01 1PolyPeptide Laboratories (Sweden) AB
01 1Felypressin
01 1Switzerland
Registration Number : 220MF10039
Registrant's Address : Ho(¨)gerudsgatan 21, Limhamn
Initial Date of Registration : 2008-02-05
Latest Date of Registration : 2008-02-05
A Felypressin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Felypressin, including repackagers and relabelers. The FDA regulates Felypressin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Felypressin 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 Felypressin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Felypressin supplier is an individual or a company that provides Felypressin active pharmaceutical ingredient (API) or Felypressin finished formulations upon request. The Felypressin suppliers may include Felypressin API manufacturers, exporters, distributors and traders.
click here to find a list of Felypressin 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 Felypressin Drug Master File in Japan (Felypressin JDMF) empowers Felypressin 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 Felypressin JDMF during the approval evaluation for pharmaceutical products. At the time of Felypressin 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 Felypressin suppliers with JDMF on PharmaCompass.
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