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01 1H. Lundbeck AS
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01 1SERTINDOLE BULK DRUG SUBSTANCE
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01 1Denmark
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01 1Inactive
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01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9414
Submission : 1991-11-20
Status : Inactive
Type : II
90
PharmaCompass offers a list of Sertindole API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Sertindole manufacturer or Sertindole supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sertindole manufacturer or Sertindole supplier.
PharmaCompass also assists you with knowing the Sertindole API Price utilized in the formulation of products. Sertindole API Price is not always fixed or binding as the Sertindole Price is obtained through a variety of data sources. The Sertindole Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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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