_256_384.png)
The company plans a phased expansion across India, focusing initially on metro cities and early-adoption hubs
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis)
_256_384.jpg)
The approval makes Cipla’s product the first AB-rated generic therapeutic equivalent of Ventolin HFA
Aims to boost speed & precision in patient care
Approval for Albuterol Sulfate inhalation aerosol enables Cipla Limited to enter the $1.5 billion U.S. albuterol market
The newly approved pill combines 100 mg of doravirine with 0.25 mg of islatravir
If approved, the move would significantly broaden the use of KEYTRUDA and KEYTRUDA QLEX in combination with Padcev
A decision is expected by August 17, 2026 under the Prescription Drug User Fee Act timeline
Inspection outcome reinforces company's compliance track record and strengthens its ability to serve regulated markets including the United States
The approved product is a generic version of Ravicti, originally developed and marketed by Horizon Therapeutics
Subscribe To Our Newsletter & Stay Updated
