Lupin leader crosses fingers for fast resolution of Form 483

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Lupin has big plans to build market share in the U.S., but those plans were stymied when the FDA cited a facility in Goa from which it expects to ship new products. The head of the Indian drugmaker is now saying that he thinks the facility is in good shape and that it will get an FDA signoff in the next couple of months.

Managing Director Nilesh Gupta told Bloomberg last week that he expects the FDA to approve its action plan and begin approving new products for production from the facility. 

"I’m hoping that in the next one or two months we’ll have clarity as far as the site is concerned,” Gupta told the news service. “Clarity to me is product approvals."

He said the company will send the FDA its final response in December, which he hopes will mean that the Form 483 the facility received will be cleared shortly thereafter. 

Lupin, India’s second largest drugmaker behind Sun Pharmaceutical, has about a dozen products it believes are ready for the U.S. market, says Gupta who believes each would generate between $20 million and $30 million in annual revenue. Lupin gets more than 40% of its revenues from the U.S. market and Gupta said the Goa plant was expected to be the source of most of its new product approvals in the near term. 

"It’s already affecting our existing business," Gupta told Bloomberg about the FDA citation.  

Lupin is among many Indian drugmakers, including many of the largest, that have had plants cited in recent years by the FDA. Some Indian drugmakers are trying to counter issues at their Indian facilities by acquiring U.S. facilities that they believe are more attuned to FDA standards. 

Lupin did that earlier this year with the $880 million acquisition of Gavis Pharmaceutical. The New Jersey company, founded by Veerappan Subramanian, specializes in niche products including dermatology and controlled substances. 

With Gavis, Lupin got a 45,000-square-foot manufacturing and R&D operation in Somerset, NJ, and 124,000 square feet of packaging and distribution operations. 

- read the Bloomberg story

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