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 Chlorfenisate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chlorfenisate, including repackagers and relabelers. The FDA regulates Chlorfenisate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chlorfenisate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Chlorfenisate supplier is an individual or a company that provides Chlorfenisate active pharmaceutical ingredient (API) or Chlorfenisate finished formulations upon request. The Chlorfenisate suppliers may include Chlorfenisate API manufacturers, exporters, distributors and traders.
click here to find a list of Chlorfenisate 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 Chlorfenisate Drug Master File in Japan (Chlorfenisate JDMF) empowers Chlorfenisate 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 Chlorfenisate JDMF during the approval evaluation for pharmaceutical products. At the time of Chlorfenisate 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 Chlorfenisate suppliers with JDMF on PharmaCompass.
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