Zydus Lifesciences gets OAI notice from US FDA, shares fall 3%

This fall in share price follows the company's Gujarat manufacturing facility receiving an official action indicated (OAI) classification from the United States Food and Drug Administration (US FDA).

As of 12:26 p.m., the company was trading at ₹1,159.05, down 2.24%.

The US drug regulator inspected Zydus's Jarod plant, a Gujarat-based injectable manufacturing facility, from 15 April to 23 April this year.

After an inspection, the US FDA classifies it by project area into one of three classifications. The OAI is the most stringent of the three. It means that "regulatory and/or administrative actions will be recommended".

The pharmaceutical major said in an exchange filing dated 18 July, "The company will work closely with the agency to resolve the regulatory status of this facility expeditiously."

Last week, the drugmaker touched a 52-week high at ₹1,203.20 on 11 July.

In a regulatory filing dated 19 July, the company revealed that it had received approval from the USFDA for its "New Drug Application (NDA)" to market ZituvimetTM XR (sitagliptin and metformin hydrochloride) extended-release tablets.