Sun to ask for FDA reinspection of troubled Halol plant

India's Sun Pharmaceutical continues to see sales in the U.S., its largest market, dogged by FDA concerns at a key plant in India but is expecting that to change this year.

India's largest drugmaker reported last week that its U.S. sales were off 11% to $486 million in the quarter ended Dec. 31, 2015. They are down 15% to $1.48 billion for the 9 months in the U.S., a market that accounted for about 45% of its revenues.

The Mumbai-based company said the source of those issues was "primarily due to competitive pressure on some products and temporary supply constraints arising from remediation efforts at the Halol facility." Sun has been seeing sales slip in the U.S. since 2014 when the FDA cited its Halol plant with a Form 483. The agency issued a warning letter to the plant last December for a host of quality and data integrity issues.

Sun Pharmaceutical Managing Director Dilip Shanghvi

But Sun founder and Managing Director Dilip Shanghvi said in a call with analysts that Sun hopes in the Q1 2017 to request an FDA reinspection of the facility, the Economic Times reports. He also said that the company is not considering moving production of any products from Halol to other facilities.

When Sun Pharma last year closed on its $4 billion deal to buy long-troubled competitor Ranbaxy Laboratories, Sun appeared to be on the cusp of realizing Shanghvi's long-held goal of becoming a major player in the U.S. and on the world stage. He pledged at the time to bring Ranbaxy's plants, four of which are been banned by the FDA from shipping to the U.S., back into the good graces of the FDA. But instead it has been Sun's own shortcomings at Halol that have tripped up its finances.

Sun also had indicated it intends to pare down the combined manufacturing network. It already has notified workers at a plant in Ireland that intends to close a facility there. Now sources are telling the Economic Times that Sun is negotiating to sell two Ranbaxy plants in Hismanal Pradesh to an another Indian company. Sun declined to comment on the report.

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