Aurobindo Pharma Shares Fall After U.S. FDA Issues 10 Observations To Telangana Facility

The U.S. drug regulator has classified the unit as Official Action Indicated.

<div class="paragraphs"><p>A batch of medicine bottles at a Aurobindo Pharma plant. (Source: Company website)</p></div>
A batch of medicine bottles at a Aurobindo Pharma plant. (Source: Company website)

Shares of Aurobindo Pharma Ltd. eased after the U.S. Food and Drug Administration issued 10 observations after inspecting its facility in Telangana state.

The U.S. FDA inspected the company's Unit-IX at its facility in Telangana, from Nov. 10 through Nov. 18 and issued Form 483 with 10 observations.

Form 483 is issued when investigators have observed any condition that in their judgment may constitute violation of the Food Drug and Cosmetic Act and related acts.

"These observations are procedural in nature and not related to data integrity," the drug maker said in a stock exchange filing on Monday. It will respond to the U.S. FDA, within the stipulated timeline and shall work to address the observations at the earliest, Aurobindo said.

The U.S. drug regulator classified the unit as OAI or Official Action Indicated. This classification means that regulatory and/or administrative actions will be recommended, according to U.S. FDA website. Aurobindo said it has responded to the agency and carried out the required corrective actions.

Shares of the drug maker fell 1.26% to Rs 463.10 apiece as of 1:15 p.m., while the benchmark Nifty 50 eased 0.87% on the NSE.

Of the 32 analysts tracking the company, 24 maintain 'buy', six suggest 'hold' and two recommend 'sell', as per Bloomberg data. The 12-month consensus price target implies an upside of 30.6%.