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 Estrogens, esterified manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estrogens, esterified, including repackagers and relabelers. The FDA regulates Estrogens, esterified manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estrogens, esterified 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 Estrogens, esterified manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Estrogens, esterified supplier is an individual or a company that provides Estrogens, esterified active pharmaceutical ingredient (API) or Estrogens, esterified finished formulations upon request. The Estrogens, esterified suppliers may include Estrogens, esterified API manufacturers, exporters, distributors and traders.
click here to find a list of Estrogens, esterified 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 Estrogens, esterified Drug Master File in Japan (Estrogens, esterified JDMF) empowers Estrogens, esterified 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 Estrogens, esterified JDMF during the approval evaluation for pharmaceutical products. At the time of Estrogens, esterified 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 Estrogens, esterified suppliers with JDMF on PharmaCompass.
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