Aurobindo Pharma receives US FDA approval for Ibuprofen OTC capsules

Ibuprofen is used to relieve pain from various conditions such as headache, dental pain, muscular aches, and minor pain of arthritis

Aurobindo Pharma has received final approval from the US Food & Drug Administration (US FDA) to manufacture Ibuprofen capsules OTC, 200mg. Aurobindo’s Ibuprofen capsules are a generic equivalent of Pfizer’s Advil Liqui-Gels Capsules. The product will be launched in Sep 2018.

Ibuprofen is used to relieve pain from various conditions such as headache, dental pain, muscular aches, and minor pain of arthritis. It is also used to reduce fever and to relieve from minor aches and pain due to the common cold or flu. The estimated market size of ibuprofen capsules OTC is $164 million for the twelve months ending March 2018, according to Nielsen data.

This is the 143rd ANDA (including 19 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India used for manufacturing oral products. Aurobindo now has a total of 373 ANDA approvals (340 Final approvals including 17 from Aurolife Pharma and 33 tentative approvals) from US FDA.