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Alembic Pharmaceuticals plans to file 100 ANDAs with US health regulator

07 Jun 2017 Evaluate

Drug firm Alembic Pharmaceuticals is looking at filing 100 abbreviated new drug applications (ANDAs) with the US health regulator United States Food and Drug Administration (USFDA) over the next three years starting this fiscal as part of its expansion plans. The company is also aiming to launch up to 12 products per year in America during this time.

Aligned with the R&D efforts, the company is creating the requisite manufacturing infrastructure for ensuring timely supplies upon receiving regulatory approvals. Around 90 per cent of the company's R&D resources are allocated towards developing products for the US markets which, in turn, can be leveraged for strengthening presence in other regulated markets.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907. The company manufactures and markets generic pharmaceuticals products all over the world.

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