New Delhi: Drug major Cipla has said it is looking to file more than 20 applications seeking approval for its generic medicines from the US health regulator this fiscal.
In the last financial year, the company had filed 32 abbreviated new drug applications (ANDAs) in the US.
An ANDA contains data that provides for review and ultimate approval of a generic drug product by the US Food and Drug Administration (USFDA).
“In the US, we are eyeing over 20 ANDA filings, strengthening the execution of key launches, and building our speciality focus in respiratory and CNS,” Cipla MD and CEO Umang Vohra said in a message to the shareholders in the Annual Report 2016-17.
According to the report, Cipla has identified Respiratory and Central Nervous System (CNS) in speciality segment as its core focus therapy areas with an aim to further accelerate growth in the US market.
The company said it will continue to focus on investing towards building its speciality franchise through a combination of development within the company and inorganic opportunities.
Besides, Cipla will also work towards bolstering leadership position in India, South Africa, and key Emerging Markets, Vohra said.
“Our biggest imperative in FY18 will be to generate sustainable and profitable top-line growth, and to build a strong organisation,” he added.
Given the challenges related to GST and certain key product launches in the US market, the company expects higher growth in the second half of the next fiscal, the report said.