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Aurobindo Pharma
Aurobindo Pharma on Thursday said the US health regulator has issued a Form 483 with five observations after inspecting Andhra Pradesh-based Unit-IV of its subsidiary APL Healthcare. The US Food and Drug Administration (USFDA) inspected the unit from December 8 to December 17, 2025, the Hyderabad-based drug firm said in a regulatory filing. "At the end of the inspection, a 'Form 483' was issued with 5 observations which are procedural in nature, and we will respond to the US FDA within the stipulated timelines," it added. The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe, the drug firm said. As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Shares of Aurobindo Pharma were trading 0.83 per ..
Aurobindo Pharma is currently incurring a loss at its China-based facility and expects the plant to achieve break-even by the end of the fiscal year, according to its CFO S Subramanian. The Hyderabad-based drug major remains confident about sustaining its growth momentum and driving value creation across all businesses, he said. "China (plant), as on date in the quarter, I will be incurring a loss of around maybe a million dollars, but, probably, we will be able to achieve the break-even between Q3 and Q4 and after that, China will start moving up in the overall contributing to the growth of the EBITDA growth," Subramanian said in an analyst call. The oral-solid-dosage (OSD) facility in China continues to ramp up, advancing towards the capacity of two billion, backed by European approval of ten products and three local product approvals, he stated. The site is on track to deliver EBITDA break-even by Q3-Q4 FY26, reinforcing its strategic importance to the global network, he added.
Aurobindo Pharma on Friday said a fire accident at Unit-IV of its wholly-owned arm APL Healthcare Ltd at Naidupeta in Andhra Pradesh has resulted in production disruption temporarily. In a regulatory filing, the company said on September 18, 2025, at around 8:50 am, a small fire incident occurred in granulation area-10 of Unit IV of APL Healthcare, situated at Naidupeta, Andhra Pradesh (SEZ Unit), due to a short circuit. The fire spread to a panel, affecting granulation area-10 and causing partial damage to granulation area-8. Out of the total 19 lines in the said Unit, 2 lines have been impacted for about two weeks, it added. The fire incident was immediately controlled through the in-house fire hydrant team, along with support from external fire tenders, and there were no casualties or injuries, the company said. "The incident resulted in a temporary production impact estimated at about 3 per cent of the monthly capacity of the said unit. Necessary steps have been initiated for .