Thursday, August 31, 2023
Strides Pharma Science Limited (Strides) today announced that its step- down wholly owned subsidiary, Strides Pharma Global Pte. Limited, 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 ~US$41 Mn per IQVIA. The entire
Mycophenolate Mofetil range of products for the company has a cumulative market opportunity of ~US$145
Mn per IQVIA. The products will be manufactured at the company’s facility in Bengaluru.
The company has 280 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 260+ ANDAs have been approved. The company has set a target to launch ~ 60 new products over three years in the US.
About Mycophenolate Mofetil for Oral Suspension
Mycophenolate Mofetil for Oral Suspension belongs to a group of medicines called immunosuppressants. After a transplant, it is used with other medicines to prevent the body from rejecting an organ (such as a kidney, heart, or liver). It works by suppressing the body’s immune system so that it does not attack the new organ.
About Strides
Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE Limited (532531) and National Stock Exchange of India Limited (STAR). The Company mainly operates in the regulated markets and has an “in Africa for Africa” strategy and an institutional business to service donor- funded markets. The Company’s global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi), and the United States (New York). The Company focuses on “difficult to manufacture” products sold in over 100 countries. Additional information is available at the Company’s website at www.strides.com.
For further information, please contact:
Strides
Badree Komandur
Executive Director – Finance & Group CFO
+91 80 6784 0747
Strides Pharma Science Limited
CIN: L24230MH1990PLC057062
Regd. Office: 201, ‘Devavrata’, Sector - 17, Vashi, Navi Mumbai - 400 703
Corp. Office: Strides House, Bannerghatta Road, Bengaluru – 560076
