ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Cilag AG
03 1Divis Laboratories
04 1Fuan Pharmaceutical
05 1GLAND PHARMA LIMITED
06 1Recordati
07 1Shanghai Ziyuan Pharmaceutical
08 1Sun Pharmaceutical Industries Limited
09 1Trifarma
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-03
Pay. Date : 2023-03-30
DMF Number : 37565
Submission : 2023-03-20
Status :
Type : II
A Fosphenytoin Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fosphenytoin Sodium, including repackagers and relabelers. The FDA regulates Fosphenytoin Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fosphenytoin Sodium 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 Fosphenytoin Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fosphenytoin Sodium supplier is an individual or a company that provides Fosphenytoin Sodium active pharmaceutical ingredient (API) or Fosphenytoin Sodium finished formulations upon request. The Fosphenytoin Sodium suppliers may include Fosphenytoin Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Fosphenytoin Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fosphenytoin Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Fosphenytoin Sodium active pharmaceutical ingredient (API) in detail. Different forms of Fosphenytoin Sodium DMFs exist exist since differing nations have different regulations, such as Fosphenytoin Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fosphenytoin Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Fosphenytoin Sodium USDMF includes data on Fosphenytoin Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fosphenytoin Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fosphenytoin Sodium suppliers with USDMF on PharmaCompass.
We have 9 companies offering Fosphenytoin Sodium
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