AstraZeneca Pharma India Ltd. has secured approval from the Central Drugs Standard Control Organisation (CDSCO) to import Eculizumab (Soliris), a new drug indicated for the treatment of rare blood disorders.

The company disclosed the approval in a regulatory filing to the Bombay Stock Exchange (BSE) and the National Stock Exchange (NSE).

Eculizumab is a monoclonal antibody used to treat Paroxysmal Nocturnal Hemoglobinuria (PNH) and Atypical Hemolytic Uremic Syndrome (aHUS) by inhibiting complement-mediated thrombotic microangiopathy. This approval, granted in Form CT-20, allows AstraZeneca to import the drug for sale and distribution in India.

The approval marks a significant step in expanding treatment options for patients suffering from these rare conditions. However, the commercial launch of Eculizumab (Soliris) 300 mg (10mg/ml) concentrate for infusion in India remains subject to further statutory approvals.

AstraZeneca Pharma India expressed its commitment to bringing advanced therapies to Indian patients.

"This approval paves the way for us to introduce Eculizumab in India, addressing an urgent need for advanced treatment in rare hematological diseases," the company stated in its regulatory filing.

The market response to the approval has been positive, with AstraZeneca Pharma India’s stock reflecting investor optimism about the drug’s potential impact in the Indian pharmaceutical landscape.