Sun Pharmaceutical Industries on Wednesday announced that it received the first product approval from the US drug regulator filed from the Halol facility (Gujarat), after the facility was cleared last month.
Halol’s non-compliance has held up fresh product approvals from the site for nearly four years, and is partly responsible for the muted growth in the US for Sun.
It received the nod for an oncology injectable Infugem to be manufactured at the Gujarat facility.
The chemotherapy drug has an addressable market size of approximately $35 million for the 12 months ending March 2018, as per IQVIA.
The Halol unit received Establishment Inspection Report (EIR) last month, that brought to closure the three-year long regulatory hurdle the plant was facing with the US Food and Drug Administration (USFDA).
The regulator had inspected the plant in 2014 and issued a warning letter in December 2015, following which Sun Pharma could not file for fresh approvals from the site.
In June, the USFDA closed the inspection, paving way for fresh approvals. India Infoline said, “The approval means the plant is fully functional and we can see many such approvals from this plant. Due to compliance issues and warning letter on this facility, several product approvals were blocked by the USFDA."
Analysts feel Halol’s resolution could add as much as $100 million in revenues annually.
Abhay Gandhi, chief executive officer (North America region), said: “We’re pleased to add this novel product to our expanding oncology portfolio as gemcitabine is one of the most commonly used cytotoxics in oncology practice.”