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Glenmark Pharmaceuticals ltd Regulatory Filings 2020

Jun 19, 2020

62608_rns_2020-06-19_62746d6c-1674-4e4e-be03-188d9d392b6f.pdf

Regulatory Filings

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June 19, 2020

To, To, Dy. General Manager The Manager – Listing, Department of Corporate Services, The National Stock Exchange of India Ltd., BSE Ltd., Plot No. C/1, G Block, P. J. Towers, Dalal Street, Bandra Kurla Complex, Fort, Mumbai – 400 001. Bandra (E), Mumbai – 400 051.

Ref: Scrip Code: 532296

Ref: Scrip Name: GLENMARK

Dear Sir,

Sub: Glenmark Pharmaceuticals receives ANDA approval for Fingolimod Capsules, 0.5 mg

With reference to the subject mentioned above, kindly find attached media release which is selfexplanatory.

Request you to kindly take the same on record.

Thanking you,

Yours faithfully,

For Glenmark Pharmaceuticals Limited

HARISH VINAYAK KUBER

Digitally signed by HARISH VINAYAK KUBER DN: c=IN, st=Maharashtra, 2.5.4.20=cde2956f5be913821f9f9f91026d376afdaebf5fb8838c3a71de 2e75255a782d, postalCode=400049, street=C21, Maker Kundan Garden, serialNumber=afdac79f9832ea525179ba4771e8bfb76ef0e3cac49116 0cbf271c80d4b16e4f, o=Personal, cn=HARISH VINAYAK KUBER Date: 2020.06.19 08:47:36 +05'30'

Harish Kuber Company Secretary & Compliance Officer

Encl: as above

Glenmark Pharmaceuticals Ltd. Glenmark House, B D Sawant Marg, Andheri (E), Mumbai 400 099 T: 91 22 4018 9999 F: 91 22 4018 9988 CIN No: L24299MH1977PLC019982 W: www.glenmarkpharma.com Registered office: B/2, Mahalaxmi Chambers, 22 Bhulabhai Desai Road, Mumbai 400 026 E: [email protected]

Press Release For Immediate Release

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Glenmark Pharmaceuticals receives ANDA approval for Fingolimod Capsules, 0.5 mg

Mumbai, India; June 19, 2020: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Fingolimod Capsules, 0.5 mg, the generic version of Gilenya®[1] Capsules, 0.5 mg, of Novartis Pharmaceuticals Corporation.

According to IQVIA[TM] sales data for the 12 month period ending April 2020, the Gilenya® Capsules, 0.5 mg market[2] achieved annual sales of approximately $2.1 billion*.

Glenmark’s current portfolio consists of 164 products authorized for distribution in the U.S. marketplace and 44 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

—End—

About Glenmark Pharmaceuticals Ltd.

Glenmark Pharmaceuticals Ltd. (GPL) is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries. Glenmark’s key therapy focus areas globally are respiratory, dermatology and oncology. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2019). For more information, visit www.glenmarkpharma.com

For more information:

Glenmark Media Contact

Madhurima Gupta Jain Glenmark Pharmaceuticals, Mumbai, India Tel: +91 22 4018 9606

Email: [email protected]

1All brand names and trademarks are the property of their respective owners.

2Market includes brand and all available therapeutic equivalents

*IQVIA[TM] National Sales Perspectives: Retail & Non-Retail, April 2020

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