Application made to the FDA for a generic version of a branded drug. The duplicate drug must be bioequivalent to the branded version of the drug. The first company to receive FDA approval of an ANDA receives 180 days of market exclusivity for the generic drug. Compare with NDA.
Glossary
Abbreviated New Drug Application (ANDA)
02.27.12
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APIs | Cytotoxics and High Potency Manufacturing | Formulation Development | Process Development
Solubility Enhancement of Hydrophobic Drugs and APIs Using Hot Melt Extrusion
Efficient processing and production technology for solid molecular dispersion, HME can provide sustained, modified and targeted drug delivery.Ameya Deshpande, Formulation Scientist, Avomeen
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Breaking News | Industry News
ANI Acquires Branded Products Portfolio from Sandoz
Enter multi-year manufacturing and supply agreement.Charles Sternberg, Assistant Editor
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Breaking News | Industry News
ANI Pharmaceuticals Strengthens CDMO Business
Acquisition of Novitium Pharma for $163.5 million also bolsters R&D engine and generics portfolio.Tim Wright, Editor, Contract Pharma
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Breaking News | Industry News
Generic Version of Symbicort Granted FDA Approval
Product is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).Charles Sternberg, Assistant Editor
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Scale-up/Technology Transfer
Ensuring Quality During the Transfer and Scale Up of Rx Drugs
Defining the key parameters and considerations for a successful technology transfer.Tom Chang, President, Bora Pharmaceutical Laboratory Co. Ltd.
