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Strides Arcolab Limited : Strides Arcolab Receives US FDA Nod To Commercialize First Liquid Injectable Product From Its New Facility

11/10/2012 | 09:03pm US/Eastern

Press Release
Wednesday, April 13, 2011

Strides Arcolab Limited, Strides House, Bannerghatta Road, Bangalore - 560076, India

BSE: 532531

NSE: STAR

STRIDES ARCOLAB RECEIVES US FDA NOD TO COMMERCIALIZE

FIRST LIQUID INJECTABLE PRODUCT FROM ITS NEW FACILITY

• First shipments to commence in April 2011

April 13, 2011, Bangalore: Strides Arcolab Limited (Strides) today announced that it has received approval from the US FDA to commercialize the first liquid injection sterile product from the Company's new Sterile Injectable complex in Bangalore. The approved product has been facing prolonged shortage in the USA and approval from the new facility will offer Strides unconstrained capacities to meet the market demand.

With this approval, significant capacity will be released from the existing site enabling

Strides to commercialize additional liquid injectable products.

Strides had earlier announced approval for Vancomycin Injection from its new facility in Bangalore in a lyophilized format and the Company has already started supplies to the US market in March 2011.

Commenting on this development Venkat Iyer, CEO, Agila Specialties, said, "The US FDA approval for the product from the new site will go a long way in ameliorating product shortages in critical therapeutic areas. Two significant product approvals from the new facility augur well for the launch of a series of products in the USA during 2011"

For reasons of confidentiality, the Company is not in a position to disclose the name of the product.

About Agila Specialties

Agila Specialties Private Limited is the specialties unit of Strides Arcolab which was spun off as a separate division post the Company's restructuring in 2009. It is focused on key domains such as oncolytics, penems, pencillins, cephalosporins, ophthalmics, peptides and biosimilars and operates from 7 world class global manufacturing facilities, including one of the largest steriles capacity in India and amongst the largest lyophilization (freeze drying) capacities in the world. Agila's marketing network covers 70 countries and it has partnerships with some of the world's leading pharmaceutical companies for both developed and emerging markets.

About Strides Arcolab Limited

Strides Arcolab, listed on the Bombay Stock Exchange Limited (532531) and National Stock Exchange of India Limited (STAR), is a global pharmaceutical company headquartered in Bangalore, India that develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables.
The company has 14 manufacturing facilities across 6 countries with presence in more than 75 countries in developed and emerging markets. Manufacturing is ably supported by a 350- scientist strong global R&D Centre located in Bangalore.
Additional information is available at the company's website at www.stridesarco.com.

For further information, please contact:

Strides

PR Consultancy

Mr. V.S. Iyer, CEO - Agila
+91 80 66580111
Mr. Kannan. N (Investors)
+91 98450 54745
Melissa Arulappan (Media)
+91 98450 22389
Corporate Voice | Weber Shandwick
Mahesh Nair,
+91 9880376648 maheshn@corvoshandwick.co.in
Hiba Kunil
+91 98807 26372 hiba@corvoshandwick.co.in

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