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.
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.