01 2Bayer AG
01 1BAYPRESS R(NITRENDIPINE)TABLETS 5MG.,10MG.AND 20MG.
02 1NITRENDIPINE, RAW MATERIAL SUB.(TM:BAYPRESS)
01 2Germany
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5905
Submission : 1985-07-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5401
Submission : 1984-06-18
Status : Inactive
Type : II
65
PharmaCompass offers a list of Nitrendipine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Nitrendipine manufacturer or Nitrendipine supplier for your needs.
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PharmaCompass also assists you with knowing the Nitrendipine API Price utilized in the formulation of products. Nitrendipine API Price is not always fixed or binding as the Nitrendipine Price is obtained through a variety of data sources. The Nitrendipine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Nitrendipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitrendipine, including repackagers and relabelers. The FDA regulates Nitrendipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitrendipine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Nitrendipine supplier is an individual or a company that provides Nitrendipine active pharmaceutical ingredient (API) or Nitrendipine finished formulations upon request. The Nitrendipine suppliers may include Nitrendipine API manufacturers, exporters, distributors and traders.
click here to find a list of Nitrendipine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nitrendipine DMF (Drug Master File) is a document detailing the whole manufacturing process of Nitrendipine active pharmaceutical ingredient (API) in detail. Different forms of Nitrendipine DMFs exist exist since differing nations have different regulations, such as Nitrendipine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nitrendipine DMF submitted to regulatory agencies in the US is known as a USDMF. Nitrendipine USDMF includes data on Nitrendipine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nitrendipine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nitrendipine suppliers with USDMF on PharmaCompass.
