| Strides Pharma Science (Strides) today announced that its 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 ~US$248 Mn per IQVIA. The product will be manufactured at the companyfs 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. |