01 1ALP Pharm
01 1SULPIRIDE EP
01 1China
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20209
Submission : 2007-01-05
Status : Inactive
Type : II
A Sulpiride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulpiride, including repackagers and relabelers. The FDA regulates Sulpiride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulpiride 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 Sulpiride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sulpiride supplier is an individual or a company that provides Sulpiride active pharmaceutical ingredient (API) or Sulpiride finished formulations upon request. The Sulpiride suppliers may include Sulpiride API manufacturers, exporters, distributors and traders.
click here to find a list of Sulpiride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sulpiride DMF (Drug Master File) is a document detailing the whole manufacturing process of Sulpiride active pharmaceutical ingredient (API) in detail. Different forms of Sulpiride DMFs exist exist since differing nations have different regulations, such as Sulpiride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sulpiride DMF submitted to regulatory agencies in the US is known as a USDMF. Sulpiride USDMF includes data on Sulpiride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sulpiride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sulpiride suppliers with USDMF on PharmaCompass.
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