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 ..
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Tushar Manudhane, Vipul Mehta, and Eshita Jain, research analysts at MOFSL, value Aurobindo Pharma at 16 times 12-month forward earnings, assigning a target price of ₹1,430
Technically, the term 'Golden Cross' has bullish implications with short-term support seen moving higher. Apart from Sun Pharma, Aurobindo Pharma and Divi's Labs too witnessed this formation recently.
On the daily chart, Nifty formed a bearish candle and continues to maintain a sequence of lower highs and lower lows for the fourth straight session indicating sustained pressure
Analysts noted that while US generics face margin headwinds, domestic formulations and CDMOs remain resilient. Biosimilars are also poised for growth through new launches and regulatory support.
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According to Nuvama, Aurobindo's Q2FY26 revenue and Ebitda were ahead of consensus estimates by 2 per cent and 1 per cent, respectively, though PAT missed expectations by about 5 per cent
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Pfizer-US trade deal triggers rally in pharma stocks. Nifty Pharma and BSE Healthcare index jumped 1 per cent each; while Nifty 50 and BSE Sensex advanced 0.1 per cent each in Wednesday's early trade.
Among individual counters, Sun Pharma slumped 4.87 per cent to a fresh 52-week low of ₹1,548, while Gland Pharma tumbled 4.70 per cent to ₹1,880. Biocon declined 3.68 per cent to ₹342.85.
Indian pharma shares - Dr.Reddy's, Cipla, Sun, Lupin and Aurobindo Pharma stare at up to 30 downside risk hint technical charts as US President Donald Trump announces 100% tariff on pharma imports.
Among stocks, Natco Pharma plunged 37.85%, Ipca Labs 22.43%, Aurobindo Pharma 17.99%, and Sun Pharma 14.30%. Other laggards include Lupin (13.25%), and Dr Reddy's (5.17%).
Stocks to watch today, September 8, 2025 | Aurobindo Pharma: USFDA issued 8 procedural observations after inspecting Telangana Unit-XII.
Analysts say Indian pharma firms will increase focus on non-US exports and the domestic market as US tariff threats persist, with firms exploring offshore manufacturing options
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Shortly after reports of the potential acquisition surfaced, Aurobindo clarified that no binding agreement or definitive decision has been made regarding the deal
Fresh launches boosted growth for players like Lupin, Torrent
Aurobindo Pharma's net profit fell 10.2 per cent Y-o-Y to ₹824 crore in Q1FY26, as against ₹918 crore in the same quarter last year
Aurobindo Pharma reports a 10.2% YoY drop in Q1 FY26 PAT due to lower API sales and US market revenue, while its European and growth markets continue to show positive momentum