Risk Intelligence
USFDA observations at Bachupally facility
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Dr. Reddy's Q3 FY26 consolidated revenue grew 4.4% YoY to ₹8,727 crore, driven by double-digit growth in base business excluding lenalidomide and favorable forex. Reported EBITDA margin of 23.5% included a one-time provision for new labor law codes; adjusted margin was 24.8%. PAT declined 14% YoY to ₹1,210 crore due to lower lenalidomide sales and pricing pressure in US/Europe generics. India business grew 19% YoY led by innovative products, while emerging markets rose 32%. Management expects semaglutide launch in India on March 21, 2026, and Canada approval by May 2026. Biosimilar abatacept BLA filed in US with approval expected end-2026. Risk: USFDA observations at Bachupally facility may delay rituximab and denosumab approvals.
डॉ. रेड्डी की तीसरी तिमाही में कुल कमाई पिछले साल से 4.4% बढ़कर 8,727 करोड़ रुपये हो गई। यह बढ़ोतरी मुख्य कारोबार में मजबूत बिक्री और विदेशी मुद्रा के लाभ से हुई। कंपनी का मुनाफा 14% घटकर 1,210 करोड़ रुपये रहा, क्योंकि अमेरिका और यूरोप में दवाओं की कीमतें कम हुईं। भारत में कारोबार 19% बढ़ा, जबकि उभरते बाजारों में 32% की वृद्धि हुई। कंपनी मार्च 2026 में भारत में सेमाग्लूटाइड दवा लॉन्च करेगी और मई 2026 तक कनाडा से मंजूरी मिलने की उम्मीद है। अमेरिका में बायोसिमिलर दवा के लिए आवेदन किया गया है, जिसकी मंजूरी 2026 के अंत तक मिल सकती है। हालांकि, बाचुपल्ली कारखाने में जांच के कारण कुछ दवाओं की मंजूरी में देरी हो सकती है।
USFDA observations at Bachupally facility
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Read Transcript →India revenue grew 19% YoY driven by innovative products, new launches, and Stugeron acquisition.
Decline due to lower lenalidomide sales and price erosion in key products.
Robust growth driven by new product launches and favorable forex.
Management confirmed launch date for generic Ozempic in India.
Management expects India business to sustain double-digit growth of 15% or more, with potential upside from semaglutide and further BD.
USFDA issued a post-action letter for observations at the Bachupally biologics facility, potentially delaying rituximab and denosumab approvals.
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