Strides Pharma gets USFDA approval for Ibuprofen oral suspension

30 May 2022 , 08:58 AM

Strides Pharma Science (Strides) on Monday (30th May) announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for Ibuprofen oral suspension USP, 100 mg/5 mLfrom the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Motrin oral suspension, 100 mg/5 mL, of McNeil Consumer Healthcare (McNeil). Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu. According to IQVIA MAT March 2022 data, the US market for Ibuprofen oral suspension USP, 100 mg/5 mL is approximately about $66 million. Strides has 274 cumulative ANDA filings (including recently acquired portfolio from Endo at Chestnut Ridge) with USFDA of which 250 ANDAs have been approved and 24 are pending approval. The company currently has about 60 commercialized products in the US and has set a target to launch about 20 new products every year from the combined portfolio. Bengaluru-based Strides is a global pharmaceutical company. 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 companys global manufacturing sites are located in India (Chennai, Puducherry and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi) and the United States (New York). The drug maker reported a 36.6% decline in consolidated net profit to Rs 29.22 crore on a 4.7% fall in net revenue from operations to Rs 866.02 crore in Q4 FY22 over Q4 FY21. Shares of Strides Pharma Science rose 1.48% to Rs 326.60 on Friday, 27 May 2022. Powered by Capital Market – Live News