AstraZeneca Gets Approval from CDSCO for Osimertinib Tablets

AstraZeneca Pharma India Limited has received approval from the Central Drugs Standard Control Organization (CDSCO), which is part of the Indian Government’s Health Department. This approval allows the company to import and sell a medicine called Osimertinib Tablets (TAGRISSO) in 40 mg and 80 mg doses.

Purpose of the Approval

The approval allows Osimertinib to be used with 2 types of chemotherapy medicines, pemetrexed and platinum-based drugs, as the first treatment for patients with advanced or spreading non-small cell lung cancer. It is meant for patients whose cancer has specific genetic changes like EGFR exon 19 deletions or exon 21 L858R mutations.

Impact of the Approval

AstraZeneca is now allowed to market TAGRISSO for its newly approved use in India. However, the company still needs to secure other required government approvals before it can begin full-scale sales and distribution.

About the AstraZeneca Pharma India Limited

AstraZeneca Pharma India Limited is a leading biopharmaceutical company focused on discovering, developing and delivering innovative medicines. It operates mainly in the areas of oncology, cardiovascular, renal, metabolic and respiratory diseases. As part of the global AstraZeneca group, the company aims to improve the health of patients in India through advanced treatments and strong research-based solutions.

Share Price Performance 

As of April 07, 2025, at 11:00 AM, AstraZeneca Pharma share price is trading at ₹7,727.25 per share, reflecting a loss of 2.24% from the previous day’s closing price. Over the past month, the stock has registered a profit of 3.47%. The stock’s 52-week high stands at ₹9,059.05 per share, while its low is ₹4,800.15 per share.

Conclusion

This new approval is a major step for AstraZeneca in expanding its cancer treatment options in India. Once the remaining approvals are in place, TAGRISSO will offer a new line of treatment for many lung cancer patients with specific genetic changes, improving the availability of advanced cancer care in the country.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. This does not constitute a personal recommendation/investment advice. It does not aim to influence any individual or entity to make investment decisions. Recipients should conduct their own research and assessments to form an independent opinion about investment decisions.

Investments in the securities market are subject to market risks, read all the related documents carefully before investing.