01 1Bayer AG
02 1FORMOSA LABORATORIES, INC.
03 1INDUSTRIALE CHIMICA s. r. l.
04 1ScinoPharm Taiwan, Ltd.
01 3Levonorgestrel
02 1Norgestrel
01 1Germany
02 1Italy
03 2Taiwan
Registration Number : 218MF10828
Registrant's Address : Kaiser-Wilhelm-Allee 1,51373 Leverkusen, Germany
Initial Date of Registration : 2006-10-20
Latest Date of Registration : 2006-10-20
Registration Number : 228MF10159
Registrant's Address : 36 Hoping Street, Louchu, Taoyuan 33842, Taiwan
Initial Date of Registration : 2016-08-10
Latest Date of Registration : 2017-02-22
Registration Number : 221MF10183
Registrant's Address : Via E. H. Grieg, 13, 21047 Saronno (Varese) ITALY
Initial Date of Registration : 2009-08-13
Latest Date of Registration : 2023-02-15
Registration Number : 221MF10292
Registrant's Address : No. 1, Nan-Ke 8th Road, Shan-Hua, Tainan 74144 Taiwan
Initial Date of Registration : 2009-12-25
Latest Date of Registration : 2020-07-29
A (-)-Norgestrel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (-)-Norgestrel, including repackagers and relabelers. The FDA regulates (-)-Norgestrel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (-)-Norgestrel 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 (-)-Norgestrel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (-)-Norgestrel supplier is an individual or a company that provides (-)-Norgestrel active pharmaceutical ingredient (API) or (-)-Norgestrel finished formulations upon request. The (-)-Norgestrel suppliers may include (-)-Norgestrel API manufacturers, exporters, distributors and traders.
click here to find a list of (-)-Norgestrel 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 (-)-Norgestrel Drug Master File in Japan ((-)-Norgestrel JDMF) empowers (-)-Norgestrel 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 (-)-Norgestrel JDMF during the approval evaluation for pharmaceutical products. At the time of (-)-Norgestrel 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 (-)-Norgestrel suppliers with JDMF on PharmaCompass.
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