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01 2TRAGARA PHARMACEUTICALS INC
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01 1CS-706 DRUG PRODUCT
02 1CS-706 DRUG SUBSTANCE
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01 2U.S.A
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01 2Inactive
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01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16238
Submission : 2002-11-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16226
Submission : 2002-11-04
Status : Inactive
Type : II
A Apricoxib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Apricoxib, including repackagers and relabelers. The FDA regulates Apricoxib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Apricoxib 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 Apricoxib supplier is an individual or a company that provides Apricoxib active pharmaceutical ingredient (API) or Apricoxib finished formulations upon request. The Apricoxib suppliers may include Apricoxib API manufacturers, exporters, distributors and traders.
click here to find a list of Apricoxib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Apricoxib DMF (Drug Master File) is a document detailing the whole manufacturing process of Apricoxib active pharmaceutical ingredient (API) in detail. Different forms of Apricoxib DMFs exist exist since differing nations have different regulations, such as Apricoxib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Apricoxib DMF submitted to regulatory agencies in the US is known as a USDMF. Apricoxib USDMF includes data on Apricoxib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Apricoxib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Apricoxib suppliers with USDMF on PharmaCompass.
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