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