Drug Approval | October 04, 2023
Strides receives USFDA approval for Icosapent Ethyl capsules
The product is bioequivalent and therapeutically equivalent to the RLD, Vascepa of Amarin
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.
First release of Rs.166 crores incentives under PLI scheme for pharmaceuticals
The National Institute of Pharmacy and Nutrition, Hungary has issued 'Certificate of GMP Compliance of Manufacturer' for IOL Chemicals and Pharmaceuticals Limited's products.
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