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