01 1Johnson & Johnson Innovative Medicine
01 1RITANSERIN (CODE NO. R 55667 )
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5624
Submission : 1984-11-23
Status : Inactive
Type : II
A Ritanserin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ritanserin, including repackagers and relabelers. The FDA regulates Ritanserin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ritanserin 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 Ritanserin supplier is an individual or a company that provides Ritanserin active pharmaceutical ingredient (API) or Ritanserin finished formulations upon request. The Ritanserin suppliers may include Ritanserin API manufacturers, exporters, distributors and traders.
click here to find a list of Ritanserin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ritanserin DMF (Drug Master File) is a document detailing the whole manufacturing process of Ritanserin active pharmaceutical ingredient (API) in detail. Different forms of Ritanserin DMFs exist exist since differing nations have different regulations, such as Ritanserin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ritanserin DMF submitted to regulatory agencies in the US is known as a USDMF. Ritanserin USDMF includes data on Ritanserin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ritanserin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ritanserin suppliers with USDMF on PharmaCompass.
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