01 1ScinoPharm Taiwan, Ltd.
01 1Exemestane
01 1Taiwan
Registration Number : 222MF10188
Registrant's Address : No. 1, Nan-Ke 8th Road, Shan-Hua, Tainan 74144, Taiwan
Initial Date of Registration : 2010-07-02
Latest Date of Registration : 2020-11-18
A Exemestane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Exemestane, including repackagers and relabelers. The FDA regulates Exemestane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Exemestane 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 Exemestane manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Exemestane supplier is an individual or a company that provides Exemestane active pharmaceutical ingredient (API) or Exemestane finished formulations upon request. The Exemestane suppliers may include Exemestane API manufacturers, exporters, distributors and traders.
click here to find a list of Exemestane 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 Exemestane Drug Master File in Japan (Exemestane JDMF) empowers Exemestane 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 Exemestane JDMF during the approval evaluation for pharmaceutical products. At the time of Exemestane 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 Exemestane suppliers with JDMF on PharmaCompass.
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