01 1FINECURE PHARMACEUTICALS LTD
01 1FINEMOX CV 625 (CO- AMOXICLAV TABLETS BP 625 MG)
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26966
Submission : 2013-01-29
Status : Active
Type : II
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A Augmentine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Augmentine, including repackagers and relabelers. The FDA regulates Augmentine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Augmentine 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 Augmentine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Augmentine supplier is an individual or a company that provides Augmentine active pharmaceutical ingredient (API) or Augmentine finished formulations upon request. The Augmentine suppliers may include Augmentine API manufacturers, exporters, distributors and traders.
click here to find a list of Augmentine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Augmentine DMF (Drug Master File) is a document detailing the whole manufacturing process of Augmentine active pharmaceutical ingredient (API) in detail. Different forms of Augmentine DMFs exist exist since differing nations have different regulations, such as Augmentine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Augmentine DMF submitted to regulatory agencies in the US is known as a USDMF. Augmentine USDMF includes data on Augmentine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Augmentine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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