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01 1Evonik Rexim S.A.S.
01 1L-Ornithine-L-Aspartate
01 1Germany
NDC Package Code : 51593-5013
Start Marketing Date : 2021-06-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A ornithine aspartate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ornithine aspartate, including repackagers and relabelers. The FDA regulates ornithine aspartate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ornithine aspartate 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 ornithine aspartate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ornithine aspartate supplier is an individual or a company that provides ornithine aspartate active pharmaceutical ingredient (API) or ornithine aspartate finished formulations upon request. The ornithine aspartate suppliers may include ornithine aspartate API manufacturers, exporters, distributors and traders.
click here to find a list of ornithine aspartate 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 ornithine aspartate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ornithine aspartate 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 ornithine aspartate 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 ornithine aspartate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ornithine aspartate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ornithine aspartate suppliers with NDC on PharmaCompass.
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