Cipla USA Inc., the 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, 100 mg and 150 mg.

 

The drug is indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

 

The company said the product is set for an immediate launch through appropriate pharmacy and specialty distribution channels. 

Cipla’s Nintedanib Capsules are the generic therapeutic equivalent of Ofev, marketed by Boehringer Ingelheim. IPF is a chronic, progressive lung disease marked by irreversible scarring of lung tissue, leading to declining lung function and significantly impacting patient quality of life. 

Commenting on the approval, Marc Falkin 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.”

According to IQVIA MAT January 2026, Ofev generated approximately $3.76 billion in U.S. sales, highlighting the significance of the IPF therapy segment and the opportunity for high-quality generic alternatives. 

The approval further deepens Cipla’s respiratory footprint in the U.S., a strategic market where the company continues to expand its complex generics and specialty portfolio.