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