Roussel Uclaf Stops Bulk Generics To USA

Hoechst affiliate Roussel Uclaf has halted shipments of three active ingredients for generics (namely cefaclor, minocycline and clindamicin) to the USA from its Italian subsidiary, Biochimica OPOS, because the plant's production methods no longer complied with US Food and Drug Administration requirements. The news saw RU's share price fall 2.2% on November 8. The difficulties are said to be linked with administration rather than actual production.

The three active ingredients, says the Financial Times, have US sales of around $60 million; RU will withdraw its current abbreviated New Drug Applications and will submit revised ANDAs. The Hoechst group has two major generics subsidiaries in the USA, Copley and Rugby.