Hikal completes third US FDA audit in Bangalore
Indian ingredients manufacturer will ramp up new products under validation
Hikal, an Indian manufacturer of active ingredients, intermediates and regulated starting materials has completed its third US FDA audit at its manufacturing facility in Jigani, Bangalore.
These approvals (in June 2004, July 2008 and August 2011) will enable the company to continue to manufacture and supply a range of active pharmaceutical ingredients (APIs) from this facility to the US, European and Japanese markets.
Ashok Anand, president of Hikal’s pharmaceutical division, commented: ‘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.’
Sameer Hiremath, joint managing director of Hikal, added: ‘This approval is a true testimony to the high standards of quality, regulatory compliance and operating standards at our company.’
Hikal is building a new multipurpose API facility at the Jigani site to meet additional demand from its US, European and Japanese customers.
The firm’s manufacturing facilities are located in Mahad and Taloja (Maharashtra), Panoli (Gujarat) and Jigani. Two research centres in Bangalore and Pune (Acoris) supports these plants.
