01 1Valdepharm
01 1Estradiol Valerate
01 1Luxembourg
Registration Number : 303MF10163
Registrant's Address : Parc Industriel d'Incarville Parc de la Fringale CS 10606 27106 Val de Reuil Cedex Fr...
Initial Date of Registration : 2021-11-10
Latest Date of Registration : 2022-09-14
A Estradiol Valerate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estradiol Valerate, including repackagers and relabelers. The FDA regulates Estradiol Valerate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estradiol Valerate 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 Estradiol Valerate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Estradiol Valerate supplier is an individual or a company that provides Estradiol Valerate active pharmaceutical ingredient (API) or Estradiol Valerate finished formulations upon request. The Estradiol Valerate suppliers may include Estradiol Valerate API manufacturers, exporters, distributors and traders.
click here to find a list of Estradiol Valerate 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 Estradiol Valerate Drug Master File in Japan (Estradiol Valerate JDMF) empowers Estradiol Valerate 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 Estradiol Valerate JDMF during the approval evaluation for pharmaceutical products. At the time of Estradiol Valerate 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 Estradiol Valerate suppliers with JDMF on PharmaCompass.
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