Lupin stock falls over 2% as Indore-based facility receives OAI classification from USFDA

As of 11:56 am, the stock was trading 1.89% lower at ₹1,936.30 per equity share.

This comes after the pharmaceutical’s Pithampur Unit-2 manufacturing facility received the 'Official Action Indicated (OAI) classification from the U.S. Food and Drug Administration (US FDA), it said in a regulatory filing dated Saturday.

An OAI classification indicates that a facility is in an unacceptable state of compliance, according to the US FDA website.

Furthermore, the US health regulator issued Form 483 with four observations after inspecting its Indore-based facility.

The US FDA inspected the facility from July 8 to 17, 2025, and ended the inspection with the issuance of Form 483, along with four observations, the Mumbai-headquartered pharmaceutical company added.

The drug manufacturer said that it is working with the health regulator to resolve the compliance issues satisfactorily, adding that it is committed to being compliant with CGMP (current good manufacturing practice) standards at all its manufacturing facilities.

Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and related Acts, as per the US FDA.

Additional developments

In a separate regulatory filing on Friday, the pharma major launched Liraglutide Injection, 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pen, in the United States. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older, with type 2 diabetes mellitus.

The Liraglutide Injection is a bioequivalent of Novo Nordisk’s Victoza Injection, 18 mg/3 mL (6 mg/mL), which had an estimated annual sale of $350 million in the US, according to IQVIA MAT Aug 2025 data.

On October 1, the company launched Rivaroxaban for oral suspension, 1 mg/mL, in the United States.

The drug is indicated for the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment. Additionally, it is also used in the treatment of thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure.

Rivaroxaban for oral suspension, 1 mg/mL, is bioequivalent to Janssen Pharmaceuticals’ Xarelto for oral suspension, 1 mg/mL, which had estimated annual sales of USD 11 million in the US, according to QVIA MAT July 2025.