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