Ranbaxy's Gurgaon unit might get to sell drugs in US

ANDA filed from the company's Gurgaon facility seeking approvals to sell generic medicines in the US

Ranbaxy Laboratories had filed applications seeking to sell drugs in the US made at its Gurgaon plant, which is not on among those barred by the the US Food and Drug Administration (FDA), according to a company executive who did not wish to be named.

“Ranbaxy has five manufacturing facilities in India that are registered with the FDA: Paonta Sahib, Mohali, Toansa, Gurgaon, and Dewas,” the US drug regulator’s spokesperson told Business Standard. Four of these are barred from supplying medicines to the US market but the Gurgaon plant is on the FDA approved list.

A Ranbaxy executive said Abbreviated New Drug Applications (ANDAs) were recently filed from the Gurgaon facility seeking the FDA’s approval to sell generic medicines in the US. “The FDA does not discuss communications with pharmaceutical companies,” the FDA spokesperson said when asked about Ranbaxy’s filings from its Gurgaon plant.

RANBAXY’S TROUBLED PAST

• 2006: US FDA issues warning letter to Ranbaxy's Paonta Sahib facility
• 2007: Whistle-blower's lawsuit alleges the firm defrauded Federal programmes
• Jun 2008: Daiichi Sankyo acquires a majority stake in Ranbaxy
• Sep 2008: US FDA imposes import alert on Ranbaxy's Paonta Sahib and Dewas factories; bans 30 drugs
• May 2013: Criminal charges filed; Ranbaxy agrees to pay a fine of $500 million
• Sep 2013: US bans imports from Ranbaxy’s new formulations factory in Mohali
• Jan 2014: US FDA bans imports from Ranbaxy's main API factory in Toansa
• Apr 2014: Sun Pharma acquires Ranbaxy in a $4-billion deal

Ranbaxy maintains it has “research and development centres in Gurgaon and no manufacturing facility”. It did not respond to queries on ANDA filings from Gurgaon. Sun Pharma, which is in the process of buying Ranbaxy, too, declined to comment on the Gurgaon facility and filings made from there.

Industry sources said Ranbaxy’s Gurgaon plant had a pilot manufacturing line and the company could it scale it up for commercial use if it secured product approvals from there. “Product approvals from India are important because the cost of manufacturing is much lower here,” an industry source who did not wish to be named said.

Ranbaxy’s three formulation manufacturing facilities at Paonta Sahib (Himachal Pradesh), Dewas (Madhya Pradesh) and Mohali (Punjab) face the FDA’s import alert. The US regulator has also barred supply of drugs from Ranbaxy’s active pharmaceutical ingredient manufacturing plant in Toansa (Punjab) to the US.

The FDA said Ranbaxy’s Gurgaon plant was not producing drugs for the US market. Ranbaxy has signed a consent decree with the FDA to undertake corrective measures in the other four plants. Ranbaxy, which was bought over by Mumbai-based Sun Pharma in a $4 billion deal in April, sells drugs in the US only manufactured at its New Jersey-based wholly owned subsidiary Ohm Laboratories.

Ranbaxy has some fat ANDA filings with potential “first to file” rights pending with the FDA that could earn significant revenue during the 180 days of exclusive sales in the world’s largest drug market. Though there is a delay in FDA approvals, the Ranbaxy management is confident about retaining sales exclusivity on its pending applications. Besides, the company indicated it recently filed applications for 10 new generic drugs with the FDA.

The FDA allows import of drugs from its approved plants and from units that make the ANDA filings.

During the quarter ended March 31, Ranbaxy posted Rs 770 crore sales in the US, up 19 per cent from a year ago. But the company’s sales in the US declined by $22 million from the previous quarter, mainly due to the ban on supplies from the Toansa facility. Observers are hopeful that under Sun Pharma’s management, Ranbaxy will resolve its regulatory issues in the US market.

On Wednesday, shares of Ranbaxy ended at Rs 460 on the BSE, up 0.89% from their previous close.