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Strides gets first injectable ANDA approval

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Announcement Corporate
Bangalore, India, July 18, 2007: Strides Arcolab Limited today announced its first ANDA (Abbreviated New Drug Application) approval for Keterolac Tromethamine Injection USP, 15 mg/mL and 30 mg/mL.
 
 
The product is licensed to Akorn-Strides, LLC, which is a Joint Venture that was formed in 2004 by Akorn, Inc. (NASDAQ: AKRX) and Strides Arcolab Limited (NSE: STAR, BSE: 532531).
 
 
Ketrolac is the first approval amongst 22 sterile submissions the Company has submitted with US FDA and follows a successful FDA approval of its sterile manufacturing facility in India.
 
 
Arun Kumar "� Vice Chairman and Managing Director of Strides Arcolab stated, "We are excited with our first sterile injectable approval and are delighted having achieved a key milestone in creating a global sterile injectable business'.
 
 
About Strides Arcolab Limited: Strides, listed on the Bombay Stock Exchange Limited (532531) and National Stock Exchange of India Limited (STAR), is one of India's largest exporters of branded generic pharmaceutical products. Strides manufacture pharmaceuticals formulations in various dosage forms, including capsules, tablets, liquid injectables and is one of the world's top five manufacturers of softgel capsules. Strides also have the only globally dedicated soft gel facility for hormones. In addition, Strides undertakes contract research and the manufacturing of specialty chemicals for various multinational companies. Strides has a major presence in various developing countries such as Africa, Latin America and Asia as well as in developed markets such as the US, Canada and part of Europe. Strides is one of the largest Indian suppliers of institutionally funded aid projects and is an approved supplier to the World Bank, the African Development Bank and UNICEF, amongst others.
 
 
Strides has 14 manufacturing plants spread across the US, Brazil, Mexico, Italy, Poland, Singapore and India. This broad manufacturing network facilities partnering with global organizations ranging from UNICEF and WHO-Global Drug Facility to European and American pharmaceutical multinationals and also private labelers and distribution chains. Strides have product registrations in over 37 countries around the world and has earned ISO 9001, ISO 14001 and GMP accreditations including USFDA. Strides employ approximately 1,700 people across the globe. Strides also have a marketing presence in over 50 countries.
 
Additional information is available at the Company's website at www.stridesarco.com.
 
 
 

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First Published: Jul 18 2007 | 12:00 AM IST

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