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Aurobindo Pharma Shares Rose 2% USFDA Approval for Nasal Spray

The US regulatory closed the inspection with three procedural observations.

Aurobindo Pharma Limited Shares share price surged as much as 2% in the early trade on March 20 after the company received US Food & Drug Administration (USFDA) approval for nasal spray.

According to the company’s recent regulatory filing, the company received the final approval to manufacture and market Mometasone Furoate Monohydrate Nasal Spray, 50 mcg/spray, being bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nasonex Nasal Spray, 50 mcg/spray of Organon LLC.

This approval is received from the US Food & Drug Administration (USFDA), and the product will be launched in the first quarter of the financial year 2025.

The approved product has an estimated market size of USD 44.5 million for the twelve months ending January 2024, according to IQVIA. Aurobindo then has a total of 507 ANDA approvals from USFDA – 488 Final approvals and 19 tentative approvals.

Mometasone Furoate Monohydrate Nasal Spray, 50 mcg/spray, is indicated for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis in adults and paediatric patients 2 years of age and older.

The company develops, manufactures, and commercialises a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad, India.

The company has 25 manufacturing and packaging facilities that are approved by leading regulatory agencies, including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA.

The company’s robust product portfolio is spread over 7 major therapeutic/product areas which comprises CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.

However, at 10:36 am, the shares of Aurobindo Pharma were traded flat at Rs 997.10 on NSE.

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