New Delhi: Aurobindo Pharma has received final approval from the US health regulator to manufacture and market Ibuprofen capsules, used to relieve pain and reduce fever.
The approved product is a generic equivalent of Pfizer’s Advil Liqui-Gels Capsules. The product will be launched in September 2018.
“The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture Ibuprofen capsules OTC, 200 mg,” Aurobindo Pharma said in a BSE filing.
Quoting Nielsen data, Aurobindo Pharma said the estimated market size of ibuprofen capsules OTC is USD 164 million for the twelve months ending March 2018.
The pharma company said it has now a total of 373 ANDA (Abbreviated New Drug Application) approvals (340 final approvals, including 17 from Aurolife Pharma LLC and 33 tentative approvals) from the USFDA.