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01 1Axplora
01 1TIROFIBAN HYDROCHLORIDE MONOHYDRATE
01 1Germany
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27293
Submission : 2013-07-03
Status : Active
Type : II
A Tirofiban Hydrochloride Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tirofiban Hydrochloride Monohydrate, including repackagers and relabelers. The FDA regulates Tirofiban Hydrochloride Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tirofiban Hydrochloride Monohydrate 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 Hydrochloride Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tirofiban Hydrochloride Monohydrate supplier is an individual or a company that provides Tirofiban Hydrochloride Monohydrate active pharmaceutical ingredient (API) or Tirofiban Hydrochloride Monohydrate finished formulations upon request. The Tirofiban Hydrochloride Monohydrate suppliers may include Tirofiban Hydrochloride Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Tirofiban Hydrochloride Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tirofiban Hydrochloride Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Tirofiban Hydrochloride Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Tirofiban Hydrochloride Monohydrate DMFs exist exist since differing nations have different regulations, such as Tirofiban Hydrochloride Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tirofiban Hydrochloride Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Tirofiban Hydrochloride Monohydrate USDMF includes data on Tirofiban Hydrochloride Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tirofiban Hydrochloride Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tirofiban Hydrochloride Monohydrate suppliers with USDMF on PharmaCompass.
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