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