The Hikma Farmacêutica S.a facility in Terrugem, Portugal, is the manufacturing heart of Hikma Group’s generic injectables business. It produces powder, liquid and lyophilised parenterals for the US and EMEA markets.
The FDA sent a letter to Hikma last week, following an inspection in March.
Hikma spokesman Matthew Cole told in-Pharmatechnologist.com the FDA had found issue with “investigations and environmental monitoring procedures” at the plant. Environmental monitoring measures levels of contaminants at plants, such as air or water quality.
The 9.5km2 (6 miles sq) site includes production, packaging, warehouse and lab facilities.
Hikma said it did not expect the letter to affect manufacturing or distribution at the plant.
In 2012, a Warning Letter for Hikma’s oral manufacturing plant in Eatentown, New Jersey caused a one-year shutdown over equipment and control procedure problems.
But Cole said the Portgual site was “a different situation, and a different letter.”
On the other hand, Citi Research analysts said approval of new products from Hikma’s R&D line in Portugal would be affected by the letter, reported Reuters:
"We estimate Portugal remediation will likely be less disruptive and expensive vs Eatontown, but acknowledge that resolving warning letters typically tends to be a long drawn out process."
In May this year, Hikma acquired Boehringer Ingelheim’s generic injectables business for $300m (€236m), as well as acquiring from Boehringer its Ben Venue manufacturing facility in Ohio.
Altogether, injectibles accounted for $536m – 39% - of Hikma’s 2013 revenue. The Portugal plant is estimated to account for about a quarter of these sales.