Strides Pharma Science Singapore arm gets USFDA okay for fibromyalgia drug Pregabalin

Bangalore: Strides Pharma Science Limited has announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Pregabalin capsules, 25 mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg. from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Lyrica capsules of Upjohn US. It is used in the treatment of fibromyalgia.

The Pregabalin capsules has a market size of ~US$248 Mn per IQVIA. The product will be manufactured at the company’s facility in Puducherry.

The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 235+ ANDAs have been approved.

"The company has set a target to launch ~ 60 new products over three years in the US," Strides stated.

Read also: Strides Pharma Science Singapore arm gets USFDA nod for Levetiracetam Oral Solution

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), Italy (Milan), Kenya (Nairobi) and the United States (New York).

Read also: Strides gets USFDA nod for Generic Suprep Bowel Prep Kit