AstraZeneca Pharma India has received import and market permission in Form CT-20 (subsequent New Drug Approval) from the Drugs Controller General of India for osimertinib 40mg/80mg film coated tablets (Tagrisso).
Osimertinib 40mg/80mg film coated tablets as monotherapy is now approved for additional indication for the adjuvant treatment after complete tumour resection in patients with non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.The receipt of this permission paves way for the launch of osimertinib 40mg/80mg film coated tablets into a new disease area in India, subject to the receipt of related statutory approvals and licenses, the company said in a statement.
AstraZeneca Pharma India's net profit declined 21.2% to Rs 21.05 crore in Q3 FY21 from Rs 26.7 crore in Q3 FY20. Net sales for Q3 FY21 stood at Rs 200.25 crore, a 10.5% fall over Rs 223.86 crore recorded in Q3 FY20.
Shares of AstraZeneca Pharma India fell 0.03% to close at Rs 3,415.55 on BSE yesterday, 10 March 2021. The Indian stock market is shut today (11 March 2021) on account of Mahashivratri.
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