Drug firm Alembic Pharmaceuticals is looking at filing 100 abbreviated new drug applications with the US health regulator over the next three years starting this fiscal as part of its expansion plans.
An ANDA contains data that provides for the review and ultimate approval of a generic drug product by the United States Food and Drug Administration (USFDA).
“…We hope to file 100 ANDAs in the next three years (starting 2017-18) – a sizable proportion of which would comprise challenging products (Para IV/First To File (FTF) opportunities),” Alembic Pharmaceuticals MD Pranav Amin said.
The company is also aiming to launch up to 12 products per year in America during this time.
“We target to launch 10-12 products each year in the US market during the same timeframe,” Amin said in his statement in the Annual Report of the company for the fiscal year ended March 31, 2017.
Stronger regulatory filing pace is a immediate fallout of the company’s R&D efforts.
Highlighting the efforts the company is undertaking to make the US business stronger, Amin said: “We invested more than Rs 900 crore towards this goal in 2016-17, of which about Rs 450 crore has been deployed in R&D initiatives and about Rs 475 crore has been invested in capacity creation.”
Aligned with the R&D efforts, the company is creating the requisite manufacturing infrastructure for ensuring timely supplies upon receiving regulatory approvals, he added.
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 said.