01 1Rhodia Organique SAS
01 1CEP-701
01 1France
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12761
Submission : 1997-11-20
Status : Inactive
Type : II
A Lestaurtinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lestaurtinib, including repackagers and relabelers. The FDA regulates Lestaurtinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lestaurtinib 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 Lestaurtinib supplier is an individual or a company that provides Lestaurtinib active pharmaceutical ingredient (API) or Lestaurtinib finished formulations upon request. The Lestaurtinib suppliers may include Lestaurtinib API manufacturers, exporters, distributors and traders.
click here to find a list of Lestaurtinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lestaurtinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Lestaurtinib active pharmaceutical ingredient (API) in detail. Different forms of Lestaurtinib DMFs exist exist since differing nations have different regulations, such as Lestaurtinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lestaurtinib DMF submitted to regulatory agencies in the US is known as a USDMF. Lestaurtinib USDMF includes data on Lestaurtinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lestaurtinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lestaurtinib suppliers with USDMF on PharmaCompass.
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