Lupin Expects U.S. Approvals From Goa Factory in Two MonthsBy
About a dozen $20 million to $30 million products are waiting
Clearance of Form 483 to take longer, managing director says
Lupin Ltd., India’s second-biggest drugmaker by market value, expects U.S. approvals for new products from its facility in the coastal state of Goa to begin again in the next two months as it addresses regulators’ concerns about manufacturing practices there.
The company has about a dozen new products ready for export to the U.S. from the Goa facility, each worth about $20 million to $30 million in revenue, that have been delayed, Managing Director Nilesh Gupta said in an interview in Mumbai. Lupin received an inspection report from the U.S. Food and Drug Administration earlier this year which noted several shortcomings around sanitation and operating procedures that had to be addressed.
"We’re hoping with the action plan that we’ve shared, with the meeting that we’ve had, with the updates that we’ve given them thereafter, I think they’ve hopefully seen enough to be convinced, OK, this is fine for now," Gupta said. "I’m hoping that in the next one or two months we’ll have clarity as far as the site is concerned. Clarity to me is product approvals."
The Indian pharmaceutical industry, source of 20 percent of the world’s generic-drug supply, has been rocked by increased scrutiny from U.S. regulators over the last two years. That has resulted in sanctions against some of the biggest firms that have restricted their access to the world’s most lucrative drug market.
The issues Lupin needs to fix were highlighted in the FDA’s Form 483, a less restrictive citation than a warning letter, so they don’t automatically trigger a ban on new drug approvals. Lupin has been sending the FDA responses to each of the criticisms over the last few months, but because Lupin won’t give its final response until December clearance of the Form 483 won’t come until after that, he said, adding approvals can still restart before that.
The U.S. FDA couldn’t immediately be reached for comment.
Lupin received about 42 percent of its revenue from the U.S. the last fiscal year. The stock is down about 20 percent this year. The stock rose 1.2 percent in Mumbai trading Friday to 1,485.65 rupees per share.
"It’s already affecting our existing business," Gupta said. "In this financial year we still expected more approvals from the near term in Goa than from any of our other sites."
Lupin has still been able to introduce new products from its other facilities. Thursday it became the first company to win approval for a generic version of Allergan Plc’s dementia drug Namenda, which will be produced from its Indore plant.
"We’d love to be able to launch some of the meaningful new products that are pending from Goa," Gupta said.