Last Updated on December 24, 2023 by The Health Master
USFDA approval
In a significant stride towards expanding its pharmaceutical portfolio, Strides Pharma Science has proudly announced that its subsidiary, Strides Pharma Global Pte. Ltd., located in Singapore, has gained USFDA approval from the United States Food & Drug Administration (USFDA) for its Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL.
USFDA approval: A Boost to Therapeutic Options
This USFDA approval holds immense importance as it marks a notable achievement for Strides Pharma Science.
Mycophenolate Mofetil for Oral Suspension USP, at a concentration of 200 mg/mL, has been deemed both bioequivalent and therapeutically equivalent to Roche Palo Alto’s Reference Listed Drug (RLD) CellCept for Oral Suspension, also at 200 mg/mL.
This commendable feat significantly bolsters the company’s existing Mycophenolate Mofetil portfolio, enhancing the range of treatment options available to patients.
Tapping into Lucrative Markets
With a market size valued at $41 million, as reported by IQVIA, mycophenolate mofetil for Oral Suspension holds a promising position in the pharmaceutical market.
Given that IQVIA estimated a staggering $145 million market opportunity for the entire Mycophenolate Mofetil product line, the product’s approval fits flawlessly with Strides Pharma Global’s strategic growth plans.
Manufacturing Excellence in Bengaluru
Strides Pharma Global’s commitment to quality extends to the manufacturing process as well.
The USFDA approval of Mycophenolate Mofetil for Oral Suspension will be expertly manufactured at the company’s state-of-the-art facility situated in Bengaluru.
This reflects the company’s dedication to maintaining high production standards while catering to the increasing demand for its pharmaceutical offerings.
A Proven Track Record of Success
The accomplishments of Strides Pharma Global speak volumes, with a cumulative count of 280 Abbreviated New Drug Application (ANDA) filings with the USFDA, which encompasses the recently acquired portfolio from Endo at Chestnut Ridge.
Impressively, the company has secured approvals for more than 260 of these ANDAs.
Building upon this success, Strides Pharma Global has set a commendable goal of launching a total of 60 new products within the span of three years in the highly competitive US market.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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