Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
01 1Seqens
02 1Alkem Laboratories
03 1Aurobindo Pharma Limited
04 1Enaltec Labs Private Limited
05 1Industriale Chimica
06 1Intas Pharmaceuticals
07 1Jubilant Generics
08 1Micro Labs Limited
09 1Procos
10 1Regis Technologies
11 1SIGMA TAU
12 1Sun Pharmaceutical Industries Limited
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17860
Submission : 2004-11-29
Status :
Type : II
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 DMF (Drug Master File) is a document detailing the whole manufacturing process of Fampridine active pharmaceutical ingredient (API) in detail. Different forms of Fampridine DMFs exist exist since differing nations have different regulations, such as Fampridine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fampridine DMF submitted to regulatory agencies in the US is known as a USDMF. Fampridine USDMF includes data on Fampridine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fampridine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fampridine suppliers with USDMF on PharmaCompass.
We have 12 companies offering Fampridine
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