01 1PolyPeptide Laboratories France SAS
01 1Difelikefalin
01 1Switzerland
Registration Number : 304MF10128
Registrant's Address : 7 rue de Boulogne 67100 Strasbourg, France
Initial Date of Registration : 2022-09-08
Latest Date of Registration : 2023-07-19
A Difelikefalin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Difelikefalin, including repackagers and relabelers. The FDA regulates Difelikefalin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Difelikefalin 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 Difelikefalin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Difelikefalin supplier is an individual or a company that provides Difelikefalin active pharmaceutical ingredient (API) or Difelikefalin finished formulations upon request. The Difelikefalin suppliers may include Difelikefalin API manufacturers, exporters, distributors and traders.
click here to find a list of Difelikefalin 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 Difelikefalin Drug Master File in Japan (Difelikefalin JDMF) empowers Difelikefalin 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 Difelikefalin JDMF during the approval evaluation for pharmaceutical products. At the time of Difelikefalin 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 Difelikefalin suppliers with JDMF on PharmaCompass.
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