01 1Ipca Laboratories
02 1Unichem Laboratories Limited
01 2BENDROFLUMETHIAZIDE USP
01 2India
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19857
Submission : 2006-11-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15847
Submission : 2002-02-04
Status : Active
Type : II
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A Aprinox manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aprinox, including repackagers and relabelers. The FDA regulates Aprinox manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aprinox 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 Aprinox manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Aprinox supplier is an individual or a company that provides Aprinox active pharmaceutical ingredient (API) or Aprinox finished formulations upon request. The Aprinox suppliers may include Aprinox API manufacturers, exporters, distributors and traders.
click here to find a list of Aprinox suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Aprinox DMF (Drug Master File) is a document detailing the whole manufacturing process of Aprinox active pharmaceutical ingredient (API) in detail. Different forms of Aprinox DMFs exist exist since differing nations have different regulations, such as Aprinox USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aprinox DMF submitted to regulatory agencies in the US is known as a USDMF. Aprinox USDMF includes data on Aprinox's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aprinox USDMF is kept confidential to protect the manufacturer’s intellectual property.
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