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Breakthrough! Xianju Pharmaceutical’s formulation product receives its first FDA approval in the United States

Drug Name: Prednisolone Tablets
ANDA Number: 218083
Dosage Form: Tablet
Strength: 5 mg

Prednisolone Tablets are a glucocorticoid. Supraphysiological amounts of glucocorticoids have various pharmacological effects, including anti-inflammatory, anti-allergic, and immunosuppressive actions. They are primarily used for allergic and autoimmune inflammatory diseases, as well as collagen diseases.

This is the first finished dosage form product from Xianju Pharmaceutical to receive FDA approval, marking the company’s qualification to market this product in the U.S. market. It will help the company gain regulatory experience in exploring and expanding the international generic drug market and have a positive impact.

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