Aurobindo Pharma’s shares surged nearly 2% after the company received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Estradiol Vaginal Inserts USP, 10 mcg. As of 9:30 AM, the shares were trading 1.63% higher at ₹1,424.45 on the NSE.
Key Highlights
- USFDA Approval: Aurobindo Pharma received final approval for Estradiol Vaginal Inserts USP, 10 mcg, which is bioequivalent and therapeutically equivalent to Vagifem, 10 mcg of Novo Nordisk Inc.
- Market Size: The approved product has an estimated market size of $268 million for the twelve months ending June 2024, according to IQVIA.
- Launch Timeline: The product is set to be launched in Q2 FY25.
Company Performance
Aurobindo Pharma’s recent financial performance has been strong:
- Q4 FY24 Net Profit: Jumped 79.5% to ₹908.75 crore compared to Q4 FY23.
- Revenue: Increased by 17.1% to ₹7,580.15 crore in Q4 FY24.
| Metric | Q4 FY24 | Y-o-Y Change (%) |
|---|---|---|
| Net Profit | ₹908.75 crore | 79.5% |
| Revenue | ₹7,580.15 crore | 17.1% |
Product Details
- Indication: Estradiol Vaginal Inserts USP, 10 mcg is indicated for the treatment of atrophic vaginitis due to menopause.
- Total ANDA Approvals: The company now has a total of 521 Abbreviated New Drug Application (ANDA) approvals from USFDA (504 final approvals and 17 tentative approvals).
Aurobindo Pharma, known for its extensive manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals, and related services, continues to strengthen its portfolio with this new approval.
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