01 1FORMOSA LABORATORIES, INC.
02 1Shiratori Pharmaceutical Co., Ltd.
01 1Gimeracil
02 1Gimeracil production dedicated
01 1Japan
02 1Taiwan
Registration Number : 224MF10135
Registrant's Address : 36 Hoping Street, Louchu, Taoyuan 33842, Taiwan
Initial Date of Registration : 2012-07-19
Latest Date of Registration : 2013-05-22
Registration Number : 224MF10037
Registrant's Address : 6-11-24 Tsudanuma, Narashino City, Chiba Prefecture
Initial Date of Registration : 2012-02-23
Latest Date of Registration : 2016-04-22
A Gimeracil-13C3 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gimeracil-13C3, including repackagers and relabelers. The FDA regulates Gimeracil-13C3 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gimeracil-13C3 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 Gimeracil-13C3 supplier is an individual or a company that provides Gimeracil-13C3 active pharmaceutical ingredient (API) or Gimeracil-13C3 finished formulations upon request. The Gimeracil-13C3 suppliers may include Gimeracil-13C3 API manufacturers, exporters, distributors and traders.
click here to find a list of Gimeracil-13C3 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 Gimeracil-13C3 Drug Master File in Japan (Gimeracil-13C3 JDMF) empowers Gimeracil-13C3 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 Gimeracil-13C3 JDMF during the approval evaluation for pharmaceutical products. At the time of Gimeracil-13C3 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 Gimeracil-13C3 suppliers with JDMF on PharmaCompass.
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