01 1M/s. Alkem Laboratories Ltd.
02 1M/s. Sun Pharmaceuticals Ltd.
01 1Dalfampridine IH
02 1Dalfampridine USP
01 1WC-0168
02 1WC-0370n
01 2India
Date of Issue : 2022-07-23
Valid Till : 2025-09-05
Written Confirmation Number : WC-0370n
Address of the Firm : Survey No.- 85 to 88, N.H. No.-8, Naugama, At & Post-Mandva, Tal. - Ankleshwar, ...
Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
Address of the Firm : Plot No. 24/2, & 25, Phase -IV, GIDC, Industrial Zone, At & Post - Panoli, Dist....
A Fampridine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fampridine, including repackagers and relabelers. The FDA regulates Fampridine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fampridine 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 Fampridine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fampridine supplier is an individual or a company that provides Fampridine active pharmaceutical ingredient (API) or Fampridine finished formulations upon request. The Fampridine suppliers may include Fampridine API manufacturers, exporters, distributors and traders.
click here to find a list of Fampridine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fampridine written confirmation (Fampridine WC) is an official document issued by a regulatory agency to a Fampridine manufacturer, verifying that the manufacturing facility of a Fampridine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fampridine APIs or Fampridine finished pharmaceutical products to another nation, regulatory agencies frequently require a Fampridine WC (written confirmation) as part of the regulatory process.
click here to find a list of Fampridine suppliers with Written Confirmation (WC) on PharmaCompass.
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