Aurobindo Pharma’s arm gets USFDA’s final approval for Pemetrexed for Injection

26 May 2022 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 Pemetrexed for Injection, 100 mg, 500mg and 1000mg. Pemetrexed for Injection USP, 100 mg/vial and 500 mg/vial, Single-Dose Vials, to be bioequivalent and therapeutically equivalent to the RLD, Alimta for Injection, 100 mg/vial and 500 mg/vial of Eli Lilly. The product is being launched immediately. The approved product has an estimated market size of $ 1272 million for the twelve months ending March 2022, according to IQVIA.

This is the 139th 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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