The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) and is used in the treatment of seizures.
The approval adds to a list of products that Strides has approved in this therapeutic category through the PEPFAR pathway taking the total to 15 products
The product is bioequivalent and therapeutically equivalent to the RLD, Vascepa of Amarin
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD)
Approval of this product under the PEPFAR program completes Strides’ qualification to all major markets and donor programs including Global Fund and South Africa
The products will be manufactured at the company's facility in Bengaluru
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.
The approval bolsters the company's Mycophenolate Mofetil portfolio
The USFDA had classified Strides Puducherry facility as OAI in May 2019 followed by issuing a warning letter to this site in July 2019.
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