01 1Dipharma Francis S. r. l.
02 1Rolabo Outsourcing,S. L.
03 1Signa S. A. de C. V.
01 3Pirfenidone
01 1Italy
02 1Mexico
03 1Spain
Registration Number : 231MF10023
Registrant's Address : Via Bissone, 5, 20021-Baranzate, Milano, Italy
Initial Date of Registration : 2019-02-05
Latest Date of Registration : 2019-02-05
Registration Number : 231MF10003
Registrant's Address : Poligono Industrial Malpica C/J, No. :3-4 50016 Zaragoza, Spain
Initial Date of Registration : 2019-01-10
Latest Date of Registration : 2019-01-10
Registration Number : 220MF10130
Registrant's Address : Av. Industria Automotriz No 301, Zona Industrial Toluca, Toluca, Estado de Mexico, C....
Initial Date of Registration : 2008-05-20
Latest Date of Registration : 2024-08-28
A Pirfenidone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pirfenidone, including repackagers and relabelers. The FDA regulates Pirfenidone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pirfenidone 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 Pirfenidone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pirfenidone supplier is an individual or a company that provides Pirfenidone active pharmaceutical ingredient (API) or Pirfenidone finished formulations upon request. The Pirfenidone suppliers may include Pirfenidone API manufacturers, exporters, distributors and traders.
click here to find a list of Pirfenidone 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 Pirfenidone Drug Master File in Japan (Pirfenidone JDMF) empowers Pirfenidone 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 Pirfenidone JDMF during the approval evaluation for pharmaceutical products. At the time of Pirfenidone 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 Pirfenidone suppliers with JDMF on PharmaCompass.
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