Aurobindo Pharma Gets USFDA Nod for Estradiol Vaginal Inserts

On August 6, 2024, Aurobindo Pharma Limited announced that it had received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Estradiol Vaginal Inserts USP, 10 mcg. This product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VAGIFEM® 10 mcg, developed by Novo Nordisk Inc. The company plans to launch the product in Q2 FY25.

Estradiol Vaginal Inserts USP, 10 mcg, is used for the treatment of atrophic vaginitis associated with menopause. The approved product has an estimated market size of approximately USD 268 million for the twelve-month period ending June 2024, based on data from IQVIA.

With this latest approval, Aurobindo Pharma has now accumulated a total of 521 Abbreviated New Drug Application (ANDA) approvals from the US FDA, comprising 504 final approvals and 17 tentative approvals. This significant milestone further enhances the company’s extensive portfolio and reinforces its position in the pharmaceutical industry.

The introduction of Estradiol Vaginal Inserts will expand Aurobindo Pharma’s offerings in the women’s health segment and align with its strategy to bring essential therapeutic options to the market. The approval underscores the company’s commitment to providing high-quality, cost-effective medications to meet the needs of patients and healthcare providers globally.

In FY 2024, the company experienced a 16.7% increase in revenue from operations, increasing to ₹29,002 crore from ₹24,855 crore in FY 2023. Profit after tax (PAT) also grew by 64.3%, to ₹3,186 crore in FY 2024 from ₹1,939 crore in FY 2023.

About Aurobindo Pharma Limited 

Aurobindo Pharma Limited is a global pharmaceutical company based in Hyderabad, India. It is engaged in the development, manufacturing, and marketing a wide range of generic and branded speciality pharmaceuticals, as well as active pharmaceutical ingredients, in over 150 countries worldwide.

The company operates 29 manufacturing and packaging facilities that are approved by leading regulatory bodies, including the USFDA, EDQM, UK MHRA, WHO, Japan PMDA, South Africa MCC, Brazil ANVISA and Health Canada. Aurobindo Pharma’s extensive product portfolio spans seven major therapeutic areas: CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics, and Anti-Allergic. This is supported by a robust R&D infrastructure.

On August 7, 2024, the share price of Aurobindo Pharma Ltd opened at ₹1,416.60, touching the day’s high at ₹1,443.00, as of 10:46 AM on the NSE.

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