Strides Pharma gets USFDA nod for Ibuprofen oral suspension

10 Jun 2022 , 03:24 PM

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Infants Advil Concentrated Drops of GlaxoSmithKline Consumer Healthcare Holdings (US). The product approval further strengthens Strides Ibuprofen franchise for the US markets. 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. Strides was granted a competitive generic therapy (CGT) designation for its ANDA and is the first approved applicant for Ibuprofen oral suspension. It will have 180 days of CGT exclusivity for the product. The US over the counter (OTC) market for Ibuprofen oral suspension is approximately $41 million. The product will be manufactured at the companys facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market. The company has 274 cumulative ANDA filings (including recently acquired portfolio from Endo at Chestnut Ridge) with USFDA of which 251 ANDAs have been approved and 23 are pending approval. The company currently has 60 commercialized products in the US and has set a target to launch 20 new products every year from the combined portfolio. Strides Pharma Science 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&8208;funded markets. The company focusses on ?difficult to manufacture? products that are sold in over 100 countries. 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 were down 0.25% to Rs 314 on the BSE. Powered by Capital Market – Live News