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FDA warns Granules India over manufacturing issues, potentially affecting new product approvals.
The U.S. FDA has issued a warning letter to Granules India's facility in Gagillapur, Hyderabad, due to violations of good manufacturing practices.
This could temporarily affect the approval process for new products from this site.
The company is addressing the issues raised and continues to operate without disruptions, aiming to resolve the warning letter within a reasonable timeframe.
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La FDA advierte a Granules India sobre problemas de fabricación, afectando potencialmente a nuevas aprobaciones de productos.