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 VitalDose Drug Delivery Platform has been used in patient-centric dose forms in women’s health for over two decades
The products will be manufactured at the company's facility in Bengaluru
Strides Pharma Science Limited to acquire 100% in Strides Pharma Services Pvt Ltd.
Biocon Biologics recently acquired the global biosimilars business of its long-term partner Viatris
The inspection classification was determined by the agency as Voluntary Action Indicated
Erythromycin tablets is used to prevent and treat infections in many different parts of the body
The facility has a potential for capacity expansion up to 2 billion tablets/capsules per year
The approval bolsters the company's Mycophenolate Mofetil portfolio
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