Execs at India's Dr. Reddy's Laboratories recently highlighted how investments in plant upgrades had taken much of the human involvement out of drug production, allowing it to sidestep the kinds of FDA problems that have brought down manufacturing plants for compatriots Ranbaxy Laboratories and Wockhardt. But the improvements don't make production fool-proof, and the drugmaker is voluntarily recalling a lot of generic Toprol XL as well as an unknown amount of an acid reflux drug it manufactured for someone else.
The two recalls were outlined in the FDA's most recent Enforcement Report, which said Dr. Reddy's was voluntarily recalling 13,560 bottles of metoprolol succinate extended-release tablets, a generic of AstraZeneca's ($AZN) blood pressure med Toprol XL, because it had failed dissolution testing in an 18-month check.
It is also recalling delayed-release tablets of pantoprazole sodium, a generic of Pfizer's ($PFE) Protonix, that it was making for Livonia, MI-based Major Pharmaceuticals. That recall was issued because some cartons that were labeled as as the stomach upset drug may contain blister cards of lorazepam tablets, a generic antianxiety drug.
V. Venkatanaryan, the head of Dr. Reddy's Bachupally plant, recently told The Wall Street Journal that the company had turned to using more automated equipment to get workers uninvolved in the production process because it lessened the chances of human error. The company invested about $150 million in plants and equipment in an effort to make its processes "mistake proof."
Dr. Reddy's has had other recalls as well. In August 2013 it recalled a lot of the gastroesophageal reflux drug ranitidine hydrochloride sold under private label brands by Walmart, Walgreens and others because the API used to make it had bacterial contamination. But it hasn't faced the import alerts that many of its Indian competitors are now dealing with.
In the last year, the FDA has banned two Wockhardt plants, two more of Ranbaxy Laboratories' plants, and one operated by Sun Pharmaceutical. Sun recently struck a deal with Daiichi Sankyo, which has majority control of Ranbaxy, to buy the Indian drugmaker for $3.2 billion, a deal that was prompted by Ranbaxy's ongoing regulatory issues. Among other problems, all three drugmakers were accused of manipulating testing data to get passing results for some of their products that initially failed testing.
- here's one recall notice
- and another