Aurobindo Pharma’s arm receives USFDA’s final approval for Carboprost Tromethamine Injection

26 May 2023 Evaluate

Aurobindo Pharma’s wholly owned subsidiary company -- Eugia Pharma Specialties has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Carboprost Tromethamine Injection USP 250 mcg/mL, Single-Dose Vials, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Hemabate Injection, 250mcg/mL, of Pfizer Inc. The product is expected to be launched in June 2023. 

The approved product has an estimated market size of around $51.4 million for the twelve months ending March 2023, according to IQVIA. This is the 159th approved ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.

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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