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 Salbutamol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Salbutamol, including repackagers and relabelers. The FDA regulates Salbutamol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Salbutamol 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 Salbutamol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Salbutamol supplier is an individual or a company that provides Salbutamol active pharmaceutical ingredient (API) or Salbutamol finished formulations upon request. The Salbutamol suppliers may include Salbutamol API manufacturers, exporters, distributors and traders.
click here to find a list of Salbutamol 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 Salbutamol Drug Master File in Japan (Salbutamol JDMF) empowers Salbutamol 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 Salbutamol JDMF during the approval evaluation for pharmaceutical products. At the time of Salbutamol 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 Salbutamol suppliers with JDMF on PharmaCompass.
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