Lupin Receives U.S. FDA Approval for Pithampur Unit-3 Facility

Lupin Limited , a global pharmaceutical leader, has announced a significant development in its regulatory compliance efforts. The company has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its Pithampur Unit-3 facility, marking a positive step in its manufacturing operations.

Inspection Details

The EIR was issued following a thorough inspection of the Pithampur Unit-3 facility, which took place from July 7 to July 17. This facility is crucial to Lupin's operations, as it manufactures a variety of pharmaceutical products including:

Metered dose inhalers
Dry powder inhalers
Topical formulations
Nasal solutions

Significance of the EIR

The receipt of an EIR is typically an indicator that the FDA has closed its inspection of the facility, finding it to be in an acceptable state of compliance with current good manufacturing practice (cGMP) regulations. This development is particularly important for Lupin, as it reinforces the company's commitment to maintaining high standards of quality and compliance in its manufacturing processes.

Management's Response

Nilesh Gupta, Managing Director of Lupin, expressed satisfaction with the outcome, stating, "We are pleased to have received the EIR from the U.S. FDA for our Pithampur Unit-3 facility. This demonstrates our commitment to maintaining the highest standards of compliance and quality, as we aim to deliver high-quality, affordable medicines from world-class factories for patients worldwide."

About Lupin Limited

Lupin Limited is a prominent player in the global pharmaceutical industry, with a significant presence in over 100 markets. The company specializes in:

Product Categories	Key Therapy Areas
Branded formulations	Respiratory
Generic formulations	Cardiovascular
Complex generics	Anti-diabetic
Biotechnology products	Anti-infective
Active pharmaceutical ingredients	Gastrointestinal
	Central nervous system
	Women's health

With 15 state-of-the-art manufacturing sites and 7 research centers globally, Lupin employs over 24,000 professionals. The company is also expanding its reach through subsidiaries such as Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

This latest regulatory approval underscores Lupin's ongoing efforts to ensure the highest standards of quality and compliance across its manufacturing facilities, reinforcing its position as a trusted provider of pharmaceutical products in the global market.

1 Day	5 Days	1 Month	6 Months	1 Year	5 Years
-2.08%	+0.50%	+0.94%	-4.56%	-9.72%	+113.27%

Lupin Limited 's subsidiary, Lupin Digital Health, has unveiled Vitalyfe™, an innovative AI-powered cardiometabolic wellness platform designed to address the growing heart health concerns among India's working professionals. This launch marks a significant step in Lupin's efforts to combine cutting-edge technology with healthcare solutions.

Key Features of Vitalyfe™

Vitalyfe™ leverages artificial intelligence, behavioral science, and computer-vision technology to offer personalized, non-medical interventions for improving heart health. Some of its notable features include:

Feature	Description
Heart Age Journey	Calculates heart age vs. chronological age and provides AI-guided steps for improvement
Snap & Track	AI-enabled, photo-based nutrition tool for easy calorie and macronutrient tracking
Camera-Guided Exercise	Uses computer vision to assess exercise quality and form accuracy
Guided Meditation Library	Offers techniques to lower stress and improve focus
Gamified Challenges & Rewards	Motivates users through team-based wellness challenges and milestone badges

Addressing a Critical Need

The launch of Vitalyfe™ comes at a crucial time, as studies indicate that up to 80.00 percent of India's corporate employees show early signs of hypertension and dyslipidemia. These conditions, often exacerbated by long work hours, chronic stress, and sedentary lifestyles, are silent accelerators of heart aging.

Rajeev Sibal, President of India Region Formulations at Lupin, emphasized the platform's importance: "Cardiometabolic risks silently erode both health and productivity. With Vitalyfe, we are enabling insurers and employers to combine clinical expertise with AI-driven technology to deliver scalable, measurable wellness outcomes for millions of working Indians."

Integration and Accessibility

Vitalyfe™ is designed to be integrated into corporate health benefits programs through insurers, brokers, and employers. This approach aims to improve employee productivity, engagement, and overall well-being while potentially reducing lifestyle-related insurance claims.

Sidharth Srinivasan, Chief Executive Officer of Lupin Digital Health, stated, "Our vision is to make cardiometabolic wellness both measurable and mainstream."

Data Privacy and Compliance

Lupin assures that Vitalyfe™ fully complies with India's Digital Personal Data Protection (DPDP) Act, is ISO 27001-certified, and ensures all user data is securely stored within India.

As organizations increasingly focus on employee health and well-being, platforms like Vitalyfe™ represent a growing trend in leveraging technology to address critical health issues in the workplace. The success of this initiative could potentially set a new standard for corporate wellness programs in India and beyond.