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In a regulatory filing on Wednesday, Dr. Reddy’s Laboratories said it has received a Notice of Non-Compliance (NON) from Canada’s Pharmaceutical Drugs Directorate regarding its Semaglutide injection application, seeking additional information and clarifications. The company said it will respond promptly within the stipulated timeline and remains confident in the product’s quality, safety, and comparability.
Semaglutide, a popular diabetes and weight-loss drug, is the generic version of Ozempic, developed by Novo Nordisk.
The update weighed on shares of Shaily Engineering Plastics, which manufactures drug delivery devices, including Semaglutide pens, for Dr. Reddy’s. As per Shaily’s FY25 annual report, Dr. Reddy’s is among its top pharmaceutical clients.
During the first quarter of FY26, Shaily’s management had highlighted that the healthcare segment’s contribution to total revenue doubled to 31%, driven by rising demand for Semaglutide pens. To meet this demand, the company had installed 19 new injection moulding machines and a dedicated assembly and printing line, adding 25 million pens per annum in additional capacity.
The company also revealed plans to add another 25 million-pen line for a different Semaglutide variant, with a total capex of Rs 125 crore for FY26.
'We have 60% of generic market share on semaglutide across the markets that are opening up,' managing director Amit Sanghvi had said during the company’s Q1FY26 earnings call.
The delay in Dr. Reddy’s approval has raised concerns about potential near-term demand softness for Shaily’s key product line.
While the delay may impact short-term demand visibility for Shaily, analysts remain optimistic about the long-term growth prospects of Semaglutide-linked supplies amid booming global demand for GLP-1-based therapies. As per Shaily’s FY25 annual report, the global Semaglutide market, valued at $28.4 billion in 2024, is projected to reach $93.6 billion by 2035, growing at a CAGR of 10.5% on rising diabetes and obesity cases.
Profit before tax (PBT) stood at Rs 1,744.80 crore in Q2 FY26, down 9% year on year.
EBITDA for the quarter stood at Rs 2,351 crore, up 3% as against Rs 2 ,280 crore posted in Q2 FY25.
In its global generics business, North America contributed Rs 3,240.8 crore in revenue, a 13.07% year-on-year decline. Revenue from Europe surged 138.50% to Rs 1,376.2 crore, The India business generated revenue of Rs 1,578 crore, registering an 12.94% YoY.
Revenue from pharmaceutical services and active ingredients (PSAI) came in at Rs 944.99 crore, a 12.40% YoY increase.
In Q2 FY26, the company advanced its global presence through key acquisitions, product launches, and partnerships. It acquired the STUGERON portfolio across 18 APAC and EMEA markets for $50.5 million and launched Colozo (Linaclotide) and PCAB (Tegoprazan) in India.
Globally, it partnered with Unitaid, CHAI, and Wits RHI to make Lenacapavir affordable in 120 countries. Regulatory approvals were secured for Semaglutide in India, the denosumab biosimilar in Europe, and COVA 302 for ALS.
The company integrated two-thirds of its NRT business and launched Sacubitril Valsartan and fluorouracil cream in the US, as well as Skorolox in Russia, underscoring its focus on portfolio expansion and global market growth.
On a half year basis, the company’s consolidated net profit rose 7.84% to Rs 2,854.9 crore on 10.58% jump in revenue from operations to Rs 17,350.3 crore in H1 FY26 over H1 FY25.
Commenting on the results, Co-Chairman & MD, G V Prasad said: 'Growth in Q2 was driven by momentum in branded markets and steady contributions from the Nicotine Replacement Therapy (NRTJ portfolio, which helped offset the decline in U.S. Lenalidomide sales. We remain focused on strengthening our core business, advancing key pipeline assets, driving productivity and Pursuing business development initiatives.'
Hyderabad-based Dr. Reddy’s Laboratories is a global pharmaceutical company. It offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC.
Shares of Dr Reddys Laboratories rose 0.32% to close at Rs 1,284 on Friday, 24 October 2025.
Dr Reddys Laboratories Ltd rose for a third straight session today. The stock is quoting at Rs 1280.7, up 1.97% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is up around 0.62% on the day, quoting at 25868.3. The Sensex is at 84466.7, up 0.61%. Dr Reddys Laboratories Ltd has dropped around 1.59% in last one month.
Meanwhile, Nifty Pharma index of which Dr Reddys Laboratories Ltd is a constituent, has dropped around 0.17% in last one month and is currently quoting at 22253.75, up 0.68% on the day. The volume in the stock stood at 8.63 lakh shares today, compared to the daily average of 19.74 lakh shares in last one month.
The benchmark October futures contract for the stock is quoting at Rs 1280.5, up 1.68% on the day. Dr Reddys Laboratories Ltd is down 4.39% in last one year as compared to a 4.39% gain in NIFTY and a 3.11% gain in the Nifty Pharma index.
The PE of the stock is 15.21 based on TTM earnings ending June 25.
Dr Reddys Laboratories Ltd fell for a fifth straight session today. The stock is quoting at Rs 1233.4, down 0.1% on the day as on 13:19 IST on the NSE. The benchmark NIFTY is up around 0.12% on the day, quoting at 24664.4. The Sensex is at 80439.96, up 0.09%.Dr Reddys Laboratories Ltd has eased around 3.63% in last one month.Meanwhile, Nifty Pharma index of which Dr Reddys Laboratories Ltd is a constituent, has eased around 1.41% in last one month and is currently quoting at 21475.3, down 0.01% on the day. The volume in the stock stood at 14.52 lakh shares today, compared to the daily average of 13.62 lakh shares in last one month.
The benchmark September futures contract for the stock is quoting at Rs 1226.1, down 1.06% on the day. Dr Reddys Laboratories Ltd tumbled 8.62% in last one year as compared to a 4.39% slide in NIFTY and a 7.83% fall in the Nifty Pharma index.
The PE of the stock is 14.96 based on TTM earnings ending June 25.