01 1Harman Finochem
01 1FOSPROPOFOL DISODIUM
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35337
Submission : 2020-11-28
Status : Active
Type : II
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PharmaCompass offers a list of Fospropofol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Fospropofol manufacturer or Fospropofol supplier for your needs.
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A Fospropofol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fospropofol, including repackagers and relabelers. The FDA regulates Fospropofol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fospropofol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Fospropofol supplier is an individual or a company that provides Fospropofol active pharmaceutical ingredient (API) or Fospropofol finished formulations upon request. The Fospropofol suppliers may include Fospropofol API manufacturers, exporters, distributors and traders.
click here to find a list of Fospropofol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Fospropofol DMF (Drug Master File) is a document detailing the whole manufacturing process of Fospropofol active pharmaceutical ingredient (API) in detail. Different forms of Fospropofol DMFs exist exist since differing nations have different regulations, such as Fospropofol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fospropofol DMF submitted to regulatory agencies in the US is known as a USDMF. Fospropofol USDMF includes data on Fospropofol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fospropofol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fospropofol suppliers with USDMF on PharmaCompass.
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