Emcure India plant banned by the FDA

Courtesy of Emcure

Add Emcure to the significant list of Indian drugmakers with plants banned by the FDA. An import alert for all human and animal drugs from an Emcure Pharmaceuticals plant in Hinjawadi, with a few exceptions, was issued Monday, according to the FDA.

Nine drugs were excluded from the detention without physical examination, or DWPE. Among those 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. A spokesperson for the company was unavailable, according to Reuters.

No specifics are given on the alerts, which simply say the bans are for violations of cGMP standards. Emcure has received no FDA warning letters, although those are often posted after an import alert has been issued. But problems that the FDA may have uncovered at the plant were alluded to when Teva ($TEVA) had to recall nearly 40,000 drugs in May 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.

Such deviations, in which companies manipulate drug testing analysis to get the results needed to approve batches, has been found over and over again by the agency. It was among the problems that led the FDA to ban four plants owned by Ranbaxy Laboratories, which was bought out by Sun Pharmaceutical for $4 billion this year. Those plants now operate under a consent decree from the FDA, and the company paid $500 million to resolve civil litigation that sprang from the problems.

Sun Pharmaceutical has had a plant banned in part for the same reason, as has Wockhardt, which has had two of its plants in India prevented from selling into the U.S. market. In a warning letter for the Wockhardt plant in Chikalthana, the FDA noted that employees were testing "trial samples" of some drugs, then linking results from those to official samples that had not met test requirements.

- access the import alert here
- here's the Reuters story

Suggested Articles

McCallum was hit with a warning letter from the FDA for testing issues with its products and failing to keep appropriate records.

The FDA made public a voluntary recall of sterile injectables made by Coastal Meds of Mississippi, after visible particles were found in some vials.

It’s been a strange road for BMS' Opdivo-Yervoy combo in first-line kidney cancer, but the New Jersey drugmaker finally has a go-ahead.