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Amneal Pharmaceuticals announced a USD 200 million investment in two Gujarat-based facilities in October 2024

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Cited violations included sameness claims equating compounded products with approved brands and trademarked marketing that obscured the actual compounding source and responsibilities

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From late 2022 through early 2025, widespread supply constraints prompted the FDA to permit compounding under Sections 503A and 503B of the Food, Drug, and Cosmetic Act