Aspen API. More than just an API.
01 1Aspen Oss B. V.
02 1Valdepharm
01 1Estradiol
02 1Estradiol hydrate
01 1Luxembourg
02 1Netherlands
Aspen API. More than just an API.
Registration Number : 218MF10586
Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands
Initial Date of Registration : 2006-06-22
Latest Date of Registration : 2022-04-20
Registration Number : 303MF10123
Registrant's Address : Parc Industriel d'Incarville Parc de la Fringale CS 10606 27106 Val de Reuil Cedex Fr...
Initial Date of Registration : 2021-08-02
Latest Date of Registration : 2021-08-02
A Estradiol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estradiol, including repackagers and relabelers. The FDA regulates Estradiol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estradiol 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Estradiol supplier is an individual or a company that provides Estradiol active pharmaceutical ingredient (API) or Estradiol finished formulations upon request. The Estradiol suppliers may include Estradiol API manufacturers, exporters, distributors and traders.
click here to find a list of Estradiol 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 Drug Master File in Japan (Estradiol JDMF) empowers Estradiol 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Estradiol 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 suppliers with JDMF on PharmaCompass.
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