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