Strides Pharma has announced that its step- down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for Ibuprofen Oral Suspension USP, 100 mg/5 mL from 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).

The product will be manufactured at the company’s facility in Bengaluru and will be marketed by Strides Pharma in the US market.

The company 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 around 60 commercialized products in the US and has set a target to launch around 20 new products every year from the combined portfolio.

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.

The company 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 in India (Chennai, Puducherry and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi) and the United States (New York).