01 1Corden Pharma Bergamo SpA
02 1F.I.S. FABBRICA ITALIANA SINTETICI S.P.A.
03 1FLAMMA S.P.A.
01 1TROFINETIDE
02 2Trofinetide
01 3Italy
NDC Package Code : 49964-0102
Start Marketing Date : 2022-12-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 48087-0160
Start Marketing Date : 2022-07-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 54236-120
Start Marketing Date : 2024-06-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Trofinetide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trofinetide, including repackagers and relabelers. The FDA regulates Trofinetide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trofinetide 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 Trofinetide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trofinetide supplier is an individual or a company that provides Trofinetide active pharmaceutical ingredient (API) or Trofinetide finished formulations upon request. The Trofinetide suppliers may include Trofinetide API manufacturers, exporters, distributors and traders.
click here to find a list of Trofinetide 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 Trofinetide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Trofinetide 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 Trofinetide 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 Trofinetide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trofinetide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Trofinetide suppliers with NDC on PharmaCompass.
We have 3 companies offering Trofinetide
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
