Aspen API. More than just an API.
01 1Aspen Oss B. V.
02 1Aresko Life Sciences Private Limited
03 1Bayer AG
04 1Dr. Reddy's Laboratories Limited office and manufacturing site in Mexico
05 1Zhejiang Xianju Junye Pharmaceutical Co. , Ltd.
01 1Norethindrone
02 4Norethisterone
01 1China
02 1Gabon
03 1Germany
04 1Netherlands
05 1Blank
Aspen API. More than just an API.
Registration Number : 218MF10846
Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands
Initial Date of Registration : 2006-10-20
Latest Date of Registration : 2021-05-24
Registration Number : 219MF10281
Registrant's Address : Kaiser-Wilhelm-Allee 1,51373 Leverkusen, Germany
Initial Date of Registration : 2007-09-10
Latest Date of Registration : 2012-11-28
Registration Number : 218MF11007
Registrant's Address : Km. 4.5 Carretera Federal Cuernavaca-Cuautla 62578 Jiutepec, Morelos, Mexico
Initial Date of Registration : 2006-12-18
Latest Date of Registration : 2006-12-18
Registration Number : 228MF10157
Registrant's Address : No. 1 Junye Road, Xianju, Taizhou, Zhejiang, China
Initial Date of Registration : 2016-08-10
Latest Date of Registration : 2016-08-10
Registration Number : 306MF10093
Registrant's Address : Village - Sakhanpur, P. O. - Pirumadara - 244715, Tehsil - Ramnagar, Distt. - Nainita...
Initial Date of Registration : 2024-07-03
Latest Date of Registration : 2024-07-03
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A Norethisterone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Norethisterone, including repackagers and relabelers. The FDA regulates Norethisterone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Norethisterone 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Norethisterone supplier is an individual or a company that provides Norethisterone active pharmaceutical ingredient (API) or Norethisterone finished formulations upon request. The Norethisterone suppliers may include Norethisterone API manufacturers, exporters, distributors and traders.
click here to find a list of Norethisterone 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 Drug Master File in Japan (Norethisterone JDMF) empowers Norethisterone 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Norethisterone 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 suppliers with JDMF on PharmaCompass.
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