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