01 1Novartis Pharmaceuticals Corporation
01 1alpelisib
01 1Switzerland
NDC Package Code : 0078-1364
Start Marketing Date : 2022-04-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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PharmaCompass offers a list of Alpelisib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Alpelisib manufacturer or Alpelisib supplier for your needs.
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A 08W5N2C97Q manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 08W5N2C97Q, including repackagers and relabelers. The FDA regulates 08W5N2C97Q manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 08W5N2C97Q API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 08W5N2C97Q supplier is an individual or a company that provides 08W5N2C97Q active pharmaceutical ingredient (API) or 08W5N2C97Q finished formulations upon request. The 08W5N2C97Q suppliers may include 08W5N2C97Q API manufacturers, exporters, distributors and traders.
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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 08W5N2C97Q as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 08W5N2C97Q 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 08W5N2C97Q 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 08W5N2C97Q and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 08W5N2C97Q NDC to their finished compounded human drug products, they may choose to do so.
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