Strides Pharma Science’s arm gets USFDA’s nod for Mycophenolate Mofetil for Oral Suspension

30 Aug 2023 Evaluate

Strides Pharma Science’s step-down wholly owned subsidiary -- Strides Pharma Global, Singapore, has received approval for Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL, from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), CellCept for Oral Suspension, 200 mg/mL of Roche Palo Alto, LLC. (Roche). The approval bolsters the company's Mycophenolate Mofetil portfolio, which already includes numerous products in which the company is a market leader.

The Mycophenolate Mofetil for Oral Suspension has a market size of $41 million per IQVIA. The entire Mycophenolate Mofetil range of products for the company has a cumulative market opportunity of $145 million per IQVIA. The products will be manufactured at the company’s facility in Bengaluru. 

Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules. 


Strides Pharma Scien Share Price

874.85 -25.20 (-2.80%)
23-May-2024 15:31 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1494.95
Dr. Reddys Lab 5882.45
Cipla 1487.45
Zydus Lifesciences 1087.65
Lupin 1631.60
View more..
© 2024 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt.Ltd.