Alembic to step up product filings for US

The Vadodara-based Alembic Pharmaceuticals is planning to raise its annual product filings for regulated markets from seven or eight now to 30 within two years.

Alembic has increased the number of its projects for product development from 40 in 2013-14 to 200 now. The projects are largely to develop products in injectables and dermatology. These include its own, partnered, and in-licensed products.

"This R&D effort is expected to increase filings from 76 in 2015-16 to around 176 in the next 2-3 years," said an analyst.

A senior executive said Alembic was in the process of setting up  front end operations in the US. "With this, we expect more profitability from our products in the US market," he added.

Alembic has outlined an expenditure of around Rs 700-800 crore for capacity expansion of injectables and dermatology products. It aims to complete the expansion on injectables by the end of 2016 while  oral solids for the oncology segment will be completed by the end of 2016-17. This will be followed by completion of the dermatology products expansion, which is expected around 2017-18.

Earlier this week, the company’s formulations facility  at Panelav received an Establishment Inspection Report from the US Food & Drug Administration (FDA) for inspection carried out in March 2016.

The US accounts for nearly 80-85 per cent of Alembic's international formulations business. The company's Panelav unit had received minor observations (as a Form 483) from the FDA in March this year. A Form 483 is issued to a company after an inspection is completed and investigators have observed any condition that may constitute violations of the US Food, Drug and Cosmetics Act and related laws.

Panelav makes formulations for regulated markets and has the capacity to manufacture 7 billion tablets and capsules per year. The formulations business accounts for nearly 86 per cent of Alembic’s revenues. The share of international business is around 50 per cent of its turnover.  

The company has manufacturing facilities at Vadodara and Panelav in Gujarat and in Baddi in Himachal Pradesh.

On the domestic front, Alembic’s domestic formulations revenue registered 13.8 per cent annual growth over 2013-16.