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AstraZeneca Pharma India has received import and market permission in Form CT-20 (marketing authorization) from the Drugs Controller General of India (DCGI) for Olaparib film-coated tablets 100 mg and 150 mg - additional indication.
Olaparib is additionally indicated as a monotherapy for treatment of adult patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene mutations (germline and/or somatic) who have progressed following a prior new hormonal agent.
The DCGI permission paves way for the launch of Olaparib in India for the specified additional indication, subject to the receipt of related statutory approvals and licenses.
AstraZeneca Pharma India is engaged in the discovery, development and commercialization of medicines for core areas of healthcare, including cardiovascular/metabolic disease, cancer and respiratory, inflammatory and autoimmune disease.
The company posted a 13.39% fall in net profit to Rs 18.63 crore in Q1 June 2020 from Rs 21.51 crore in Q1 June 2019. Revenue from operations stood at Rs 193.57 crore in Q1 June 2020, falling 5.3% from Rs 204.56 crore in Q1 June 2019.
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