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USDMF Filed Active Pharmaceutical Ingredients (APIs) are substances used in the manufacturing of pharmaceutical products that have been submitted to the U.S. Food and Drug Administration (FDA) as part of a Drug Master File (DMF). These APIs are typically derived from chemical synthesis or natural sources and are essential for the efficacy and safety of drug formulations. The DMF provides detailed information about the manufacturing, processing, and packaging of the API, ensuring compliance with regulatory standards.
| Regulatory compliance | FDA approved under USDMF |
| Purity levels | Typically 95% to 99% |
| Form | Powder or crystalline |
| Storage conditions | Cool, dry place, typically 2-8°C |
| Packaging | Sealed containers to maintain stability |
When selecting USDMF Filed APIs, buyers should consider the specific API required for their formulation and ensure it meets the necessary purity and quality standards. It is important to specify the desired regulatory compliance, such as FDA approval, and any specific documentation needed for quality assurance. Additionally, buyers should inquire about the quantities available and any shelf-life considerations to ensure the API meets their production timelines.
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A DMF is a confidential document submitted to the FDA that contains detailed information about the manufacturing of a drug substance.
USDMF ensures that APIs meet FDA regulations, which is crucial for drug safety and efficacy.
Any active pharmaceutical ingredient intended for use in drug formulations can be filed under USDMF.
You can check the FDA's DMF database or request documentation from the supplier.
Purity levels generally range from 95% to 99%, depending on the specific API.
Many suppliers offer samples upon request to verify quality and suitability.