01 1Johnson & Johnson Innovative Medicine
01 1ALTANSERIN TARTRATE (CODE NO. R 53200)
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5637
Submission : 1984-12-14
Status : Inactive
Type : II
A Altanserin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Altanserin, including repackagers and relabelers. The FDA regulates Altanserin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Altanserin 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 Altanserin supplier is an individual or a company that provides Altanserin active pharmaceutical ingredient (API) or Altanserin finished formulations upon request. The Altanserin suppliers may include Altanserin API manufacturers, exporters, distributors and traders.
click here to find a list of Altanserin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Altanserin DMF (Drug Master File) is a document detailing the whole manufacturing process of Altanserin active pharmaceutical ingredient (API) in detail. Different forms of Altanserin DMFs exist exist since differing nations have different regulations, such as Altanserin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Altanserin DMF submitted to regulatory agencies in the US is known as a USDMF. Altanserin USDMF includes data on Altanserin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Altanserin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Altanserin suppliers with USDMF on PharmaCompass.
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