NDC Package Code : 53183-4007
Start Marketing Date : 2019-08-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
A DM4 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DM4, including repackagers and relabelers. The FDA regulates DM4 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DM4 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 DM4 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DM4 supplier is an individual or a company that provides DM4 active pharmaceutical ingredient (API) or DM4 finished formulations upon request. The DM4 suppliers may include DM4 API manufacturers, exporters, distributors and traders.
click here to find a list of DM4 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 DM4 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for DM4 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 DM4 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 DM4 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DM4 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of DM4 suppliers with NDC on PharmaCompass.
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