The TWYMEEG approval is supported by numerous preclinical and clinical studies, including the Phase 3 TIMES (Trials of IMeglimin for Efficacy and Safety) program managed jointly by both the companies
In an exclusive interview with Rahul Koul of Indian Chemical News, Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals Inc. USA shared details about the company's performance, R&D initiatives, Capex plan, CSR, and future outlook. Excerpts of the interview:
The study was conducted in patients with mild to moderate COVID-19
The company is doubling its chemistry research capacity that should commission by Q2'FY22
For undertaking production, the company has been provided a Rs. 65 crore grant by the centre and Rs. 94 crore from the government of Maharashtra
Dr. Sharvil Patel cites the example of prescriptions being handed over to patients despite unavailability of enough stock of such medicines
The trial met its pre-specified primary endpoint, demonstrating that PDP-716 dosed once daily is equivalent to Alphagan P 0.1% dosed 3 times a day
It reported total income of Rs.15299.25 crores during the FY ended March 31, 2021
The drug accumulates in the virus infected cells and prevents virus growth by stopping viral synthesis and energy production
Both the vaccines have been extensively tested by IVRI for safety and potency and have been found to provide 100% protection
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