Shasun Pharmaceuticals completes USFDA inspection at API unit in Tamil Nadu

08 Jul 2014 Evaluate

Shasun Pharmaceuticals, a global pharmaceutical organization offering world class capabilities and facilities has successfully completed both US FDA and Mexican COFEPRIS (Mexican Regulatory Authority) inspection at its API facility at Cuddalore in Tamil Nadu, India. The USFDA audit was held on second week of June 2014 and the Mexican COFEPRIS audit by APIF was held during the last week of June 2014.

On completion of the inspection, the USFDA inspectors concluded that the facility, systems and practices comply with USFDA requirements with minor 483s and on completion of the inspection APIF concluded that Shasun's compliance with current Good Manufacturing Practices (cGMP) are fully met and a formal GMP certificate will be issued by COFEPRIS in due course.

Shasun Pharmaceuticals manufactures active pharmaceutical ingredients (APIs), their intermediates and enteric coating excipients with a significant presence in some key generics. Shasun has created a strong product portfolio, building on its R&D Expertise, regulatory capabilities and multi scale production capacities. It is one of the largest producers of Ibuprofen worldwide.

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