01 1MSN Laboratories Private Limited
02 1Sterling Pharma Solutions Limited
01 2Dabrafenib Mesylate
01 1India
02 1United Kingdom
NDC Package Code : 54893-0052
Start Marketing Date : 2016-10-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 50384-6600
Start Marketing Date : 2023-07-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
A Dabrafenib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dabrafenib, including repackagers and relabelers. The FDA regulates Dabrafenib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dabrafenib 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 Dabrafenib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dabrafenib supplier is an individual or a company that provides Dabrafenib active pharmaceutical ingredient (API) or Dabrafenib finished formulations upon request. The Dabrafenib suppliers may include Dabrafenib API manufacturers, exporters, distributors and traders.
click here to find a list of Dabrafenib 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 Dabrafenib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dabrafenib 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 Dabrafenib 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 Dabrafenib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dabrafenib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dabrafenib suppliers with NDC on PharmaCompass.
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