TAPI offers customized CDMO Solutions for API development and manufacturing services.
01 1TAPI Technology & API Services
02 1Hetero Drugs
01 2PRALATREXATE
01 1India
02 1Israel
01 2Active
01 2Complete
TAPI offers customized CDMO Solutions for API development and manufacturing services.
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 Folotyn manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Folotyn, including repackagers and relabelers. The FDA regulates Folotyn manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Folotyn 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 Folotyn manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Folotyn supplier is an individual or a company that provides Folotyn active pharmaceutical ingredient (API) or Folotyn finished formulations upon request. The Folotyn suppliers may include Folotyn API manufacturers, exporters, distributors and traders.
click here to find a list of Folotyn suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Folotyn DMF (Drug Master File) is a document detailing the whole manufacturing process of Folotyn active pharmaceutical ingredient (API) in detail. Different forms of Folotyn DMFs exist exist since differing nations have different regulations, such as Folotyn USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Folotyn DMF submitted to regulatory agencies in the US is known as a USDMF. Folotyn USDMF includes data on Folotyn's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Folotyn USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Folotyn suppliers with USDMF on PharmaCompass.
We have 2 companies offering Folotyn
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