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
A Amoxicillin+Clavulanic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amoxicillin+Clavulanic Acid, including repackagers and relabelers. The FDA regulates Amoxicillin+Clavulanic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amoxicillin+Clavulanic Acid 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 Amoxicillin+Clavulanic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amoxicillin+Clavulanic Acid supplier is an individual or a company that provides Amoxicillin+Clavulanic Acid active pharmaceutical ingredient (API) or Amoxicillin+Clavulanic Acid finished formulations upon request. The Amoxicillin+Clavulanic Acid suppliers may include Amoxicillin+Clavulanic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Amoxicillin+Clavulanic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amoxicillin+Clavulanic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Amoxicillin+Clavulanic Acid active pharmaceutical ingredient (API) in detail. Different forms of Amoxicillin+Clavulanic Acid DMFs exist exist since differing nations have different regulations, such as Amoxicillin+Clavulanic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amoxicillin+Clavulanic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Amoxicillin+Clavulanic Acid USDMF includes data on Amoxicillin+Clavulanic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amoxicillin+Clavulanic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amoxicillin+Clavulanic Acid suppliers with USDMF on PharmaCompass.
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