Strides Pharma receives FDA approval for Ibuprofen suspension 

Bengaluru-based pharmaceutical company Strides Pharma has got the US Food and Drug Administration (USFDA) approval for Ibuprofen OTC Oral Suspension 50mg/1.25mL, strengthening Strides Ibuprofen franchise for the US markets.  

US market for the suspension is pegged at around $41 million and this product will be manufactured at the company’s facility at Bengaluru. Strides Pharma Inc will market the product in the American market, as per an exchange filing.  

Strides will have a 180 day competitive generic therapy (CGT) for the product under the relevant sections of the FD&C Act. The suspension is equivalent to Reference Listed Drug (RLD), Infants’ Advil Concentrated Drops, 50mg/1.25mL (40mg/mL) (OTC) of GlaxoSmithKline Consumer Healthcare.  

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used as a painkiller in conditions like headache, dental pain, menstrual cramps, muscle aches or arthritis. The drug is also used to relieve fever and reduce minor aches and pain due to flu or common cold.  

The pharma company currently has around 60 commercialised products in the US and has a target to launch approximately 20 new products every year from the combined portfolio.  

Strides has global manufacturing facilities in India in Chennai, Puducherry and two locations in Bengaluru. Besides this, it also has manufacturing facilities in Singapore, Italy’s Milan, Kenya’s Nairobi and US’ New York. Its products are sold in over 100 countries.