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