01 1FUJIFILM Wako Chemical Co., Ltd.
01 1Solithromycin
01 1Japan
Registration Number : 231MF10087
Registrant's Address : 3558 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki Prefecture
Initial Date of Registration : 2019-04-11
Latest Date of Registration : 2019-04-11
A Solithromycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Solithromycin, including repackagers and relabelers. The FDA regulates Solithromycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Solithromycin 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 Solithromycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Solithromycin supplier is an individual or a company that provides Solithromycin active pharmaceutical ingredient (API) or Solithromycin finished formulations upon request. The Solithromycin suppliers may include Solithromycin API manufacturers, exporters, distributors and traders.
click here to find a list of Solithromycin 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 Solithromycin Drug Master File in Japan (Solithromycin JDMF) empowers Solithromycin 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 Solithromycin JDMF during the approval evaluation for pharmaceutical products. At the time of Solithromycin 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 Solithromycin suppliers with JDMF on PharmaCompass.
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