01 1Cambrex Karlskoga AB
02 1Natco Pharma Limited
03 1Zhejiang Lepu Pharmaceutical Co., Ltd.
01 3Idelalisib
01 1China
02 1India
03 1U.S.A
NDC Package Code : 12651-122
Start Marketing Date : 2016-06-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 63850-8098
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 : 68578-0013
Start Marketing Date : 2018-05-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (7kg/1)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
A Idelalisib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Idelalisib, including repackagers and relabelers. The FDA regulates Idelalisib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Idelalisib 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 Idelalisib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Idelalisib supplier is an individual or a company that provides Idelalisib active pharmaceutical ingredient (API) or Idelalisib finished formulations upon request. The Idelalisib suppliers may include Idelalisib API manufacturers, exporters, distributors and traders.
click here to find a list of Idelalisib 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 Idelalisib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Idelalisib 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 Idelalisib 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 Idelalisib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Idelalisib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Idelalisib suppliers with NDC on PharmaCompass.
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