01 1Hetero Labs Limited
02 1Sicor S.r.l.
03 1Teva Czech Industries s.r.o
01 3Pralatrexate
01 1India
02 1Israel
03 1Italy
NDC Package Code : 68554-0071
Start Marketing Date : 2009-09-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 53183-4020
Start Marketing Date : 2013-07-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 47848-045
Start Marketing Date : 2013-03-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
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.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Folotyn as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Folotyn API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Folotyn as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Folotyn and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Folotyn NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Folotyn suppliers with NDC on PharmaCompass.
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