Aurobindo Pharma Ltd gets USFDA nod for $67 million drug

Aurobindo Pharma Ltd is in focus after receiving final USFDA approval for Perampanel Tablets in six strengths from 2 mg to 12 mg. The product has an estimated US market size of $67 million for the 12 months ended August 2026, according to IQVIA MAT data. The drug is bioequivalent and therapeutically equivalent to Fycompa Tablets, the reference product from Catalyst Pharmaceuticals. Aurobindo Pharma plans to manufacture the product through APL Healthcare and launch it in Q3 FY27. With this approval, the company’s total USFDA ANDA approvals have reached 599, including 574 final and 25 tentative approvals. Why it matters The approval strengthens Aurobindo Pharma’s US generics portfolio and provides another potential revenue opportunity. However, the $67 million market size is relatively small compared with the company’s overall business, so the immediate earnings impact may be limited. Technical view Aurobindo Pharma is trading around ₹1,681 on the daily chart. The broader trend remains positive as the stock is above the 50-day EMA at ₹1,645, 100-day SMA at ₹1,578 and 200-day SMA at ₹1,418. The key resistance zone is ₹1,695–₹1,705. A sustained breakout above ₹1,705 could open the way towards ₹1,750 and ₹1,800. Immediate support is at ₹1,660, followed by ₹1,645. A close below ₹1,645 could weaken the short-term trend. RSI is around 51, indicating neutral momentum, while ADX near 21 suggests moderate trend strength. MACD is showing some loss of short-term momentum. View: The USFDA approval is a positive fundamental trigger, but a sustained move above ₹1,705 would provide stronger technical confirmation. Disclosure: Neither I nor my family members hold any position in the mentioned stock at the time of publication.