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
Topiramate is the generic version of Supernus Pharmaceuticals’ Trokendi XR
Aurobindo's product is already filed with the Drugs Controller General of India (DCGI) and is expected to be approved soon
This is the 166th ANDA out of Eugia Pharma Speciality Group facilities
The product is being launched in August 2023
The approved product has an estimated market size of around US$ 210 million for the twelve months ending May 2023
This product would be manufactured at Lupin's Nagpur facility in India
This product will be launched through Granules Consumer Health (GCH) division
Alembic has a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.
Granules now has a total of 58 ANDA approvals from US FDA
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