01 1Alps Pharmaceutical Co., Ltd.
01 1Japanese Pharmacopoeia berberine chloride hydrate
01 1Japan
Japanese Pharmacopoeia Berberine Chloride Hydrate
Registration Number : 221MF10207
Registrant's Address : 2-10-50 Mukaimachi, Furukawa-cho, Hida-shi, Gifu Prefecture
Initial Date of Registration : 2009-09-24
Latest Date of Registration : 2020-04-22
A Berberine Chloride Hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Berberine Chloride Hydrate, including repackagers and relabelers. The FDA regulates Berberine Chloride Hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Berberine Chloride Hydrate 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 Berberine Chloride Hydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Berberine Chloride Hydrate supplier is an individual or a company that provides Berberine Chloride Hydrate active pharmaceutical ingredient (API) or Berberine Chloride Hydrate finished formulations upon request. The Berberine Chloride Hydrate suppliers may include Berberine Chloride Hydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Berberine Chloride Hydrate 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 Berberine Chloride Hydrate Drug Master File in Japan (Berberine Chloride Hydrate JDMF) empowers Berberine Chloride Hydrate 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 Berberine Chloride Hydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Berberine Chloride Hydrate 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 Berberine Chloride Hydrate suppliers with JDMF on PharmaCompass.
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