STRIDES PHARMA SCIENCE LIMITED Press Release
Thursday, February 2, 2017
Strides Shasun Limited (Formerly Strides Arcolab Limited) Strides House, Bannerghatta Road,
Bangalore - 560076.
Strides Shasun receives USFDA Tentative Approval for Fingolimod CapsulesSecond FTF Approval For the company
Bangalore, February 2, 2017: Strides Shasun Limited today announced that its subsidiary Strides Pharma Global Pte Limited, Singapore has received tentative approval from the United States Food & Drug Administration (USFDA) for its Para IV filing of Fingolimod Capsules, 0.5 mg. The product can be launched on generic market formation expected in February 2019, with a potential 180 day exclusivity.According to IMS data, the US market for Fingolimod Capsules is approximately USD 2 Bn. Fingolimod Capsules registered a healthy CAGR of 10 % over last 5 years (IMS December 2016 MAT data). Based upon available information, Company believes it is amongst the first wave of ANDA applicants for Fingolimod with a Paragraph IV certification. On receiving full approval, the product will be manufactured at the Company's Oral dosage facility at Bangalore and marketed by its subsidiary in USA, Strides Pharma Inc.
About Fingolimod CapsulesFingolimod Capsules is used for treatment of adult patients with relapsing forms of multiple sclerosis. The product is currently sold by Novartis under the brand name GILENYA®
About Strides Shasun LimitedStrides Shasun, listed on the BSE Limited (532531) and National Stock Exchange of India Limited (STAR), is a vertically integrated global pharmaceutical Company headquartered in Bangalore. The Company has four business verticals, viz., Regulated Markets, Emerging Markets, Institutional Business and Pharmaceutical Services & Active Ingredients.
The Company has global manufacturing foot print with 13 manufacturing facilities spread across three continents including 5 US FDA approved facilities and 8 facilities for the emerging markets. The Company has three dedicated R&D facilities in India with global filing capabilities and a strong commercial footprint across 85 countries Additional information is available at the Company's website at www.stridesarco.com
For further information, please contact:Strides Shasun
Badree Komandur, Group CFO
+91 80 6784 0747
Vikesh Kumar +91 80 6784 0827
Kannan. N: +91 98450 54745
Sandeep Baid: +91 80 6784 0791
PR Consultancy
Fortuna PRK Srinivas Reddy: +91 9000527213 srinivas@fortunapr.com
K Priya: +91 9535425418
priya@fortunapr.com
Strides Arcolab Limited published this content on 02 February 2017 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 06 February 2017 09:52:09 UTC.
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