Sun's Taro recalls 62,800 tubes of Topicort

Sun Pharma Managing Director Dilip Shanghvi

Sun Pharmaceutical’s U.S.-based Taro Pharmaceutical Industries helped the Indian drugmaker boost its U.S. sales in its last fiscal year, but the skin care specialist has hit a small manufacturing glitch and is recalling a product that failed to hit some specifications.

According to the most recent FDA Enforcement Report, Taro is voluntarily recalling 62,800 tubes of Topicort Cream (desoximetasone) manufactured in Canada because the product may be subpotent. The steroid cream is used to treat skin irritations.

The recall comes as the Indian drugmaker has its hands full with manufacturing problems in India where it is working to get some of the Ranbaxy plants it acquired last year ready for reinspections; it's also doing remediation at a legacy plant that is key to U.S. sales. The Ranbaxy plants had been banned by the FDA for a number of manufacturing problems ahead of Sun’s $4 billion buyout of Ranbaxy.

In an analyst call this week for its fiscal year ended March 31, Sun Managing Director Dilip Shanghvi said the company hopes that one of the Ranbaxy plants will be reinspected by the FDA by the middle of FY17.

But Sun is also having to do remediation at its plant in Halol. That interruption has dampened its U.S. sales over the last year. Citing an analyst report from Jefferies, NDTV reports upgrades at Halol are expected to be completed by the end of June, which will mean Sun will have several more quarters of dampened sales before it can get back on track.  

As for Taro, it posted Q4 sales of $265 million, up 9%, and full-year sales of $951 million, up 10%. That helped the Indian drugmaker grow Q4 U.S. sales to $580 million, up 19%, and accounting for 52% of the company’s total sales there. But for the full year, Sun's U.S. sales of $2 billion were off 8%.

- find the recall here 
- get Sun’s financial release 
- read the LiveMint story

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