01 1Aurisco Pharmaceutical Co. , Ltd.
02 1Hetero Labs Limited
01 2Eplerenone
01 1China
02 1India
Registration Number : 304MF10019
Registrant's Address : Badu Industrial Park Zone, Tiantai, Zhejiang province, 317200, P. R. China
Initial Date of Registration : 2022-01-26
Latest Date of Registration : 2022-01-26
Registration Number : 304MF10031
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana I...
Initial Date of Registration : 2022-02-10
Latest Date of Registration : 2022-02-10
A Eplerenone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eplerenone, including repackagers and relabelers. The FDA regulates Eplerenone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eplerenone 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 Eplerenone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eplerenone supplier is an individual or a company that provides Eplerenone active pharmaceutical ingredient (API) or Eplerenone finished formulations upon request. The Eplerenone suppliers may include Eplerenone API manufacturers, exporters, distributors and traders.
click here to find a list of Eplerenone 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 Eplerenone Drug Master File in Japan (Eplerenone JDMF) empowers Eplerenone 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 Eplerenone JDMF during the approval evaluation for pharmaceutical products. At the time of Eplerenone 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 Eplerenone suppliers with JDMF on PharmaCompass.
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