01 1Dijia Pharmaceutical Group Co. , Ltd.
02 1Eisai Co., Ltd.
03 1HETERO DRUGS LIMITED.
04 1JUBILANT ORGANOSYS LIMITED.
05 1JUBILANT PHARMOVA LIMITED
06 1KOLON LIFE SCIENCE, INC.
07 1Megafine Pharma (P) Limited
08 1Organic Synthesis Chemicals Co., Ltd.
09 2Ryoto Fine Co., Ltd.
10 1Sanyo Chemical Research Institute Co., Ltd.
11 1Synthimed Labs Private Limited
12 1TAPI Croatia Industries Ltd.
13 1VASUDHA PHARMA CHEM LIMITED
14 1Wavelength Enterprises Ltd
15 1Yoshindo Co., Ltd.
16 2Zhejiang East Asia Pharmaceutical Co. , Ltd.
A Donepezil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Donepezil, including repackagers and relabelers. The FDA regulates Donepezil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Donepezil 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 Donepezil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Donepezil supplier is an individual or a company that provides Donepezil active pharmaceutical ingredient (API) or Donepezil finished formulations upon request. The Donepezil suppliers may include Donepezil API manufacturers, exporters, distributors and traders.
click here to find a list of Donepezil 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 Donepezil Drug Master File in Japan (Donepezil JDMF) empowers Donepezil 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 Donepezil JDMF during the approval evaluation for pharmaceutical products. At the time of Donepezil 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 Donepezil suppliers with JDMF on PharmaCompass.
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