Strides Arcolab announces US FDA approval for its Italian Semi-solids and Oinment facility
September 18, 2013: Strides Arcolab Limited (BSE: 532531, NSE: STAR) today announced that it has received US FDA approval for Beltapharm's facility at Milan, Italy. This state-of-the-art, EU and TGA (Australia) approved facility located in Milan, Italy, manufactures liquids, semi-solids, ointments and creams. The Company is expecting its first approval of a niche semisolid product by Q1 2014.
Commenting on the event, Manish Gupta, CEO – Pharma said, "This approval provides further impetus to our Pharma business and marks our foray into the attractive but complex semi-solid market in US. Our first product, which is expected to be commercialized by Q1 2014, has undergone extensive clinical trials. The product will be marketed by one of the top 10 generic companies in US market ".
Strides is developing a portfolio of liquids and semi-solids products for the US and EU markets and currently has over 12 products at various stages of development/approvals. Strides already sells semi-solids in the UK market.
About Beltapharm S.p.A
Beltapharam S.p.A., Italy, a subsidiary of Strides Arcolab Limited (Strides) was acquired by Strides in the year 2006. The facility is part of the retained Pharma Business of Strides Arcolab and manufactures liquids, semi-solids, ointments and creams. The facility is approved by the regulatory authorities of US, EU and Australia. It is also approved by UNICEF and Clinton Foundation for supplies under their program.
Strides Arcolab Limited,
Bangalore – 560076, India
Wednesday, September 18, 2013
About Strides Arcolab
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 IPled 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. Manish Gupta, CEO - Pharma
+91 80 6784 0112
Mr. Kannan N: +91 98450 54745
Kaveri Mandanna: +91 90089 59697
Mahesh Nair: +91 98803 76648