01 1Johnson & Johnson Innovative Medicine
01 1TIPIFARNIB (R115777) DRUG SUBSTANCE
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17517
Submission : 2004-07-14
Status : Active
Type : II
A Tipifarnib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tipifarnib, including repackagers and relabelers. The FDA regulates Tipifarnib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tipifarnib 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 Tipifarnib supplier is an individual or a company that provides Tipifarnib active pharmaceutical ingredient (API) or Tipifarnib finished formulations upon request. The Tipifarnib suppliers may include Tipifarnib API manufacturers, exporters, distributors and traders.
click here to find a list of Tipifarnib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tipifarnib DMF (Drug Master File) is a document detailing the whole manufacturing process of Tipifarnib active pharmaceutical ingredient (API) in detail. Different forms of Tipifarnib DMFs exist exist since differing nations have different regulations, such as Tipifarnib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tipifarnib DMF submitted to regulatory agencies in the US is known as a USDMF. Tipifarnib USDMF includes data on Tipifarnib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tipifarnib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tipifarnib suppliers with USDMF on PharmaCompass.
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