India's Aurobindo Pharma eyes major earnings boost if U.S. FDA comes through on applications

SINGAPORE--Aurobindo Pharma's U.S. unit AuroMedics Pharma USA says that if the U.S. FDA manages to speed up its approval process for generic drugs in the coming fiscal year, its earnings could shoot up by half.

"We will probably grow in the 40% to 50% range for the coming fiscal, provided we get the approvals," President Ronald Quadrel told analysts in a discussion about third-quarter earnings.

Quadrel said the company had 45 applications related to generic drugs pending before the agency and had expected about 20 of them to be cleared for marketing in the upcoming fiscal year, the rest the following fiscal year.

But he and CEO Robert Cunard chastised the FDA for its slowness in reviewing drug applications. Cunard said, "The FDA continues to be a challenge as far as approval timelines," reported the India newspaper, DNA India.

In the third-quarter filing, the unit reported a net profit decline of 7.93%, but blamed higher costs for raw materials for much of the decline.

For the near future, Quadrel appeared to be more concerned about the U.S. FDA and said its slowness made it difficult to predict when the company would get approvals. But he said he does expect approvals of its larger products late in the next fiscal year, possibly meaning about this time next calendar year.

Sounding more upbeat, he said, "We will see full-year growth on the products that are getting approved this coming year, which is the smaller products." According to a broker firm, those "smaller" items consist primarily of injectables.

- read the DNA India story

Suggested Articles

Johnson & Johnson faces a litany of problems, but executives are clearly not concerned—at least not about the company's short-term fortunes.

This week, Goldman Sachs resurrected a burning question: How can pharma companies profit from curing patients with one-time gene and cell therapies?

CMS has determined how it'll pay for Gilead's CAR-T cancer therapy, Yescarta, for outpatient use, but hasn't yet decided on Gilead's…