Shares of AstraZeneca Pharma Ltd were trading 2% higher on Friday, 30 May, on securing approval from the Central Drugs Standard Control Organisation (CDSCO). 

The company, in its regulatory filing, announced that it has received approval from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India, to import and sell Benralizumab 30 mg/ml solution for injection (brand name: Fasenra) for an additional indication.

In an exchange filing, AstraZeneca Pharma said, “This is to inform that AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India to import for sale and distribution of Benralizumab 30 mg/ml Solution for Injection (Brand name: Fasenra) for an additional indication.”

Benralizumab is used as an additional treatment for adult patients with recurrent or refractory eosinophilic granulomatosis with polyangiitis (EGPA).

Furthermore, the clearance allows for the sale of Benralizumab 30 mg/ml solution for injection (Brand name: Fasenra) in India for the indicated additional indication, subject to the receipt of any applicable statutory permissions. 

Earlier this week, AstraZeneca Pharma India received CDSCO approval to import and distribute Osimertinib Tablets 40 mg & 80 mg (TAGRISSO) for a new indication.

Osimertinib monotherapy is used in the treatment of patients with locally advanced, unresectable (stage III) NSCLC whose tumours exhibit EGFR exon 19 deletions or exon 21 (L858R) replacement mutations and whose illness has not progressed during or following platinum-based chemoradiation therapy.

AstraZeneca Pharma is a British-Swedish multinational pharmaceutical and biotechnology firm founded in 1999 by the merging of Sweden’s Astra AB and Britain’s Zeneca Group. 

The company is committed to researching and selling novel medications for a variety of therapeutic areas, including cancer, cardiovascular disease, gastrointestinal disorders, infections, neurology, respiratory conditions, and inflammation.

The corporation has had a significant presence in India for 45 years. AstraZeneca Pharma India oversees production, sales, and marketing operations, and the company has garnered global acclaim for its role in developing the Oxford-AstraZeneca COVID-19 vaccine.

At 3:30 pm, the shares of AstraZeneca closed 0.78% higher at Rs 7,980 on NSE.

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