PRESS RELEASE

4thJuly, 2017,Vadodara, India

Alembic Pharmaceuti cals receives USFDA TentativeApproval for Vardenafil Hydrochloride OrallyDisintegrating Tablets

Alembic Pharmaceuticals Limited today announced that thecompany has received tentative approval from the US Food &Drug Administration (USFDA) forits Abbreviated New Drug Application (ANDA) for Vardenafil Hydrochloride OrallyDisintegrating Tablets,10mg. The tentatively approved ANDA is therapeuticallyequivalent to the reference listed drug product (RLD) STAXYN® OrallyDisintegrating Tablets,10mg,ofBayer Healthcare and is used under license by GlaxoSmithKline. VardenafilHydrochloride OrallyDisintegrating Tablets, areindicated for the treatment of erectile dysfunction.

Vardenafil Hydrochloride Orally Disintegrating Tabletshave an estimated market sizeof US$ 9.5 million for twelve months ending December 2016 according to IMS.Alembic is currentlyin litigation with Bayer in District Courtof Delaware and the launch of this product will depend on theoutcome of litigation.

Alembic now has a total of 59 ANDA approvals (52 final approvals and 7 tentative approvals) fromUSFDA.

About Alembic PharmaceuticalsLimited

Alembic Pharmaceuticals Limited,a vertically integratedresearch and development pharmaceutical company,has been atthe forefront of healthcare since 1907.Headquartered inIndia, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical productsall over the world. Alembic's stateof the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leadersin branded generics inIndia.Alembic's brands, marketed through a marketing team ofover 5000 are well recognizedby doctors and patients.

Information about the company can be found at http:f/www.alembicpharmaceuticals.com/; (Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLLTD) (BSE:533573)

For more information contact:

Ajay Kumar Desai

Phone: +91 22 -306 11681

Email: ajay.desai@alembic.co.in

Mitanshu Shah

Phone: +91 265- 3007630

Email:mitanshu.shah@alembic.co.in

ALEMBIC PHARMACEUTICALS LIMITED

REG.OFFICE :ALEMBIC ROAD,VADODARA - 390 003. •TEL :(0265) 2280550, 2280880 •FAX :(0265)2281229

website :www.alembicpharmaceuticals.com• E-mail:alembic@alembic.co.in •CIN :L24230GJ2010PLC061123

Alembic Pharmaceuticals Limited published this content on 04 July 2017 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 05 July 2017 07:05:12 UTC.

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