01 1Cambrex Karlskoga AB
02 1HETERO LABS LIMITED
01 2Berotralstat Dihydrochloride
01 1India
02 1U.S.A
NDC Package Code : 12651-120
Start Marketing Date : 2021-01-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 68554-0167
Start Marketing Date : 2020-12-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Berotralstat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Berotralstat, including repackagers and relabelers. The FDA regulates Berotralstat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Berotralstat API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Berotralstat supplier is an individual or a company that provides Berotralstat active pharmaceutical ingredient (API) or Berotralstat finished formulations upon request. The Berotralstat suppliers may include Berotralstat API manufacturers, exporters, distributors and traders.
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 Berotralstat as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Berotralstat 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 Berotralstat 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 Berotralstat and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Berotralstat NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Berotralstat suppliers with NDC on PharmaCompass.
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