TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
01 1TAPI Technology & API Services
02 1Hetero Drugs
01 2PRALATREXATE
01 1India
02 1Israel
01 2Active
01 2Complete
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-10
Pay. Date : 2013-07-16
DMF Number : 27298
Submission : 2013-08-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-14
Pay. Date : 2013-07-05
DMF Number : 27232
Submission : 2013-06-19
Status : Active
Type : II
A Pralatrexate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pralatrexate, including repackagers and relabelers. The FDA regulates Pralatrexate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pralatrexate 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 Pralatrexate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pralatrexate supplier is an individual or a company that provides Pralatrexate active pharmaceutical ingredient (API) or Pralatrexate finished formulations upon request. The Pralatrexate suppliers may include Pralatrexate API manufacturers, exporters, distributors and traders.
click here to find a list of Pralatrexate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pralatrexate DMF (Drug Master File) is a document detailing the whole manufacturing process of Pralatrexate active pharmaceutical ingredient (API) in detail. Different forms of Pralatrexate DMFs exist exist since differing nations have different regulations, such as Pralatrexate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pralatrexate DMF submitted to regulatory agencies in the US is known as a USDMF. Pralatrexate USDMF includes data on Pralatrexate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pralatrexate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pralatrexate suppliers with USDMF on PharmaCompass.
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