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