Sun Pharmaceutical, which has touted itself as having the skills to fix quality problems at Ranbaxy Laboratories, is recalling two more lots of an antidepressant. The recall is its third since its April announcement that it would buy its troubled competitor in a $3.2 billion deal.
An FDA Enforcement Report says that 26,530 bottles of venlafaxine hydrochloride extended-release tablets, a generic of Pfizer's ($PFE) Effexor XR, are being pulled because the tablets do not dissolve properly. Like the previous recall, the drugs were distributed by its U.S. subsidiary Caraco Pharmaceutical Laboratories but manufactured at a plant in India. The recall in May of nearly 252,000 bottles of venlafaxine as well as 128,363 bottles of the decongestant cetirizine was also over the concern that the drugs might not release into the body as they are supposed to.
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| Sun Pharma Managing Director Dilip Shanghvi |
When Sun announced its plan to buy Ranbaxy, Sun's managing director, Dilip Shanghvi, proclaimed that the first order of business when the deal closed was to resolve the manufacturing issues that have plagued Ranbaxy. Those problems have resulted in the FDA banning imports of products from four of Ranbaxy's 5 FDA-approved plants, two in the past year, moves that have severely crimped Ranbaxy's revenues.
It is not as though Sun has not had issues of its own. The FDA issued an import alert in March against one of Sun's Indian plants for some of the same analytic and testing failures for which the FDA nailed Ranbaxy. It has been since then that Sun has had to recall products for failed stability tests.
In one bit of good news for the soon-to-be-married companies, the FDA ago approved Ranbaxy two weeks to make its exclusive generic of the Novartis ($NVS) heart drug Diovan at its Ohm plant in New Jersey. The launch has been delayed by Ranbaxy's regulatory entanglements since the drug went off patent in September 2012, a delay that has provided a windfall for Novartis while keeping consumers, and federal health programs, from enjoying the price cut that will result from a generic of the blockbuster drug. The deal to buy Ranbaxy is expected to close by the end of the year.
- here's the FDA recall notice