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
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A .alpha.-(p-Chlorophenoxy)isobutyric acid, ethyl ester manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of .alpha.-(p-Chlorophenoxy)isobutyric acid, ethyl ester, including repackagers and relabelers. The FDA regulates .alpha.-(p-Chlorophenoxy)isobutyric acid, ethyl ester manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. .alpha.-(p-Chlorophenoxy)isobutyric acid, ethyl ester 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 .alpha.-(p-Chlorophenoxy)isobutyric acid, ethyl ester supplier is an individual or a company that provides .alpha.-(p-Chlorophenoxy)isobutyric acid, ethyl ester active pharmaceutical ingredient (API) or .alpha.-(p-Chlorophenoxy)isobutyric acid, ethyl ester finished formulations upon request. The .alpha.-(p-Chlorophenoxy)isobutyric acid, ethyl ester suppliers may include .alpha.-(p-Chlorophenoxy)isobutyric acid, ethyl ester API manufacturers, exporters, distributors and traders.
click here to find a list of .alpha.-(p-Chlorophenoxy)isobutyric acid, ethyl ester 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 .alpha.-(p-Chlorophenoxy)isobutyric acid, ethyl ester Drug Master File in Japan (.alpha.-(p-Chlorophenoxy)isobutyric acid, ethyl ester JDMF) empowers .alpha.-(p-Chlorophenoxy)isobutyric acid, ethyl ester 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 .alpha.-(p-Chlorophenoxy)isobutyric acid, ethyl ester JDMF during the approval evaluation for pharmaceutical products. At the time of .alpha.-(p-Chlorophenoxy)isobutyric acid, ethyl ester 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 .alpha.-(p-Chlorophenoxy)isobutyric acid, ethyl ester suppliers with JDMF on PharmaCompass.
We have 1 companies offering .alpha.-(p-Chlorophenoxy)isobutyric acid, ethyl ester
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