Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

STRIDES PHARMA SCIENCE LIMITED Capital/Financing Update 2019

Feb 20, 2019

62616_rns_2019-02-20_71798a1b-09f7-4ecc-bbe0-dfabf64bbdfd.pdf

Capital/Financing Update

Open in viewer

Opens in your device viewer

February 20, 2019

BSE Limited Phiroze Jeejeebhoy Towers, Dalal Street, Mumbai – 400 001

Scrip code: 532531

The National Stock Exchange of India Limited Exchange Plaza , Bandra‐Kurla Complex Bandra (E) Mumbai ‐ 400 051

Scrip code: STAR

Dear Sirs,

Sub: Press Release

Please find attached press release issued by the Company titled:

“Strides receives USFDA approval for Ethosuximide Softgel Capsules”

Thanks and Regards

For Strides Pharma Science Limited

==> picture [128 x 52] intentionally omitted <==

Manjula Ramamurthy Company Secretary

==> picture [85 x 83] intentionally omitted <==

Strides Pharma Science Limited

(Formerly Strides Shasun Limited) CIN: L24230MH1990PLC057062 Corp Off : Strides House, Bilekahalli, Bannerghatta Road, Bangalore - 560 076, India Tel: +91 80 6784 0000 Fax: +91 80 6784 0700 Regd Off : 201, Devavrata, Sector 17, Vashi, Navi Mumbai – 400 703, India Tel: +91 22 2789 2924 / 3199 Fax: +91 22 2789 2942 [email protected]; www.strides.com

Press Release February 20, 2019

Strides receives USFDA approval for Ethosuximide Softgel Capsules

Softgel franchise now comprises of 10 approved products in the US To be launched immediately by Strides Pharma Inc. in the US market

Bangalore, 20 February 2019 Strides Pharma Science Limited (Strides) today announced that its step‐down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Ethosuximide Softgel Capsules USP, 250 mg from the United States Food & Drug Administration (USFDA). The product was approved in the first review cycle by the USFDA in less than 10 months of filing under the GDUFA II regime . The product is a generic version of Zarontin Capsules, 250 mg, of Pfizer Inc.

Strides specializes in softgel domain and is a global leader in the Rx space. Strides now has a large portfolio of softgel products which now comprises of 10 approved products for the US markets along with a strong product pipeline. Ethosuximide Softgel Capsules is part of Strides niche and small volume product portfolio with limited competition in the US market. According to IQVIA MAT data, the US market for Ethosuximide Softgel Capsules USP, 250 mg is approximately US$ 10 Mn. As part of its portfolio maximization strategy, Strides will also commercialize the product in other geographies leveraging its vast footprint in other regulated markets.

The product will be manufactured at flagship facility in Bangalore and will be marketed by Strides Pharma Inc. in the US market.

The company has 86 cumulative ANDA filings with USFDA of which 57 ANDAs have been approved including 13 approvals received in FY 19.

About Ethosuximide Softgel Capsule

Ethosuximide Softgel capsule is an anti‐epileptic medication to control brief, sudden loss of consciousness and uncontrolled jerking movements in children and adults.

About Strides

Strides, listed on the BSE Limited (532531) and National Stock Exchange of India Limited (STAR), is a global pharmaceutical Company headquartered in Bangalore, India. The Company mainly operates in the regulated markets and has an “in Africa for Africa” strategy along with an institutional business to service donor‐funded markets. The Company’s global manufacturing sites are located in India‐ Bangalore (two sites), Pondicherry and Chennai, Singapore, Italy‐ Milan, and Kenya‐ Nairobi. The Company focusses on “difficult to manufacture” products that are sold in over 100 countries. Additional information is available at the Company’s website at www.strides.com

For further information, please contact:

Strides PR Consultancy Badree Komandur, Executive Director ‐ Finance Fortuna PR +91 80 6784 0747 K Srinivas Reddy: +91 90005 27213 [email protected] Investor Relations: Kannan. N: +91 98450 54745 K Priya: +91 95354 25418 Vikesh Kumar: +91 80 6784 0827 [email protected] Sandeep Baid : +91 80 6784 0791 Email: [email protected] Strides Pharma Science Limited (Formerly Strides Shasun Limited) CIN : L24230MH1990PLC057062 Regd. Office: 201, ‘Devavrata’, Sector ‐ 17, Vashi, Navi Mumbai ‐ 400 703 Corp. Office: Strides House, Bannerghatta Road, Bangalore ‐ 560076