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
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 17.alpha.-Ethynyl-19-nortestosterone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 17.alpha.-Ethynyl-19-nortestosterone, including repackagers and relabelers. The FDA regulates 17.alpha.-Ethynyl-19-nortestosterone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 17.alpha.-Ethynyl-19-nortestosterone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 17.alpha.-Ethynyl-19-nortestosterone supplier is an individual or a company that provides 17.alpha.-Ethynyl-19-nortestosterone active pharmaceutical ingredient (API) or 17.alpha.-Ethynyl-19-nortestosterone finished formulations upon request. The 17.alpha.-Ethynyl-19-nortestosterone suppliers may include 17.alpha.-Ethynyl-19-nortestosterone API manufacturers, exporters, distributors and traders.
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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 17.alpha.-Ethynyl-19-nortestosterone Drug Master File in Japan (17.alpha.-Ethynyl-19-nortestosterone JDMF) empowers 17.alpha.-Ethynyl-19-nortestosterone 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 17.alpha.-Ethynyl-19-nortestosterone JDMF during the approval evaluation for pharmaceutical products. At the time of 17.alpha.-Ethynyl-19-nortestosterone JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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