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