Hikal's API Manufacturing Site In Bangalore Completes 3rd Successful US FDA Inspection.

Hikal Limited, a leading manufacturer of active ingredients, intermediates and regulated starting materials successfully completed its 3rd US FDA audit at its manufacturing facility located at Jigani, Bangalore.

The 3rd site approval (June 2004, July 2008, August 2011) accorded by the US FDA will enable the company to continue to manufacture and supply a wide range of active pharmaceutical ingredients (APIs) from this facility to its customers in the US, European and Japanese markets.

Commenting on this achievement, Mr Ashok Anand, President of Hikal's pharmaceutical division said "This approval from the US FDA will give us the ability to ramp up our new products under validation and build on our strong position in our existing molecules."

The inspection was carried out at the Jigani, Bangalore site over a period of five days.

"Compliance to current regulatory standards and guidelines is critical for Hikal and its customers. This approval is a true testimony to the high standards of quality, regulatory compliance and operating standards at our company. Our culture of building quality into all we do is continuously reinforced at all our sites and across all levels in the organization. " Sameer Hiremath Joint Managing Director of Hikal said in a press release.

Hikal is building a new multipurpose API facility at this site to meet additional demand from its US, European and Japanese customers.

SOURCE: Hikal