The US regulator visited Neuland’s active pharmaceutical ingredient (API) production facility outside Hyderabad and deemed that the site complied with good manufacturing practices (GMP) requirements.
CEO Sucheth Davuluri said: “In our 30 years of operations, achieving the highest standards of quality and regulatory excellence have been core values for Neuland. We were proud to have been one of the first contract manufacturing companies in India to be inspected by the FDA in 1997.”
According to Davuluri, 90% of the Bombay Stock Exchange (BSE) listed firm’s customers are in Europe, the US and Japan.
Neuland’s business in Japan includes the 2013 agreement it signed with API Corporation (APIC), a unit of Mitsubishi Holdings Group, that prompted the CMO to open the facility that passed the FDA audit.