01 1Sankyo Chemical Co., Ltd.
01 1Outsider regulations hydrochloride para butyl aminobenzoate diethylaminoethyl(Production only)
01 1Japan
Registration Number : 220MF10139
Registrant's Address : 1-4-16 Dojimahama, Kita-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2008-06-10
Latest Date of Registration : 2008-06-10
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A T201 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of T201, including repackagers and relabelers. The FDA regulates T201 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. T201 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 T201 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A T201 supplier is an individual or a company that provides T201 active pharmaceutical ingredient (API) or T201 finished formulations upon request. The T201 suppliers may include T201 API manufacturers, exporters, distributors and traders.
click here to find a list of T201 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 T201 Drug Master File in Japan (T201 JDMF) empowers T201 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 T201 JDMF during the approval evaluation for pharmaceutical products. At the time of T201 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 T201 suppliers with JDMF on PharmaCompass.
