Aurobindo Pharma receives USFDA approval for Ibuprofen OTC Capsules

02 Jul 2018 Evaluate

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) 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 September 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 LLC and 33 tentative approvals) from USFDA.

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.

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