01 2PolyPeptide Laboratories (Sweden) AB
01 2Desmopressin
01 2Switzerland
Registration Number : 224MF10122
Registrant's Address : Ho(¨)gerudsgatan 21, Limhamn
Initial Date of Registration : 2012-07-09
Latest Date of Registration : 2023-06-28
Registration Number : 306MF10047
Registrant's Address : Ho(¨)gerudsgatan 21, Limhamn
Initial Date of Registration : 2024-03-27
Latest Date of Registration : 2024-03-27
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A 62288-83-9 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 62288-83-9, including repackagers and relabelers. The FDA regulates 62288-83-9 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 62288-83-9 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 62288-83-9 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A 62288-83-9 supplier is an individual or a company that provides 62288-83-9 active pharmaceutical ingredient (API) or 62288-83-9 finished formulations upon request. The 62288-83-9 suppliers may include 62288-83-9 API manufacturers, exporters, distributors and traders.
click here to find a list of 62288-83-9 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 62288-83-9 Drug Master File in Japan (62288-83-9 JDMF) empowers 62288-83-9 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 62288-83-9 JDMF during the approval evaluation for pharmaceutical products. At the time of 62288-83-9 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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