01 1GLAND PHARMA LIMITED
02 2Wisdom Pharmaceutical
01 3TIROFIBAN HYDROCHLORIDE
01 2China
02 1India
01 2Active
02 1Inactive
01 2Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-05
Pay. Date : 2013-09-12
DMF Number : 23173
Submission : 2009-10-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-12
Pay. Date : 2018-05-25
DMF Number : 32701
Submission : 2018-04-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26942
Submission : 2013-03-14
Status : Inactive
Type : II
A Tirofiban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tirofiban, including repackagers and relabelers. The FDA regulates Tirofiban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tirofiban API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Tirofiban manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tirofiban supplier is an individual or a company that provides Tirofiban active pharmaceutical ingredient (API) or Tirofiban finished formulations upon request. The Tirofiban suppliers may include Tirofiban API manufacturers, exporters, distributors and traders.
click here to find a list of Tirofiban suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tirofiban DMF (Drug Master File) is a document detailing the whole manufacturing process of Tirofiban active pharmaceutical ingredient (API) in detail. Different forms of Tirofiban DMFs exist exist since differing nations have different regulations, such as Tirofiban USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tirofiban DMF submitted to regulatory agencies in the US is known as a USDMF. Tirofiban USDMF includes data on Tirofiban's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tirofiban USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tirofiban suppliers with USDMF on PharmaCompass.
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