registrant's Address : No. 8, Weier Road, Ningjin Salinization Industrial Park, Xingtai, Hebei Province, Chi...
Initial Date of Registration : 2021-04-02
Latest Date of Registration : 2021-04-02
A Cobamamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cobamamide, including repackagers and relabelers. The FDA regulates Cobamamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cobamamide 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 Cobamamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cobamamide supplier is an individual or a company that provides Cobamamide active pharmaceutical ingredient (API) or Cobamamide finished formulations upon request. The Cobamamide suppliers may include Cobamamide API manufacturers, exporters, distributors and traders.
click here to find a list of Cobamamide 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 Cobamamide Drug Master File in Japan (Cobamamide JDMF) empowers Cobamamide 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 Cobamamide JDMF during the approval evaluation for pharmaceutical products. At the time of Cobamamide 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 Cobamamide suppliers with JDMF on PharmaCompass.
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