01 1AstraZeneca UK Limited
02 1DOTTIKON EXCLUSIVE SYNTHESIS AG
03 1MAEDA INC
04 1MSN Laboratories Private Limited
05 1Natco Pharma Limited
01 1ACALABRUTINIB
02 1ACALABRUTINIB MALEATE
03 2Acalabrutinib
04 1Acalabrutinib Dihydrate
01 2India
02 1Switzerland
03 1United Kingdom
04 1Blank
NDC Package Code : 60440-0512
Start Marketing Date : 2017-11-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 54864-601
Start Marketing Date : 2022-04-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 54893-0108
Start Marketing Date : 2021-01-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 63850-8113
Start Marketing Date : 2023-11-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 86184-001
Start Marketing Date : 2023-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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A Acalabrutinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acalabrutinib, including repackagers and relabelers. The FDA regulates Acalabrutinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acalabrutinib 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 Acalabrutinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Acalabrutinib supplier is an individual or a company that provides Acalabrutinib active pharmaceutical ingredient (API) or Acalabrutinib finished formulations upon request. The Acalabrutinib suppliers may include Acalabrutinib API manufacturers, exporters, distributors and traders.
click here to find a list of Acalabrutinib 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 Acalabrutinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Acalabrutinib 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 Acalabrutinib 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 Acalabrutinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Acalabrutinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Acalabrutinib suppliers with NDC on PharmaCompass.
We have 4 companies offering Acalabrutinib
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