- Cipla USA Inc. the wholly owned subsidiary of Cipla Limited 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.