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 Levonorgestrel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levonorgestrel, including repackagers and relabelers. The FDA regulates Levonorgestrel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levonorgestrel 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 Levonorgestrel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levonorgestrel supplier is an individual or a company that provides Levonorgestrel active pharmaceutical ingredient (API) or Levonorgestrel finished formulations upon request. The Levonorgestrel suppliers may include Levonorgestrel API manufacturers, exporters, distributors and traders.
click here to find a list of Levonorgestrel 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 Levonorgestrel Drug Master File in Japan (Levonorgestrel JDMF) empowers Levonorgestrel 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 Levonorgestrel JDMF during the approval evaluation for pharmaceutical products. At the time of Levonorgestrel 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 Levonorgestrel suppliers with JDMF on PharmaCompass.
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