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Strides Arcolab receives 1st NDA approval from USFDA

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Announcement Companies & Industry
Last Updated : Feb 05 2013 | 12:35 AM IST
Mumbai, India: March 5, 2007: Strides Arcolab Ltd. today announced that it has received tentative approval from the United States Food and Drug Administration for Lamivudine/Zidovudine 150 mg/300 mg Tablets co-packaged with Nevirapine 200 mg Tablets.
 
This is the company's first NDA approval. This application was reviewed under the expedited review provisions of the President's Emergency Plan for Aids Relief [PEPFAR] program.
 
Arun Kumar "� Vice Chairman and Managing Director, Strides Arcolab said "We are pleased to receive our first tentative approval for a NDA from the USFDA. This approval represents a significant opportunity for Strides to commercialize field adaptable fixed dose combination ARVs co-packaged with other ARVs for ease of patient compliance."
 
The company has already received tentative approval from FDA for Stavudine Capsules and Nevirapine Tablets. Four applications are under review with the US FDA under the same program and another 12 are in the pipeline for development and submission. The company has 6 WHO pre-qualified ARVs which are supplied to more than 37 countries in Africa and Asia.
 
The company is also partnering with the Clinton Foundation to ensure availability of affordable quality generic ARVs in least developed countries.
 
About Strides Arcolab
 
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: www.stridesarco.com

 
 

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First Published: Mar 05 2007 | 12:00 AM IST

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