01 1COSMA S.p.A
02 1Hubei Haosun Pharmaceutical Co., Ltd.
03 2Icrom
04 1Blank
01 5AMISULPRIDE
01 1China
02 3Italy
03 1Blank
01 2Active
02 3Inactive
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33911
Submission : 2019-06-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23493
Submission : 2010-01-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31672
Submission : 2017-07-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25523
Submission : 2011-11-24
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12737
Submission : 1997-11-12
Status : Inactive
Type : II
Portfolio PDF
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Corporate PDF
A Amisulpride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amisulpride, including repackagers and relabelers. The FDA regulates Amisulpride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amisulpride 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 Amisulpride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amisulpride supplier is an individual or a company that provides Amisulpride active pharmaceutical ingredient (API) or Amisulpride finished formulations upon request. The Amisulpride suppliers may include Amisulpride API manufacturers, exporters, distributors and traders.
click here to find a list of Amisulpride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amisulpride DMF (Drug Master File) is a document detailing the whole manufacturing process of Amisulpride active pharmaceutical ingredient (API) in detail. Different forms of Amisulpride DMFs exist exist since differing nations have different regulations, such as Amisulpride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amisulpride DMF submitted to regulatory agencies in the US is known as a USDMF. Amisulpride USDMF includes data on Amisulpride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amisulpride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amisulpride suppliers with USDMF on PharmaCompass.
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