Corporate Profile: Alembic Pharmaceuticals, Inc

Generic SupplementsAugust 2021 Generic Supplement
Pages: 42

Alembic Pharmaceuticals, Inc in Bridgewater, NJ is a subsidiary of Alembic Pharmaceuticals Ltd., the oldest pharmaceutical company in India, employing more than 12,000 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 across the globe. Alembic Pharmaceuticals Ltd. is listed on the Bombay Stock Exchange under the stock symbol (APLLTD). Alembic is a vertically integrated organization with expertise spanning across the entire pharmaceuticals value chain: Research & Development, Manufacturing and Marketing of finished dosage formulations, as well as 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 FY 2021, Alembic invested 12.4% of sales into R&D with over 90% focused on ANDAs for 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 1,200 scientists, Alembic has been a leader in development of active pharmaceutical ingredients, generic drug formulations (ANDAs), and new chemical entities. Alembic currently boasts 117 Drug Master Files (DMFs), 128 approved ANDAs, 16 Tentative Approvals and 1 NDA – 505(b) (2) as well as 212 ANDAs filed in total. In addition, Alembic has a 150-patient bed FDA approved bio-equivalence center to support ANDA filings.

State of the Art Facilities

Alembic supplies products from 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, Pregabalin, and Valsartan. These facilities are in compliance with standards of the US FDA, UK MHRA and TGA Australia amongst others and all have been recently 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 at print sells 89 products in the U.S. representing more than 330 SKUs under its own label. Alembic has continued to expand its product offering and now offers solid oral, dermatology, ophthalmic products covering a broad range of indications. For 2021 Alembic plans to launch 15+ generic products in the US market. In total, Alembic has 250+ ongoing product projects for the US market. Alembic has also completed construction of an Oncology injectables and has submitted products from approval for this facility. A second solid oral dose facility has also been completed and awaiting final FDA approval which will provide new products and redundancy for existing products.

“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 Eric Purcell, Vice President of Sales and Marketing at Alembic Pharmaceuticals, Inc.

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