01 1F. I. S. Fabrica Italiana Sintetici S. p. A.
01 1Clotrimazole
01 1Italy
Registration Number : 221MF10167
Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy
Initial Date of Registration : 2009-07-30
Latest Date of Registration : 2023-02-02
A Lotrimin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lotrimin, including repackagers and relabelers. The FDA regulates Lotrimin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lotrimin 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 Lotrimin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lotrimin supplier is an individual or a company that provides Lotrimin active pharmaceutical ingredient (API) or Lotrimin finished formulations upon request. The Lotrimin suppliers may include Lotrimin API manufacturers, exporters, distributors and traders.
click here to find a list of Lotrimin 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 Lotrimin Drug Master File in Japan (Lotrimin JDMF) empowers Lotrimin 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 Lotrimin JDMF during the approval evaluation for pharmaceutical products. At the time of Lotrimin 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 Lotrimin suppliers with JDMF on PharmaCompass.
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