01 1Janssen Pharmaceutica NV
02 1Yung Zip Chemical Ind. Co. , Ltd.
01 2Miconazole nitrate
01 1Taiwan
02 1U.S.A
Registration Number : 219MF10167
Registrant's Address : Turnhoutseweg 30 B-2340 Beerse Belgium
Initial Date of Registration : 2007-05-21
Latest Date of Registration : 2007-05-21
Registration Number : 223MF10006
Registrant's Address : 59, You Shih Road, Youth Industrial District, Dajia, Taichung, Taiwan 43767, R. O. C.
Initial Date of Registration : 2011-01-14
Latest Date of Registration : 2020-05-25
A Miconazole Nitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Miconazole Nitrate, including repackagers and relabelers. The FDA regulates Miconazole Nitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Miconazole Nitrate 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 Miconazole Nitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Miconazole Nitrate supplier is an individual or a company that provides Miconazole Nitrate active pharmaceutical ingredient (API) or Miconazole Nitrate finished formulations upon request. The Miconazole Nitrate suppliers may include Miconazole Nitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Miconazole Nitrate 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 Miconazole Nitrate Drug Master File in Japan (Miconazole Nitrate JDMF) empowers Miconazole Nitrate 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 Miconazole Nitrate JDMF during the approval evaluation for pharmaceutical products. At the time of Miconazole Nitrate 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 Miconazole Nitrate suppliers with JDMF on PharmaCompass.
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