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