Press Release Aleor USFDA Final Approval Mupirocin Cream USP, 2%.

PRESS RELEASE · Alem bic~ - - Touching live s ov.r 1@]7 17 th November, 2021, Vadodara, India Alembic Pharmaceuticals announces its joint venture Aleor Dermaceuticals receives USFDA Final Approval for Mupirocin Cream USP, 2%. Alembic Pharmaceuticals Limited (Alembic) today announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Mupirocin Cream USP, 2%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bactroban Cream, 2%, of SmithKline Beecham(Cork) Ltd, Ireland (SmithKline). Mupirocin Cream USP, 2% is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible . strains of S. aureus and S. pyogenes. Aleor has been granted a Competitive Generic Therapies (CGT) designation for this ANDA and it is eligible for 180 days of CGT exclusivity as it is the first approved applicant. Mupirocin Cream USP, 2% has an estimated market size of US$ 28 million for twelve months ending Jun 2021 according to IQVIA. Alembic has received year to date (YTD) 13 approvals (10 final ·approvals and 3 tentative approvals) and a cumulative total of 152 ANDA approvals (133 final approvals and 19 tentative approvals) from USFDA. About Alembic Pharmaceuticals Limited Alembic Pharmaceuticals Limited, a vertically integrated· research and development pharmaceutical company, has been at the forefronto f healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures 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 the company can be found at http://www.alembicpharmaceuticals.com/; (Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLL TD) (BSE: 533573). . About Aleor Dermaceuticals Limited Aleor is a 60:40 joint venture between Alembic and Orbicular Pharmaceutical Technologies Pvt Ltd (Orbicular) formed in Apr'16 focusing on commercialisinq dermatology products globally. For more information contact: Ajay Kumar Desai Phone: +91 22 - 306 11681 Mitanshu Shah Phone: +91 265 - 6637630 Email: mitanshu.shah alembic.co.in ALEMBIC PHARMACEUTICALS LiMITED REGO. OF,FICE : ALEMBIC ROAD, VADODARA • 390 003. •TEL: (0265) 2280550, 228081:!0. • FAX : (0265) 2281229 websltEt : www.alemblcpharmaceutlcals.com • E-mail : [email protected] • CIN : L24230GJ2010PLC061123

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