Hyderabad-based Aurobindo Pharma Ltd on Tuesday (February 18) announced the completion of the US FDA pre-approval inspection (PAI) at Eugia Steriles Private Ltd, a 100% step-down subsidiary, located in Parawada Mandal, Andhra Pradesh. The inspection took place from February 10-18.
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“The United States Food and Drug Administration (US FDA) conducted a PAI at Eugia Steriles Private Limited (a 100% subsidiary of Eugia Pharma Specialities Limited and a step-down subsidiary of the Company), situated at Parawada Mandal, Anakapalli District, Andhra Pradesh, from February 10, 2025 to February 18, 2025,” Aurobindo Pharma said in a regulatory filing.
The inspection concluded with five procedural observations, which the company plans to address within the prescribed time. Aurobindo Pharma stated that it will update the stock exchanges with further developments if necessary.
Also Read: Aurobindo Pharma shares fall after USFDA issues 10 observations to API unit in Telangana
“The inspection concluded with 5 observations. The observations are procedural in nature and will be responded to within the stipulated time. We will keep the stock exchanges informed if there is any further information relating to the above in the future,” it said.
What is pre-approval inspection (PAI)?
The Food, Drug, and Cosmetic Act provides that the FDA may approve an NDA (New Drug Application) or an ANDA (Abbreviated New Drug Application) only if the methods used in, and the facilities and controls used for, the manufacture, processing, packing, and testing of the drug are found adequate to ensure and preserve its identity, strength, quality, and purity.
Q3 performance
Aurobindo Pharma’s net profit came in at ₹845.8 crore, marking a 9.7% decline from ₹936 crore reported in the same quarter last year. This was also lower than the CNBC-TV18 poll estimate of ₹906 crore, indicating weaker-than-expected bottomline performance.
Revenue, on the other hand, rose 8.5% year-on-year (YoY) to ₹7,978.5 crore, surpassing the CNBC-TV18 poll projection of ₹7,782.5 crore. The strong sales growth was supported by steady demand across key geographies, including the US and emerging markets.
Also Read: Aurobindo Pharma’s API unit in Telangana gets VAI status from USFDA
Operating performance remained subdued, with EBITDA falling 1.5% YoY to ₹1,627.7 crore, compared to ₹1,601 crore in the year-ago period. The number also came in below the CNBC-TV18 poll forecast of ₹1,636 crore.
Shares of Aurobindo Pharma Ltd ended at ₹1,162.55, down by ₹7.50, or 0.64%, on the BSE.
