01 1H. Lundbeck AS
01 1SERTINDOLE BULK DRUG SUBSTANCE
01 1Denmark
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9414
Submission : 1991-11-20
Status : Inactive
Type : II
A Sertindole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sertindole, including repackagers and relabelers. The FDA regulates Sertindole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sertindole 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 Sertindole supplier is an individual or a company that provides Sertindole active pharmaceutical ingredient (API) or Sertindole finished formulations upon request. The Sertindole suppliers may include Sertindole API manufacturers, exporters, distributors and traders.
click here to find a list of Sertindole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sertindole DMF (Drug Master File) is a document detailing the whole manufacturing process of Sertindole active pharmaceutical ingredient (API) in detail. Different forms of Sertindole DMFs exist exist since differing nations have different regulations, such as Sertindole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sertindole DMF submitted to regulatory agencies in the US is known as a USDMF. Sertindole USDMF includes data on Sertindole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sertindole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sertindole suppliers with USDMF on PharmaCompass.
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