Aspen API. More than just an API.
01 1Aspen Oss B. V.
02 1Valdepharm
01 1Norethisterone acetate
02 1norethisterone acetate
01 1Luxembourg
02 1Netherlands
Aspen API. More than just an API.
Registration Number : 218MF10585
Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands
Initial Date of Registration : 2006-06-22
Latest Date of Registration : 2019-10-01
Registration Number : 230MF10159
Registrant's Address : Parc Industriel d'Incarville Parc de la Fringale CS 10606 27106 Val de Reuil Cedex Fr...
Initial Date of Registration : 2018-11-28
Latest Date of Registration : 2021-02-10
A Norethisterone Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Norethisterone Acetate, including repackagers and relabelers. The FDA regulates Norethisterone Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Norethisterone Acetate 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 Norethisterone Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Norethisterone Acetate supplier is an individual or a company that provides Norethisterone Acetate active pharmaceutical ingredient (API) or Norethisterone Acetate finished formulations upon request. The Norethisterone Acetate suppliers may include Norethisterone Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Norethisterone Acetate 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 Norethisterone Acetate Drug Master File in Japan (Norethisterone Acetate JDMF) empowers Norethisterone Acetate 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 Norethisterone Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Norethisterone Acetate 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 Norethisterone Acetate suppliers with JDMF on PharmaCompass.
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