_256_384.png)
The company plans a phased expansion across India, focusing initially on metro cities and early-adoption hubs
The company has supported the initiative since its inception, contributing to screening efforts in around 120 countries
The product is manufactured at AKUMS’ state-of-the-art injectable facility in Kotdwar, Uttarakhand
The submission is backed by positive results from the Phase 3 AFFIRM study
The lens received U.S. Food and Drug Administration (FDA) market authorization via the De Novo pathway in late 2025
India leads the shift as wellness tourism integrates healthcare, hospitality, and lifestyle
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis)
The first Phase III and second Phase III trials will be multi-centre, randomised, assessor-blind, active-comparator studies to determine the efficacy, safety and tolerability of orally administered Zintrodiazine
_256_384.jpg)
The approval makes Cipla’s product the first AB-rated generic therapeutic equivalent of Ventolin HFA
New appointments bring diagnostics and medtech expertise to strengthen healthcare delivery and policy engagement
Subscribe To Our Newsletter & Stay Updated
