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