01 2Astellas Pharma
01 1NILVADIPINE
02 1NILVADIPINE (FK 235,FR 34235)
01 2Japan
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14287
Submission : 1999-07-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6052
Submission : 1985-10-07
Status : Inactive
Type : II
A Nilvadipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nilvadipine, including repackagers and relabelers. The FDA regulates Nilvadipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nilvadipine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Nilvadipine supplier is an individual or a company that provides Nilvadipine active pharmaceutical ingredient (API) or Nilvadipine finished formulations upon request. The Nilvadipine suppliers may include Nilvadipine API manufacturers, exporters, distributors and traders.
click here to find a list of Nilvadipine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nilvadipine DMF (Drug Master File) is a document detailing the whole manufacturing process of Nilvadipine active pharmaceutical ingredient (API) in detail. Different forms of Nilvadipine DMFs exist exist since differing nations have different regulations, such as Nilvadipine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nilvadipine DMF submitted to regulatory agencies in the US is known as a USDMF. Nilvadipine USDMF includes data on Nilvadipine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nilvadipine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nilvadipine suppliers with USDMF on PharmaCompass.
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