22nd November, 2019, Vadodara, India
2019-11-01 · Alembic Pharmaceuticals Ltd. · original alembicpharmaceuticals.com ↗
PRESS RELEASE 22nd November, 2019, Vadodara, India Alembic Pharmaceuticals receives USFDA Approvals Alembic Pharmaceuticals Limited today announced that the Company has received approval from US Food & Drug Administration (USFDA) for its following Abbreviated New Drug Applications (ANDAs): USFDA Name of Dosage Equivalent to Usage Estimated Approval the ANDAs reference listed drug Market Size product (RLD) Final Deferasirox 90 mg Jadenu Tablets, 90 mg Treatment of US$ 415 Tablets and 360 and 360 mg, of Novartis chronic iron million for mg Pharmaceuticals overload due twelve months Corporation (Novartis). to blood ending transfusions in December patients 2 2018 ' years of age according to and older. IQVIA. Final Deferasirox 125 mg, Exjade Tablets for Oral Same as US$ 135 Tablets for 250 mg, Suspension, 125 mg, above. million for Oral and 500 250 mg, and 500 mg, of twelve months Suspension mg Novartis ending Pharmaceuticals December Corporation (Novartis). 2018 according to IQVIA. Tentative Deferasirox 180 mg Jadenu Tablets, 180 Same as US$59 million Tablets mg, of Novartis above. for twelve Pharmaceuticals months ending Corporation (Novartis). December 2018 according to IQVIA. Alembic now has a total of 107 ANDA approvals (95 final approvals and 12 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 ~ACU;i: manufacturing facilities are approved by regulatory authorities of many developed countri !t-~ 101- ::; VADODARA <f> ALEMBIC PHARMACEUTICALS LIMITED \ 390 003 f REGO. OFFICE : ALEMBIC ROAD, VADODARA - 390 003. • TEL : (0265) 2280550, 2280880 • FAX : (0265) 2281229 ~}t,, C>~'y website : www.alembicpharmaceuticals.com • E-mail : [email protected] • CIN : L24230GJ2010PLC061123 A!!.T.!?ftJi) 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). For more information contact: Ajay Kumar Desai Phone: +91 22 - 306 11681 Mitanshu Shah Phone: +91 265 - 3007630 Email: mitanshu.shah alembic.co.in .) ALEMBIC PHARMACEUTICALS LIMITED REGO. OFFICE : ALEMBIC ROAD, VADODARA - 390 003. • TEL : (0265) 2280550, 2280880 • FAX : (0265) 2281229 website : www.alembicpharmaceuticals.com • E-mail : [email protected] • CIN : L24230GJ2010PLC061123
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