Emcure, which has issues with FDA, buys Canadian firms

Health Canada asked Indian drugmaker Emcure Pharmaceuticals to voluntarily quarantine products last year after hearing that the FDA had banned most products coming out one of its Indian plants. The company has found another way to expand in that market, however, buying two related Ottawa-based drug operations.

Sources told the Economic Times that Emcure had acquired International Pharmaceutical Generics and its marketing operation Marcan Pharmaceuticals to broaden its generics business. The company did not respond to the publication's request for a comment.

Health Canada took its action after the FDA put Emcure's plant in Hinjawadi on the import alert list in July, banning all but 9 of the products produced there. Among those that were excluded was cidofovir, a generic of Gilead Sciences' ($GILD) Vistide, which is used to treat eye infections in people with AIDS, as well as the antipsychotic haloperidol and cancer drug carmustine. The agency said it is continuing to review evidence submitted from its regulatory partner.

The FDA gave no specifics on the reason for the import alert, which simply says the bans are for violations of cGMP standards. But Emcure, which operates its U.S. business through Heritage Pharmaceuticals, last year recalled 10 lots of injected Colistimethate and three lots of injected Rifampin, saying it was because of "FDA observations pertaining to aseptic and GMP practices at the manufacturer's site potentially impacting product sterility."

Teva ($TEVA) had to recall nearly 40,000 drugs in 2014 that had been manufactured for it by Emcure at the plant in Hinjawadi. The products were recalled for deviations in lab testing, an issue the FDA has frequently uncovered at Indian plants. Also, last November Heritage received a warning letter for not properly reporting adverse reactions.

- read the Economic Times story