Shasun Pharma successfully completes US and Mexican drug regulator inspection

Shasun Pharmaceuticals Ltd., a global pharmaceutical organization, has successfully completed both US Food and Drug Administration (FDA) and Mexican COFEPRIS (Mexican Regulatory Authority) inspection at its API facility at Cuddalore, Tamil Nadu, India.The FDA inspection was held on second week of June 2014 and the Mexican COFEPRIS inspection was held during the last week of June 2014.

The US FDA inspectors concluded that the facility, systems and practices comply with US FDA requirements with minor 483s upon completion of the inspection. In addition, Mexican authorities concluded the facility compliant with current Good Manufacturing Practices (cGMP) and a formal GMP certificate will be issued by COFEPRIS in due course. According to credit rating agency Crisil, Indian drugmakers have started double spending on compliance over the past 5 years after rising recognition of FDA scrutiny and the cost of quality failings.

Shasun Pharmaceuticals Ltd is a leading manufacturer of APIs and formulations, catering to global customers, with world class capabilities and facilities. Shasun offers formulation and generic manufacturing services at its Indian sites together with a contract research and manufacturing services for APIs in India and UK.