01 1DARMERICA, LLC
01 1Tranilast
01 1U.S.A
NDC Package Code : 71052-463
Start Marketing Date : 2020-11-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (10g/10g)
Marketing Category : BULK INGREDIENT
A Tranilast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tranilast, including repackagers and relabelers. The FDA regulates Tranilast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tranilast 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 Tranilast manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tranilast supplier is an individual or a company that provides Tranilast active pharmaceutical ingredient (API) or Tranilast finished formulations upon request. The Tranilast suppliers may include Tranilast API manufacturers, exporters, distributors and traders.
click here to find a list of Tranilast 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 Tranilast as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tranilast 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 Tranilast 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 Tranilast and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tranilast NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tranilast suppliers with NDC on PharmaCompass.
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