Sun Pharmaceutical's U.S. subsidiary Caraco Pharmaceutical Laboratories has had a series of recalls this year of products that came out of a plant in Gujarat in India. Now the plant is being visited by FDA inspectors.
Officials with the company declined to confirm the inspection, but sources tell the Business Standard that inspectors were in the facility and that the recalls may have triggered the visit.
In July, the company recalled 26,530 bottles of venlafaxine hydrochloride extended-release tablets, a generic of Pfizer's ($PFE) Effexor XR, because the tablets do not dissolve properly. A recall in May of nearly 252,000 bottles of venlafaxine as well as 128,363 bottles of the decongestant cetirizine were also over the concern that the drugs might not release into the body as they are supposed to. Another Sun plant in Mumbai in August recalled 500,000 bottles of antibiotics.
The plant currently being inspected is not the same facility in Gujarat that the FDA in March put on its import alert list. A warning letter for that plant issued in May slammed it for suspect drug testing, among other issues.
The regulatory actions come at a sensitive time for the Indian drugmaker. In April it made a $4 billion, all-stock offer for Ranbaxy Laboratories, India's largest domestic drugmaker, and one that has had years of serious regulatory problems with the FDA. That deal is slated to close by the end of the year.
- here's the Business Standard story
- here's a Reuters report