Aurobindo Pharma’s Hyderabad Unit Recieves Six Observations From U.S. Drug Regulator

Shares of Aurobindo Pharma Ltd. fell the most in five months after the U.S. drug regulator issued an inspection report with six observations for the company’s Bachupally manufacturing facility in Hyderabad.

The observations were made for procedural improvements, and none were related to data integrity, the drugmaker said in a stock exchange filing. The U.S. Food and Drug Administration conducted the inspection at the facility between April 10 and 18 and the company will respond to the observations as per the prescribed timelines, it said.

The U.S. market contributes nearly 45 percent of Aurobindo Pharma’s total sales. The Bachupally facility, called Unit III, is the company’s second most important plant in terms of the total number of drug filings after Unit VII (SEZ). Aurobindo Pharma had 16 tentative approvals from the U.S. Food and Drug Administration as of December 31, 2016, and 10 filings pending approval.

The drugmaker’s formulation manufacturing unit was issued a 'Form 483'. It’s issued to a company when the U.S. FDA completes an inspection and includes observations that could possibly violate the Food Drug and Cosmetic Act, according to the regulator's website.

Shares of Aurobindo Pharma dropped as much as 5 percent, but pared some gains to end 3.75 percent lower on the NSE. The benchmark Nifty 50 index ended almost unmoved.