The European regulatory agency is the last major board to approve the manufacture of tablets and hard gelatine capsules at OTL’s complex in Bangalore, India, which previously manufactured injectables only.
Venkat Iyer, CEO at Agila Specialties, said, “We are delighted with this development as this further consolidates our global strategy of emerging as a leading provider of oncology drugs.
“The approval is also a testimony to the high standards of quality, compliance and containment practices put in place by Strides.”
The Company expects to commercialise 2 products in Europe during Q3 2011, but did not go into details.
In May the FDA approved the Bangalore facility for the US market.