Strides Pharma Science’s arm receives USFDA’s approval for Pregabalin Capsules

27 Jan 2024 Evaluate

Strides Pharma Science’s step?down wholly owned subsidiary---Strides Pharma Global, 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 $248 million 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 around 60 new products over three years in the US.

Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.


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