Drug Approval | September 15, 2023
Strides receives tentative USFDA approval for Dolutegravir tablets
The products will be manufactured at the company's facility in Bengaluru
The products will be manufactured at the company's facility in Bengaluru
The company has received the Establishment Inspection Report (EIR) from the USFDA for the Pre-Approval Inspection (PAI) at a manufacturing site situated at Savli, Vadodara, Gujarat, with Zero 483 observations
The products will be manufactured at the company's facility in Bengaluru
Patients Treated with ARIKAYCE plus macrolide-based background regimen had meaningfully larger improvements in QOL-B respiratory score
Erythromycin tablets is used to prevent and treat infections in many different parts of the body
The approval bolsters the company's Mycophenolate Mofetil portfolio
Zinc Sulfate Injection is indicated in adult and paediatric patients as a source of zinc for parenteral nutrition
Glenmark's current portfolio consists of 184 products authorized for distribution in the U.S. marketplace
Zydus' Indomethacin suppositories also been granted 180-day CGT exclusivity to market this product.
The company through its IPO will fetch Rs 1475.26 crore - Rs 1550.59 crore at the lower and upper end of the price band.
Subscribe To Our Newsletter & Stay Updated
