The plant was set up in 2009 to produce oncology treatments in injectable, tablet and softgel dosage forms. Now, having received US Food and Drug Administration (FDA) approval the plant, and Stride Arcolab’s speciality business, will expand operations.
“With this approval and the recently announced approval for the sterile complex, we now look forward to scaling up our specialty business through the launch of highly specialised products for the US market”, said Venkat Iyer, CEO of Agila Specialties, a wholly-owned Strides’ subsidiary.
Strides has filed 31 abbreviated new drug applications (ANDAs) for oncology products and expects to begin receiving approvals now the plant has regulatory clearance. Entering the US oncology market will help Strides’ speciality unit hit its 45 per cent year-on-year growth target.
Other major regulatory authorities have already approved the facility. In Europe, Strides has 18 oncology product filings and has also made submissions in other established and emerging markets.
Strides expects to commercialise its first oncology product in the US in the second half of 2011.
Big pharma deals
Rapid expansion of the speciality business is supported by joint ventures with big pharma. Last year Strides formed, and then expanded, a licensing and supply deal with Pfizer. The deal includes 40 generic products for the US market.
In 2008 Onco Therapies Limited (OTL), a joint venture with Aspen Pharmacare, entered into an out-licensing deal with GlaxoSmithKline for injectable products in 95 emerging markets. OTL operates the newly approved Bangalore plant, which is also used in the GSK deal.
Approval of the OTL-operated plant means all five of Strides’ sterile plants in India have been passed by the FDA.