The company has at least ten para IV filings for the US.
Ahmedabad-based Cadila Healthcare is planning to launch 50 products in the US during the current fiscal year. The company has at least ten para IV filings for the US.
If a company files an abbreviated new drug application (ANDA) containing a paragraph IV certification with the US Food and Drug Administration (USFDA), then its product (when it gets the final approval from the FDA) can be eligible for 180 days of marketing exclusivity.
A senior executive of the company said, "We plan to launch at least 50 products in the US market during FY19. There are over 140 ANDAs pending approval and of this, many are para-IV filings. We already received around 77 approvals last fiscal. Our future launches would be in transdermal, injectables, oral solids etc."
The revenue of Cadila Healthcare has grown 27% in FY18 led by a 64% surge in the US business. While the domestic business grew around 3% year on year impacted by goods and service tax-related disruptions.