01 1Bristol Myers Squibb
01 1TIPREDANE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9081
Submission : 1991-04-30
Status : Inactive
Type : II
A Tipredane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tipredane, including repackagers and relabelers. The FDA regulates Tipredane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tipredane 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 Tipredane supplier is an individual or a company that provides Tipredane active pharmaceutical ingredient (API) or Tipredane finished formulations upon request. The Tipredane suppliers may include Tipredane API manufacturers, exporters, distributors and traders.
click here to find a list of Tipredane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tipredane DMF (Drug Master File) is a document detailing the whole manufacturing process of Tipredane active pharmaceutical ingredient (API) in detail. Different forms of Tipredane DMFs exist exist since differing nations have different regulations, such as Tipredane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tipredane DMF submitted to regulatory agencies in the US is known as a USDMF. Tipredane USDMF includes data on Tipredane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tipredane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tipredane suppliers with USDMF on PharmaCompass.
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