Aspen API. More than just an API.
01 1Aspen Oss B. V.
01 1Estriol
01 1Netherlands
Aspen API. More than just an API.
Registration Number : 218MF10506
Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands
Initial Date of Registration : 2006-05-15
Latest Date of Registration : 2024-11-13
A Estriol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estriol, including repackagers and relabelers. The FDA regulates Estriol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estriol 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 Estriol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Estriol supplier is an individual or a company that provides Estriol active pharmaceutical ingredient (API) or Estriol finished formulations upon request. The Estriol suppliers may include Estriol API manufacturers, exporters, distributors and traders.
click here to find a list of Estriol 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 Estriol Drug Master File in Japan (Estriol JDMF) empowers Estriol 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 Estriol JDMF during the approval evaluation for pharmaceutical products. At the time of Estriol 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 Estriol suppliers with JDMF on PharmaCompass.
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