Tag: ANDA process

Hatch-Waxman Act Explained: How It Controls Generic Drug Approval and Prices

By Lindsey Smith    On 4 Aug, 2026    Comments (0)

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The Hatch-Waxman Act balances brand-name patent protection with generic drug competition. Learn how the ANDA process, Orange Book, and 180-day exclusivity drive down costs and improve access.

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How Generic Drugs Are Made: The Full Manufacturing Process Explained

By Lindsey Smith    On 22 Mar, 2026    Comments (13)

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Generic drugs are just as effective as brand-name medications but cost 80-85% less. This article explains the full manufacturing process, from bioequivalence testing to FDA-approved production, and how quality is maintained every step of the way.

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