Axplora- The partner of choice for complex APIs.
01 1Farmabios S. p. A.
02 1Sicor Societa (') Italiana Corticosteroidi S. r. l.
01 1Difluprednate
02 1Difluprednate "Teva"
01 1Germany
02 1Italy
Axplora- The partner of choice for complex APIs.
Registration Number : 301MF10046
Registrant's Address : Via Pavia, 1-27027 Gropello Cairoli, Pavia, Italy
Initial Date of Registration : 2019-08-20
Latest Date of Registration : 2019-08-20
Registration Number : 218MF10458
Registrant's Address : Piazzale Luigi Cadorna, 4 - 20123 MILANO, Italy
Initial Date of Registration : 2006-04-27
Latest Date of Registration : 2006-04-27
A Difluprednate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Difluprednate, including repackagers and relabelers. The FDA regulates Difluprednate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Difluprednate 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 Difluprednate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Difluprednate supplier is an individual or a company that provides Difluprednate active pharmaceutical ingredient (API) or Difluprednate finished formulations upon request. The Difluprednate suppliers may include Difluprednate API manufacturers, exporters, distributors and traders.
click here to find a list of Difluprednate 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 Difluprednate Drug Master File in Japan (Difluprednate JDMF) empowers Difluprednate 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 Difluprednate JDMF during the approval evaluation for pharmaceutical products. At the time of Difluprednate 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 Difluprednate suppliers with JDMF on PharmaCompass.
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