Aurobindo Pharma Faces Share Drop Amid USFDA Observations; Focuses on Global Expansion

16 Apr 2024 , 01:17 PM

Aurobindo Pharma witnessed a more than 2% decline in shares on Monday following the issuance of Form 483 by the USFDA to its Eugia Sterile unit. At the time of writing, on Tuesday, Aurobindo Pharma’s shares were trading 1.35% higher at ₹1101.10 apiece on the BSE.

The Form 483, based on an inspection from March 28 to April 5, outlined three critical observations regarding the unit’s operations.

The USFDA flagged concerns about procedural inadequacies to prevent microbiological contamination and the absence of verification processes for data accuracy at the plant.

Prompt action is expected from Aurobindo Pharma to address these observations, ensuring compliance with regulatory standards and maintaining manufacturing integrity.

Regulatory scrutiny will closely monitor the company’s response to the Form 483 observations, underscoring the importance of upholding quality and safety standards in the pharmaceutical sector.

Earlier in April, Aurobindo Pharma disclosed a USFDA inspection at its new injectable facility, managed by Eugia Steriles Private Ltd, which concluded with three observations.

Aurobindo Pharma recently received USFDA approval for mometasone furoate monohydrate nasal spray production, adding to its 507 ANDA approvals, comprising 488 final and 19 tentative approvals.

Aurobindo Pharma Limited is an Indian multinational pharmaceutical manufacturer with its headquarters situated in HITEC City, Hyderabad, India. The company specializes in producing generic pharmaceuticals and active pharmaceutical ingredients.

Aurobindo Pharma operates across six primary therapeutic and product domains, including antibiotics, anti-retrovirals, cardiovascular products, central nervous system products, gastroenterologicals, and anti-allergics. Its products are distributed in more than 125 countries, with marketing collaborations involving prominent names like AstraZeneca and Pfizer.

For feedback and suggestions, write to us at [e-mail]