Lupin gets inspection closure report from USFDA for Pithampur plant

Topics Lupin | USFDA

The USFDA issues an EIR to a company when an inspection is satisfactorily closed.
The US Food and Drug Administration (USFDA) has closed its inspection of Lupin's manufacturing facility in Pithampur, Madhya Pradesh, the company said on Thursday. The inspection for the facility was conducted by the US health regulator between February 3 and February 11, 2020, and concluded with two observations, the Mumbai-based company said.

The company has received the establishment inspection report (EIR) from USFDA for its Pithampur Unit-1 facility, Lupin said.

The USFDA issues an EIR to a company when an inspection is satisfactorily closed.

Lupin Managing Director Nilesh Gupta, said the company has received the EIR for the plant with Voluntary Action Indicated (VAI) status.

"Continuous improvement of our quality and compliance standards across all our manufacturing sites is a key focus area for the company and we are committed to working with the USFDA to manufacture and supply products of the highest quality from all our manufacturing sites," he added.

On Wednesday, the company announced that it received tentative approval for its Arformoterol Tartrate Inhalation Solution from the US drug regulator. The solution is indicated for the long-term maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD).

Following the development, Lupin shares gained 1.62% to Rs 868.10 before falling to Rs 823.



Business Standard is now on Telegram.
For insightful reports and views on business, markets, politics and other issues, subscribe to our official Telegram channel