81h December, 2021, Vadodara, India

PRESS RELEASE 81h December, 2021, Vadodara, India Alembic Pharmaceuticals receives USFDA Tentative Approval for Selexipaa Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg, and 1,600 mcg. Alembic Pharmaceuticals Limited (Alembic) today announced that the Company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg, and 1,600 mcg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Uptravi Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 nicg, and 1,600 mcg, of Actelion Pharmaceuticals, Ltd. (Actelion). Selexipag Tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression and reduce the risk of hospitalization for PAH. Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg, and 1,600 mcg have an estimated market size of US$ 461 million for twelve months ending September 2021 according to IQVIA. Alembic has received year to date (YTD) 15 approvals (11 final approvals and 4 tentative approvals) and a cumulative total of 154 ANDA 'approvals (134 final approvals arid 20 tentative approvals) from USFDA. About Alembic Pharmaceuticals Limited Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. · Headquartered in India, Alembic is a publicly listed company that r:nanufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic's brands, marketed through a marketing team of over 5000 are well. recognized by doctors and patients. · Information about Alembic can be found at http://www.alembicpharmaceuticals.com/; . (Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLL TD) (BSE: 533573) For more information contact: Ajay Kumar Desai Phone: +91 22 - 306 11681 Mitanshu Shah Phone: +91 265 - 6637630 Email: aia alembic.co.in alembic.co.in ALEMBIC PHARMACEUTICALS LIMITED . REGO. OFFICE: ALEMBIC ROAD, VADODARA • 390 003. •TEL: (0265) 2280550, 2280~ 0. • FAX : (0265) 2281229 website: www.alemblcpharmaceutlcals.com • E-mail : [email protected] • CIN _: L24230GJ2010PLCOS1123

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