01 1Piramal Pharma Limited
02 1Uquifa Mexico, S. A. de C. V.
01 1Japanese Pharmacopoeia ketoconazole
02 1Ketoconazole
01 1Spain
02 1U.S.A
Japanese Pharmacopoeia Ketoconazole
Registration Number : 303MF10100
Registrant's Address : Digwal Village (Sy.Nos. 7-70, 70/1 and 70/2), Kohir Mandal, Sangareddy District-502 3...
Initial Date of Registration : 2021-07-02
Latest Date of Registration : 2021-07-02
Registration Number : 218MF10434
Registrant's Address : Calle 37 Este No. 126, CIVAC, 62578, Jiutepec, Morelos, Mexico
Initial Date of Registration : 2006-04-27
Latest Date of Registration : 2020-10-29
A Ketoconazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ketoconazole, including repackagers and relabelers. The FDA regulates Ketoconazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ketoconazole 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 Ketoconazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ketoconazole supplier is an individual or a company that provides Ketoconazole active pharmaceutical ingredient (API) or Ketoconazole finished formulations upon request. The Ketoconazole suppliers may include Ketoconazole API manufacturers, exporters, distributors and traders.
click here to find a list of Ketoconazole 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 Ketoconazole Drug Master File in Japan (Ketoconazole JDMF) empowers Ketoconazole 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 Ketoconazole JDMF during the approval evaluation for pharmaceutical products. At the time of Ketoconazole 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 Ketoconazole suppliers with JDMF on PharmaCompass.
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