Profile: Alembic Pharmaceuticals, Inc

Alembic Pharmaceuticals, Inc is a subsidiary of Alembic Pharmaceuticals Ltd., the oldest pharmaceutical company in India, employing more than 13,000 people globally. Alembic Pharmaceuticals Ltd is one of the most well-respected, established, and integrated pharmaceutical companies in Asia and supplies products to over 90 countries. Alembic Pharmaceuticals Ltd is listed on the Bombay Stock Exchange and National Stock Exchange under the stock symbol APLLTD. Alembic is a vertically integrated organization with expertise spanning the entire pharmaceuticals value chain: research and development (R&D), manufacturing and marketing of finished dosage formulations, active pharmaceutical ingredients, and intermediates.

RESEARCH AND DEVELOPMENT A KEY STRENGTH

Alembic’s strong growth and success are built on a foundation of strong and innovative R&D. In 2019, Alembic invested approximately 14% of sales into R&D with

over 90% focused on abbreviated new drug applications (ANDAs) for the US market. With 2 research facilities in India (Vadodara and Hyderabad) and 1 in the US (West Caldwell, New Jersey) and a team of over 500 scientists, Alembic has been a leader in development of active pharmaceutical ingredients, generic drug formulations (ANDAs), and novel drug delivery systems. Alembic currently boasts 109 drug master files, 110 approved ANDAs, 12 tentative approvals, and 1 NDA/505(b)(2), as well as 189 ANDAs filed in total. Alembic announced plans to file an additional 100 ANDAs over the next 3 years. In addition, Alembic has an FDA-approved bio-equivalence center to support ANDA filings.

FACILITIES

Alembic supplies products for 5 FDA approved facilities in India. These facilities have supplied product to the US market for over 10 years. These facilities are in compliance with standards of the US FDA, UK, and others, and all have recently been inspected by the US FDA.

US FOCUS AND GROWTH

Alembic Pharmaceuticals Ltd, via its subsidiary Alembic Pharmaceuticals, Inc, has identified the US as its key focus market. Alembic has experienced tremendous growth in the US since its first launch in October 2015 and now sells over 72 products in the U.S. representing more than 250 stock-keeping unit (SKUs) under its own label. 2019 marked the launch of key dermatology and ophthalmic products for Alembic in the US. Alembic intends to launch another 10-plus products before year end 2020

and will launch 8 to 10 products each year over the next 3 years. In addition, Alembic has finished completion of an oncology injectables facility and has begun filing for product approvals. In total, Alembic has 250 ongoing projects, which include targets in dermatology, injectables, and ophthalmics. “Alembic has experienced tremendous growth in the US market over the past several years and is poised for continued success as new projects come to market. It’s exciting to be part of a dynamic organization focused on growth and servicing our customers,” said Eric Purcell, vice president of sales and marketing at Alembic Pharmaceuticals, Inc.

For more information, contact:

Eric Purell, Vice President, Sales and Marketing

(908)-393-9604 x108

Eric.Purell@alembicusa.com

For more information, visit:

alembicusa.com