Alembic Pharmaceuticals

Generic SupplementsGeneric Supplement 2016

Alembic Pharmaceuticals, Inc., is a subsidiary of Alembic Pharmaceuticals, Ltd., the oldest pharmaceutical company in India.

Alembic Pharmaceuticals, Inc., is a subsidiary of Alembic Pharmaceuticals, Ltd., the oldest pharmaceutical company in India. Alembic Pharmaceuticals, Limited., employs more than 8000 people and is one of the most respected, established, and integrated pharmaceutical companies in Asia, supplying products to more than 90 countries around the world. 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 (R&D), Manufacturing and Marketing of finished dosage formulations, as well as active pharmaceutical ingredients and intermediates.


Alembic’s strong growth and success are built on a foundation of strong and innovative R&D. In 2015, Alembic invested over 7% of sales into R&D. With research facilities in Vadodara and Hyderabad, India, and a team of more than 400 scientists, Alembic has been a leader in development of active pharmaceutical ingredients, generic drug formulations (abbreviated new drug applications (ANDAs), and novel drug delivery systems. Alembic currently boasts 79 Drug Master Files (DMFs), 42 approved ANDAs, 5 tentative approvals, and 1 NDA—505(b)(2), as well as 76 ANDAs filed, in total. Additionally, Alembic has a 90 patientbed FDA-approved bioequivalence center for ANDA filings.


Alembic supplies products from 4 FDA-approved facilities in India (1 finished-dose and 3 API facilities). These facilities have supplied product to the US market for more than 10 years and include products such as Aripiprazole ODT, Celecoxib Capsules, Modafinil Tablets, and Theophylline ER. Please visit the Alembic website for a full list of products available through Alembic Pharmaceuticals US and full prescribing information at These facilities are in compliance with standards of the FDA, UK MHRA, and TGA Australia, among others, and have recently been inspected by the FDA.


Alembic has identified the United States as the key market for expansion and development. Alembic has experienced tremendous growth since its first launch in October 2015. The company now sells more than 23 products in the United States, representing more than 100 SKUs under its own label. Alembic intends to launch another 10 products before yearend 2016, and will launch 8 to 10 products each year over the next 3 years. In addition, Alembic is finishing completion of an oncology injectables facility that will be operational in 1Q 2017. In total, Alembic has 225 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 serving our customers and, ultimately, patients,” said Armando Kellum, Vice President of Sales and Marketing at Alembic Pharmaceuticals, Inc.

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