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AstraZeneca Pharma India on Tuesday announced it has received regulatory approval to import and distribute Olaparib film-coated tablets (Lynparza) in 100 mg and 150 mg doses for a new indication.
The Central Drugs Standard Control Organisation (CDSCO) granted approval for its use in combination with Durvalumab for the maintenance treatment of advanced or recurrent endometrial cancer in adults whose disease has not progressed on first-line platinum-based chemotherapy, the company said in an exchange filing.
“AstraZeneca Pharma India Limited has received permission to import for sale and distribution in Form CT-20 from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India, for the additional indication of Olaparib film-coated tablets 100 mg and 150 mg (Lynparza),” the company said.
This approval is a significant milestone for the pharmaceutical firm, enabling it to launch Olaparib for this additional indication in India, pending further statutory clearances.
Market impact and company performance
Following the announcement, AstraZeneca Pharma India’s shares rose 1.98 per cent during intraday trading on Tuesday, reaching a high of Rs 6,583.65.
AstraZeneca Pharma, the Indian subsidiary of the British-Swedish multinational pharmaceutical giant, operates across several therapeutic areas, including oncology, cardiovascular diseases, and respiratory conditions. The company gained global prominence for its role in developing the Oxford–AstraZeneca Covid-19 vaccine.
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For the second quarter ending September 30, 2024, AstraZeneca Pharma India reported a 27 per cent year-on-year decline in net profit to Rs 38 crore, compared to Rs 52 crore in the same period last year. However, revenue from operations surged to Rs 408 crore from Rs 311 crore, reflecting strong operational performance despite lower profitability.
The latest approval is expected to bolster AstraZeneca Pharma India’s oncology portfolio further.
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