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