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