01 1Cambrex Profarmaco Milano S. r. l.
01 1Salbutamol sulphate
01 1U.S.A
Registration Number : 219MF10285
Registrant's Address : Via Curiel 34, 20067 Paulo, Milano, ITALY
Initial Date of Registration : 2007-09-10
Latest Date of Registration : 2020-06-11
A Fartolin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fartolin, including repackagers and relabelers. The FDA regulates Fartolin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fartolin 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 Fartolin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fartolin supplier is an individual or a company that provides Fartolin active pharmaceutical ingredient (API) or Fartolin finished formulations upon request. The Fartolin suppliers may include Fartolin API manufacturers, exporters, distributors and traders.
click here to find a list of Fartolin 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 Fartolin Drug Master File in Japan (Fartolin JDMF) empowers Fartolin 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 Fartolin JDMF during the approval evaluation for pharmaceutical products. At the time of Fartolin 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 Fartolin suppliers with JDMF on PharmaCompass.
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