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