Bridgewater, N.J.—Alembic Pharmaceuticals, Inc. is a subsidiary of Alembic Pharmaceuticals Ltd. the oldest pharmaceutical company in India, employing more than 13,000 people. 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 under the stock symbol APLLTD. Alembic is a vertically integrated organization with expertise spanning the entire pharmaceuticals value chain: research & development, manufacturing and marketing of finished dosage formulations, active pharmaceutical ingredients, and intermediates.

RESEARCH AND DEVELOPMENT A KEY STRENGTH
Alembic’s strong growth and success is built on a foundation of strong and innovative R&D. In 2019, Alembic invested approximately 13% of sales into R&D with over 90% focused on the U.S. market. With two research facilities in India (Vadodara and Hyderabad) and one in the U.S.(West Caldwell, NJ) and a team of over 1,100 scientists, Alembic has been a leader in development of active pharmaceutical ingredients, generic drug formulations (ANDAs), and novel drug delivery systems. Alembic currently boasts 100 drug master files, 86 approved ANDAs, 12 tentative approvals and 1 NDA/505(b) (2), as well as 165 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 (1 solid oral finished dose, 1 dermatology facility and 3 API facilities). These facilities have supplied product to the US market for over 10 years and include products such as aripiprazole, febuxostat, leflunomide, olmesartan, pregablin, valsartan, and theophylline extended release. These facilities are in compliance with standards of the US FDA, UK, and others and all have recently been inspected by US FDA.

US FOCUS AND GROWTH
Alembic Pharmaceuticals Ltd., via its subsidiary Alembic Pharmaceuticals, Inc., has identified the U.S. as its key focus market. Alembic has experienced tremendous growth in the U.S. since its first launch in October 2015 and now sells over 57 products in the U.S. representing more than 250 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+ products before year end 2019 and will launch 8-10 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 240 ongoing projects which include targets in dermatology, injectables, and ophthalmics. “It’s very exciting to be part of such a dynamic organization that is focused on growth and servicing our customers and ultimately patients” said Armando Kellum, vice president of sales and marketing at Alembic Pharmaceuticals, Inc.

For more information contact:
Armando Kellum
Vice President, Sales and Marketing
(908) 393-9604
Armando.kellum@alembicusa.com 

For more information, visit alembicusa.com.