01 1Amphastar Nanjing Pharmaceuticals,Inc.
01 1Idraparinux sodium
01 1U.S.A
NDC Package Code : 52221-103
Start Marketing Date : 2014-06-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER, FOR SUSPENSION (1kg/kg)
Marketing Category : BULK INGREDIENT
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A Idraparinux sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Idraparinux sodium, including repackagers and relabelers. The FDA regulates Idraparinux sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Idraparinux sodium 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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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 Idraparinux sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Idraparinux sodium 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 Idraparinux sodium 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 Idraparinux sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Idraparinux sodium NDC to their finished compounded human drug products, they may choose to do so.
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