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Strides Arcolab gets US FDA nod for Oncology facility in Bangalore

India Infoline News Service | Mumbai | May 02, 2011 10:14 IST

Consequent to the approval,Strides expects tobegin receiving ANDA approvals for oncology products for which filings have already been made.

Onco Therapies Limited (OTL), a division of Agila (a wholly owned subsidiary of Strides Arcolab Limited, Strides) has announced that it has received approval from the US FDA for its Oncology facility in Bangalore, a much awaited decision that will enable Strides to play a more significant role in the global oncology industry.Consequent to the approval,Strides expects tobegin receiving ANDA approvals for oncology products for which filings have already been made.

Commenting on this milestoneachievement, Venkat Iyer, CEO, Agila Specialties, said, This approval is a testimony to the high standards of quality, compliance and containment practices put in place by Strides. With this approval and the recently announced approval for the Sterile Complex, we now look forward to scaling up our specialty business throughthe launch of highly specialised products for the US market.

With a world-class sterile injectables platform, robust product pipeline and record regulatory filings, hi-tech manufacturing capacities across countries, an impeccable record of quality and marquee customers and partners across the healthcare industry, the specialty business of Strides is well positioned to build a distinct identity for itself in the industry. Strategic partnerships with the big pharmacompanies including Pfizer and GlaxoSmithKline, continuing licensing income and new product launches in regulated markets have been key growth drivers for the Company.

This approval is an important step in strengthening our specialty business and intent to be a global sterile powerhouse, said Arun Kumar, Vice Chairman & Group CEO, Strides Arcolab. It is a matter of great pride for all of us at Strides and a significant achievement for the Indian pharmaceutical industry, he added.

The state-of-the-art Oncology facility which was established in 2009 manufactures injectables, oral products (tablets and softgels) in the oncology domain. It has been built to the most exacting standards, meeting the requirements of regulatory authorities in the most stringent global markets and is already approved by all other major regulatory authorities allowing the Company to sell globally.

The Company has recently announced US FDA approval for its Sterile Facility (non-oncology) in Bangalore.With these approvals, all of Strides 5 sterile plants in India are now US FDA approved.

The Company reaffirms its guidance for Year 2011 which factors an aggressive growth of 25% over the previous year, with the Specialties business guided to grow at 45%.


Global Partnerships from this Facility:

In January 2010, the Company announced a licensing and supply collaboration with Pfizer Inc for 40 generic products for the US market. The Company expects to commercialize its first Oncology product for the US market in the beginning of H2 2011.

In May 2010, the partnership with Pfizer Inc was strengthened by extending the Oncology agreement to Europe, Canada, Australia, New Zealand, Japan and Korea for 38 generic oncology products.

In July 2008, the Company announced an out-licensing deal between OTL and GlaxoSmithKline Pharma for licensing and supply of Injectable products for the 95 emerging markets. The Oncology products for this partnership will be manufactured from the newly approved plant.

The local market value of the products under Strides partnership with these big pharmacompanies is estimated at USD 20 Billion.

Oncology Regulatory Updates

The Company has already filed 31 Oncology ANDAs (with a local market value of USD 4 Billion) for US FDA approval from this facility.

In Europe, there are 18 Oncology product filings with a local market value of more than USD 3.2 Billion. In addition, the Company has made significant filings in other established and emerging markets.

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