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