Cadila Healthcare secured the highest number of ANDA (abbreviated new drug application) approvals among Indian pharmaceutical companies during the past nine month period.
The country’s fourth-largest drugmaker by market cap has received 70 ANDA approvals in the current financial year (Image 1). Out the total, 21 ANDA approvals were received by the company during the previous quarter.
The drug makers are required to obtain ANDA approval from the FDA to manufacture and market the low-cost generic alternative to the brand-name drug in the US market.
Cadila witnessed a remarkable growth in the number of ANDA approvals in the current financial year 2018 (Image 2). The company’s ANDA approvals moved up significantly from 14 in FY17 to 70 in 9MFY18.
With these approvals, the company has now over 180 approvals out of its cumulative filing of over 310 ANDAs since the commencement of the filing process in FY 2003-04.
In our view, the surge in ANDA approvals in FY18 augurs well for Cadila Healthcare as it opens up new opportunities for the company to generate higher sales from the US drug market.
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