Strides receives USFDA approval for Ursodiol Tablets

Mr. Arun Kumar, Founder and CEO, Strides Pharma Science Limited (Strides) -Photo By GPN

IMG_20200821_163801MUMBAI, 21 AUGUST, 2020 (GPN) – Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Ursodiol Tablets USP, 250 mg and 500 mgfrom the United States Food & Drug Administration (USFDA). The product is a generic version of Urso 250® Tablets, 250 mg and Urso Forte Tablets®, 500 mg, of Allergan Sales, LLC.

According to IQVIA MAT June 2020 data, the US market for Ursodiol Tablets USP, 250 mg and 500 mg is approximately US$ 35 Mn. The product will be manufactured at the company’s flagshipfacility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.

The company has 126 cumulative ANDA filings with USFDA of which 88 ANDAs have been approved and 38 are pending approval. ENDS

About Ursodiol Tablets

Ursodiol tablets are indicatedfor the treatment of patients with Primary Biliary Cirrhosis (PBC).

About Strides

Strides, listed on the BSE Limited (532531) and National Stock Exchange of India Limited (STAR), is a global pharmaceutical company headquartered in Bengaluru, India.The Company mainly operates in the regulated markets and has an “in Africa for Africa” strategy along with an institutional business to service donor-funded markets. The Company’s global manufacturing sites are located inIndia (Chennai, Puducherry and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi) and the United States (Florida). The Company focusses on “difficult to manufacture” products that are sold in over 100 countries. Additional information is available at the Company’s website at www.strides.com

About the Author

Sachin Murdeshwar
Sachin Murdeshwar is a Sr.Journalist and Columnist in several Mainline Newspapers and Portals.He is an ardent traveller and likes to explore destinations to the core.

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