Cipla USA, a wholly owned subsidiary of Cipla Limited, has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nintedanib Capsules in strengths of 100 mg and 150 mg.

The drug is indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a progressive condition characterised by irreversible scarring of lung tissue that leads to declining lung function and reduced quality of life.

Cipla’s Nintedanib Capsules are the generic therapeutic equivalent of Ofev, originally marketed by Boehringer Ingelheim. The approval is expected to improve access to a critical therapy by offering a cost-effective alternative in the US market.

Commenting on the development, Marc Falkin, CEO of Cipla North America, said the approval reinforces the company’s commitment to expanding its respiratory portfolio and delivering high-quality treatment options to patients. He added that Cipla has a robust supply plan in place to support the product’s launch.

The medication will be distributed through specialty pharmacy channels, ensuring availability to patients requiring advanced respiratory care. According to IQVIA data (MAT January 2026), Ofev recorded approximately USD 3.76 billion in US sales, highlighting the significant demand for therapies addressing IPF.