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PRESS RELEASE A lem bic~ - Touching U- s OWi' 1c;J>Y 1st July, 2021, Vadodara, India Alembic Pharmaceuticals announces USFDA Final Approval for Nitrofurantoin Capsules, USP (Macrocrystals), 25 mg, 50 mg and 100 mg. Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (US FDA) for .its Abbreviated New Drug Application (ANDA) for Nitrofurantoin Capsules, USP (Macrocrystals), 25 mg, 50 mg and 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), 'Macrodantin Capsules, 25 mg, 50 mg, and 100 mg, of Alvogen Malta Operations Ltd. Nitrofurantoin capsules, USP (Macrocrystals) is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin Capsules, USP (Macrocrystals), 25 mg, 50 mg and 100 mg have an estimated market 'size of US$ 23 million for twelve months ending March 2021 according to IQVIA. Alembic has a cumulative total of 146 ANDA approvals (128 final approvals and 18 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 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 oft he 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: Email: aia Mitanshu Shah Phone: +91 265 - 3007630 Ajay Kumar Desai Phone: +9J 22 - 306 11681 ALEMBIC PHARMACEUTICALS LiMITED . REGO. OFFICE : ALEMBIC ROAD, VADODARA - 390 003. • TEL : (0265) 2280550, 228081!0. • FA~ i (0265) 2281229. websit~: www.alembicpharmaceuticals.com • E-mail : [email protected] • CIN _: L24230GJ2010Pt C061123

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