The company is set to launch on an immediate basis

MUMBAI, India and WARREN, N.J., April 3, 2026 /PRNewswire/ -- Cipla USA Inc. the wholly owned subsidiary of Cipla Limited(BSE: 500087) (NSE: CIPLA) (hereafter referred to as "Cipla") today announced final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nintedanib Capsules, 100 mg and 150 mg, indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

Cipla's Nintedanib Capsules are the generic therapeutic equivalent of Ofev®, marketed by Boehringer Ingelheim. IPF is a chronic, progressive lung disease characterized by irreversible scarring of lung tissue, leading to declining lung function and significant impact on patients' quality of life.

Commenting on the approval Marc Falkin, CEO, Cipla North America, said, "This approval strengthens our respiratory franchise and reflects our continued commitment to delivering high–quality therapies to patients. We are well prepared with a robust supply plan to support a successful launch."

The product will be available through appropriate pharmacy distribution channels, including specialty distribution 

According to IQVIA, MAT January 2026, Ofev® generated approximately $3.76 billion in U.S. sales, underscoring the importance of reliable, high–quality treatment options in this category.

About Cipla Limited

Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, antiretroviral, urology, cardiology, anti-infective and CNS segments are well-known. Our 46 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT Dec'25), 2nd Largest in the pharma prescription market in South Africa (IQVIA MAT Nov'25), and 3rd largest by prescription in the US Gx (Repulses + MDI) products (IQVIA MAT Dec'25). For nine decades, making a difference to patients has inspired every aspect of Cipla's work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the HIV movement. A responsible corporate citizen, Cipla's humanitarian approach to healthcare in pursuit of its purpose of 'Caring for Life' and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. For more, please visit www.cipla.com, or click on Twitter, Facebook, LinkedIn.

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SOURCE Cipla USA Inc.