Strides Pharma Science announced that its
step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received
approval for Ursodiol Capsules USP, 300 mg from the United States Food & Drug Administration
(USFDA).
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug
(RLD), Actigall Capsules, 300 mg, of Allergan Sales, LLC.
According to IQVIA MAT November 2020 data, the US market for Ursodiol Capsules USP, 300 mg is
approximately US$ 45 Mn. The product will be manufactured at the company s facility at Bengaluru and
will be marketed by Strides Pharma Inc. in the US market.
The company has 127 cumulative ANDA filings with USFDA of which 96 ANDAs have been approved
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The global ibuprofen market is projected to reach US$7.54 billion in 2024, progressing at a CAGR of 2.47%, over the period 2020-2024. The factors such as upsurge in healthcare expenditure, rising prevalence of arthritis, surging incidence of cancer cases, expanding urbanization and escalating sales of analgesic drugs would drive the growth of the market. However, the market growth would be challenged by adverse side effects and increase in the price of raw materials. A few notable trends include mounting e-commerce penetration, upswing in sports injuries, surging occurrence of chronic disorders and increasing public awareness.