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