Wednesday, April 13, 2011
Strides Arcolab Limited, Strides House, Bannerghatta Road, Bangalore - 560076, India
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:
Mr. V.S. Iyer, CEO - Agila
+91 80 66580111
Mr. Kannan. N (Investors)
+91 98450 54745
Melissa Arulappan (Media)
+91 98450 22389
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+91 9880376648 [email protected]
+91 98807 26372 [email protected]