ALEMBIC PHARMACEUTICALS LIMITED PRESS RELEASE
18thJuly, 2017, Vadodara ,India
Alembic Pharmaceuticals receives USFDA Approvalfor Olmesartan Medoxomiland Amlodi pineTablets
Alembic Pharmaceuticals Limited todayannounced that thecompany has received approvalfromthe USFood & Drug Administration (USFDA) for its Abbreviated NewDrug Application(ANDA)for Olmesartan Medoxomil andAmlodipine Tablets,20 mg/5 mg,40 mg/5mg, 20 mg/10 mg, and40 mg/10mg. The approved ANDA is therapeutically equivalentto the referencelisted drug product (RLD) Azor® Tablets,20 mg/5mg, 40mg/5 mg, 20 mg/10mg, and 40 mg/10 mg, of DaiichiSankyo Inc.Olmesartan Medoxomiland Amlodipine Tabletsare indicatedfor the treatmentof hypertension,alone orwith otherantihypertensive agents to lowerblood pressure.
Olmesartan Medoxomiland Amlodipine Tablets have an estimated market size ofUS$ 312 millionfor twelve months ending December 20 16 according to IMS.
Alembic now has a total of 61ANDA approvals(53 finalapprovals and 8tentative approvals) from USFDA.
About Alemb ic Pharmaceuti cals Limited
Alembic Pharmaceutica ls Limited, a vertically integrated research and development pharmaceutical company, has been at theforefront of healthcare since 1907. Headquarteredin India, Alembic isa publiclylisted company that manufacturesand markets generic pharmaceutical products all over theworld.Alembic's state of the art research and manufacturing facilitiesare approved by regulatory authorities of manydeveioped countries including the USFDA.Alembic is one of the leaders in branded generics in India.Alembic's brands, marketed througha marketing team of over 5000 are well recognized by doctorsand patients.
Information about the company can be found at http://www.al embicpharmaceuti cals.com/; (Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLLTD) (BSE: 533573)
For moreinformation contact:
AjayKumarDesai MitanshuShah
Phone: +9122 - 306 11681Phone: +91 265 -3007630
Email:ajay.desai @alemb ic .co.in Email:mitanshu.shah@al embic.co.in
ALEMBIC PHARMACEUTICALS LIMITEDREG.OFFICE :ALE BIC ROAD,ADODARA •390 003.•TEL :(0265) 2280550,2280880 •FAX:{0265)2281229
website :www.alemb1cpharmaceut1ca s.com • E-mail:alembic@alembic.co.in • CIN:L24230GJ2010PLC061123
Alembic Pharmaceuticals Limited published this content on 18 July 2017 and is solely responsible for the information contained herein.
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