Lupin’s Indore Facility Fails To Clear Regulatory Test Again

Lupin Ltd. again received six observations from the U.S. health regulator for its Indore facility, a move that may cause disruption in supplies and delay future drug approvals.

The U.S. Food and Drug Administration awarded a Form 483—issued to a firm if investigators observe any conditions that in their judgment constitute violations of the U.S. Food Drug and Cosmetic Act and related acts—to the company's Pithampur Unit-II facility after an inspection conducted from Jan. 14-25, the Mumbai-based drugmaker said in an exchange filing.

Lupin, however, said it's confident of addressing the observations “satisfactorily”. The company's Indore facility makes Ophthalmics—used for treating eye disorders—and oral solids.

The company's Indore and Goa facilities had received warning letters in November 2017 after the U.S. FDA found that manufacturing practices were not adequate, leading to new approvals from the plant being withheld. The warning letters pointed to issues related to quality controls. These units together comprise nearly a third of Lupin's pending approvals.

Given that Lupin's U.S.-based business is facing pricing pressure, new drug launches are critical for its earnings growth. The company, however, will continue to supply its existing approved products.

Lupin, in a recently held JPMorgan Healthcare conference, indicated that it has made “significant progress” in resolving the issues in both these facilities.

Amey Chalke, a pharma analyst at HDFC Securities Ltd., said a clean-chit for Pithampur Unit-II facility is important for Lupin. It has held back important ophthalmic approvals for the company that could have aided the U.S. recovery, he told BloombergQuint. “But till the time we don't come to know the nature of observations, it's difficult to say whether the inspection will result in a resolution or status quo.”