01 1Syn-Tech Chem. & Pharm. Co. , Ltd.
01 1Japan Bureau Clofibrate (for manufacturing only)
01 1Taiwan
Japanese Pharmacopoeia Clofibrate (for manufacturing only)
Registration Number : 218MF10071
Registrant's Address : No. 168 Kai-Yuan Rd. , Hsin-Ying Tainan City, 73055. Taiwan
Initial Date of Registration : 2006-01-27
Latest Date of Registration : 2010-04-05
A Clofibrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clofibrate, including repackagers and relabelers. The FDA regulates Clofibrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clofibrate 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 Clofibrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Clofibrate supplier is an individual or a company that provides Clofibrate active pharmaceutical ingredient (API) or Clofibrate finished formulations upon request. The Clofibrate suppliers may include Clofibrate API manufacturers, exporters, distributors and traders.
click here to find a list of Clofibrate 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 Clofibrate Drug Master File in Japan (Clofibrate JDMF) empowers Clofibrate 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 Clofibrate JDMF during the approval evaluation for pharmaceutical products. At the time of Clofibrate 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 Clofibrate suppliers with JDMF on PharmaCompass.
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