Metformin Bilayer, medicinal tablets manufactured by Sun Pharmaceuticals Industries Ltd., are photographed at company’s lab in Mumbai. (Photographer: Abhijit Bhatlekar/Bloomberg News)

Sun Pharma Gets First Drug Approval For Halol After Five Years

Sun Pharmaceuticals Industries Ltd. received first drug approval in five years for its Halol, Gujarat plant from the U.S. drug regulator after India’s largest drugmaker’s key facility was cleared last month.

The Food and Drug Administration has given the go-ahead for cancer injectable Infugem to be manufactured at the facility, the company said in an exchange filing.

The U.S. regulator first inspected the plant in September 2014. A subsequent warning letter in December 2015 meant that Sun Pharma couldn’t file for fresh drug approvals though it continued to export existing products made at the plant. After multiple inspections and observations, the U.S. FDA in June this year issued an Establishment Inspection Report, indicating that all issues raised by it had been addressed. That paved the way for fresh clearances. The company’s all niche future filings, including injectables, will come from the plant.

Shares of the drugmaker were trading 1.9 percent higher at 11:50 a.m. compared with a 0.1 percent decline in the Nifty Pharma Index.

The new drug will add to the drugmaker’s growing oncology portfolio of novel products. It had an addressable market size of about $35 million for the 12 months ended March 2018, the company said.

“We’re pleased to add this novel product to our expanding oncology portfolio as gemcitabine is one of the most commonly used cytotoxics in oncology practices,” Abhay Gandhi, chief executive officer, North America, at Sun Pharma, said in the statement.

Sun Pharma Gets First Drug Approval For Halol After Five Years

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