Aurobindo Pharma’s wholly owned subsidiary -- Eugia Pharma Specialities has secured final approval from the US Food & Drug Administration (USFDA) to manufacture and market Everolimus Tablets, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg. Everolimus Tablets are bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Zortress Tablets, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, of Novartis Pharmaceuticals Corp. Everolimus Tablets are Indicated for the prophylaxis of organ rejection in adult patients (i) Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (ii) Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids.
This approval has been received from Eugia Unit-I and is expected to be launched in Q1FY27. This is the 184th ANDA approval (including 10 tentative approvals received) out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oncology 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.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1675.20 |
| Dr. Reddys Lab | 1235.40 |
| Cipla | 1238.30 |
| Zydus Lifesciences | 942.55 |
| Lupin | 2324.25 |
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