Cosma S.p.A., part of CFM Group with AMSA & Clarochem, provides global pharma & veterinary health with 300+ tons of FDA-approved APIs.
01 1Cosma (C.F.M. Group)
02 1NINGBO DOUBLE SUN PHARMACEUTICAL CO LTD
03 1SHANDONG FANGMING PHARMACEUTICAL GROUP C
01 3GLICLAZIDE
01 2China
02 1Italy
01 1Active
02 2Inactive
01 3Blank
Cosma S.p.A., part of CFM Group with AMSA & Clarochem, provides global pharma & veterinary health with 300+ tons of FDA-approved APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25538
Submission : 2011-12-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19921
Submission : 2006-08-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25574
Submission : 2011-11-30
Status : Inactive
Type : II
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A Diamicron MR manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diamicron MR, including repackagers and relabelers. The FDA regulates Diamicron MR manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diamicron MR API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Diamicron MR supplier is an individual or a company that provides Diamicron MR active pharmaceutical ingredient (API) or Diamicron MR finished formulations upon request. The Diamicron MR suppliers may include Diamicron MR API manufacturers, exporters, distributors and traders.
click here to find a list of Diamicron MR suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Diamicron MR DMF (Drug Master File) is a document detailing the whole manufacturing process of Diamicron MR active pharmaceutical ingredient (API) in detail. Different forms of Diamicron MR DMFs exist exist since differing nations have different regulations, such as Diamicron MR USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Diamicron MR DMF submitted to regulatory agencies in the US is known as a USDMF. Diamicron MR USDMF includes data on Diamicron MR's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diamicron MR USDMF is kept confidential to protect the manufacturer’s intellectual property.
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