Strides Arcolab gets USFDA nod to commercialise first Sterile product
First shipments to commence in March, 2011
Strides Arcolab Limited (Strides) today announced that it has received approval from the US FDA to commercialise Vancomycin Injection from the company’s new Sterile Injectable complex in Bangalore.
Vancomycin Injection is currently facing a significant upswing in demand in the USA and the approval of this product from the new facility offers Strides unconstrained capacities to meet the increasing demand. The first shipments of Vancomycin Injection to the USA from Strides’ new facility will commence in March, 2011.
Commenting on this significant development, Venkat Iyer, CEO, Agila Specialties, said, “The US FDA approval for the new site is an important milestone in scaling up our business in the USA. With our unconstrained capacity, we are now well positioned to take advantage of the significant opportunity for Injectable products in the US market. We will follow this with a series of initiatives to include the new facility in all the approved ANDAs thereby facilitating the launch of more products in the US in the coming quarters.”
Strides Arcolab 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%.
Background information
- As of December 31, 2010, Strides Arcolab has 113 Injectable ANDA filings and 33 approvals from the US FDA.
- Out of the above approvals, Strides has commercialised only 9 products from its already approved site which absorbs the total capacity available.
- Vancomycin Injection utilises 70% of the current capacities, thereby constraining launch of other approved ANDAs.
- The new approved site has significant unconstrained capacities and shifting production of Vancomycin Injection to the new site will release capacities in the existing site for launching additional approved products.
- A number of approved products will be shifted to the new site following regulatory procedures of site changes which will accelerate the launch of additional already approved products for the USA Market.
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.