AstraZeneca Pharma India gets CDSCO nod to import pharmaceutical formulations of Eculizumab
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-01-17 08:02 GMT | Update On 2025-01-17 08:02 GMT
Bangalore: AstraZeneca Pharma India Limited has received permission to import pharmaceutical formulations of new drug for sale or for distribution in Form CT-20 from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India, for Eculizumab concentrate for solution for infusion 300 mg (10mg/ml) (SOLIRIS).
Through this approval, Eculizumab is indicated for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) and atypical Hemolytic Uremic Syndrome (aHUS) to inhibit complement – mediated thrombotic microangiopathy.
The receipt of this permission paves way for the launch of Eculizumab Concentrate for solution for infusion 300 mg (10mg/ml) (SOLIRIS) in India for the above specified indications, subject to the receipt of related statutory approvals, if any.
Established in 1979, the Company is headquartered at Bengaluru, Karnataka in India and has a workforce of over 800 employees across the country.
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