01 1COSMA S.p.A
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
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
A Gliclazide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gliclazide, including repackagers and relabelers. The FDA regulates Gliclazide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gliclazide 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 Gliclazide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gliclazide supplier is an individual or a company that provides Gliclazide active pharmaceutical ingredient (API) or Gliclazide finished formulations upon request. The Gliclazide suppliers may include Gliclazide API manufacturers, exporters, distributors and traders.
click here to find a list of Gliclazide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gliclazide DMF (Drug Master File) is a document detailing the whole manufacturing process of Gliclazide active pharmaceutical ingredient (API) in detail. Different forms of Gliclazide DMFs exist exist since differing nations have different regulations, such as Gliclazide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gliclazide DMF submitted to regulatory agencies in the US is known as a USDMF. Gliclazide USDMF includes data on Gliclazide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gliclazide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gliclazide suppliers with USDMF on PharmaCompass.
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