USFDA issues warning letter to Sun Pharma Halol facility
The Warning Letter issued by USFDA usually identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.
New Delhi: Drug major Sun Pharma has announced that the company has received a warning letter from the US Food and Drug Administration (USFDA) for its Halol facility which is already under an import alert. The warning letter summarises violations with respect to Current Good Manufacturing Practice (cGMP) regulations, the Mumbai-based company said in a regulatory filing.
Read also: USFDA inspection: Sun Pharma Halol facility listed under import alert
Sun Pharma is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra. The company manufactures and markets a large basket of pharmaceutical formulations covering a broad spectrum of chronic and acute therapies. It includes generics, branded generics, specialty, complex or difficult-to-make technology-intensive products, over-the-counter (OTC), antiretrovirals (ARVs), Active Pharmaceutical Ingredients (APIs), and Intermediates.
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