The inspection was carried out from 25 September 2024 to 04 October 2024, and concluded with five observations. The company is addressing the observations comprehensively and will respond to the U.S. FDA within the stipulated timeframe. Mumbai-based Lupin is an innovation-led transnational pharmaceutical company. It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The company's consolidated net profit jumped 76.01% to Rs 801.31 crore during the quarter as compared with Rs 452.26 crore posted in Q1 FY24. Revenue from operations increased 16.28% YoY to Rs 5,514.34 crore during the quarter. The scrip had advanced 0.65% to end at Rs 2197.60 on the BSE on Friday. Powered by Capital Market - Live

The inspection concluded with 3 observations on both the API and Finished Product sides. The pharmaceutical major is addressing these observations comprehensively and will respond to the USFDA within the stipulated timeframe. Mumbai-based Lupin is an innovation-led transnational pharmaceutical company. It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The company's consolidated net profit jumped 76.01% to Rs 801.31 crore during the quarter as compared with Rs 452.26 crore posted in Q1 FY24. Revenue from operations increased 16.28% YoY to Rs 5,514.34 crore during the quarter. Shares of Lupin gained 1.56% to end at Rs 2,221.50 on Friday, 27 September 2024. Powered by Capital Market - Live

Lupin informed that the U.S. FDA inspected Lupin's Pithampur Unit-1 API and finished product manufacturing facility from 16 September to 27 September 2024. The inspection closed with three observations each on the API and Finished Product side.Powered by Capital Market - Live

Lupin has allotted 5,893 equity shares under ESOP on 20 September 2024. Post allotment, the issued and paid-up capital of the Company has been increased to Rs 91,22,86,624 consisting of 45,61,43,312 equity shares of Rs 2/- each.Powered by Capital Market - Live

Vonoprazan is a novel potassium-competitive acid blocker (P-CAB). Unlike traditional acid suppressants like PPIs, Vonoprazan offers unique attributes like complete proton pump inhibition with the first dose, longer duration of action resulting in effective control of nocturnal acid breakthrough and meal-independent dosing. In India, Vonoprazan is approved by the Drug Controller General of India (DCGI) for treating reflux esophagitis, gastric ulcers, duodenal ulcers, and as part of Helicobacter pylori eradication treatment. The said drug will be marketed under the brand name Lupin's Lupivon and will be available in two strengths 10 mg and 20 mg. Under the terms of this agreement, Takeda has granted Lupin non-exclusive patent licensing rights to commercialize Vonoprazan in India. Rajeev Sibal, president India region formulations, Lupin,We are very pleased to commercialize Vonoprazan, a novel treatment option for Acid Peptic Disorders. This is a further step in strengthening our gastroenterology portfolio and is in line with our commitment to introduce innovative medicines to address unmet needs of our patients.' Mumbai-based Lupin is an innovation-led transnational pharmaceutical company. It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The company's consolidated net profit jumped 76.01% to Rs 801.31 crore during the quarter as compared with Rs 452.26 crore posted in Q1 FY24. Revenue from operations increased 16.28% YoY to Rs 5,514.34 crore during the quarter. The scrip declined 2.32% to Rs 2,217.85Powered by Capital Market - Live

Lupin announced that it has entered into a non-exclusive patent license agreement with Takeda Pharmaceutical Company (Takeda), to commercialize Vonoprazan Tablets in the Indian market. The drug will be marketed under the brand name Lupin's Lupivon' and will be available in two strengths - 10 mg and 20 mg. Under the terms of this agreement, Takeda has granted Lupin non-exclusive patent licensing rights to commercialize Vonoprazan in India. Powered by Capital Market - Live

Lupin Ltd rose for a third straight session today. The stock is quoting at Rs 2308.6, up 1.38% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is down around 0.06% on the day, quoting at 25182.65. The Sensex is at 82274.5, down 0.09%. Lupin Ltd has added around 20.82% in last one month. Meanwhile, Nifty Pharma index of which Lupin Ltd is a constituent, has added around 8.25% in last one month and is currently quoting at 23184.4, up 0.68% on the day. The volume in the stock stood at 10.3 lakh shares today, compared to the daily average of 18.32 lakh shares in last one month. The benchmark September futures contract for the stock is quoting at Rs 2309.25, up 0.88% on the day. Lupin Ltd is up 102.68% in last one year as compared to a 28.41% gain in NIFTY and a 52.01% gain in the Nifty Pharma index.The PE of the stock is 37.93 based on TTM earnings ending June 24.Powered by Capital Market - Live

Mirabegron extended-release tablets are used to treat the symptoms of an overactive bladder (OAB), such as incontinence (loss of bladder control), a strong need to urinate right away, or a frequent need to urinate. It is also used to treat neurogenic detrusor overactivity (NDO). The said drug is a generic equivalent of Myrbetriq extended-release tablets of Astellas Pharma Global Development, Inc. As per IQVIA MAT July 2024, Mirabegron extended-release tablets had estimated annual sales of $1,600 million in the U.S. Mumbai-based Lupin is an innovation-led transnational pharmaceutical company. It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The company's consolidated net profit jumped 76.01% to Rs 801.31 crore during the quarter as compared with Rs 452.26 crore posted in Q1 FY24. Revenue from operations increased 16.28% YoY to Rs 5,514.34 crore during the quarter. The scrip hit an all time high of Rs 2,280.95 in intraday today. Powered by Capital Market - Live

 Lupin announced the launch of Mirabegron Extended-Release Tablets, 50 mg, in the United States, after having received an approval from the United States Food and Drug Administration (U.S. FDA). Mirabegron Extended-Release Tablets, 50 mg is a generic equivalent of Myrbetriq' Extended-Release Tablets, 50 mg of Astellas Pharma Global Development, Inc. Mirabegron Extended-Release Tablets, 50 mg had estimated annual sales of USD 1,600 million in the U.S. (IQVIA MAT July 2024). Powered by Capital Market - Live

Lupin has allotted 1,21,150 fully paid-up equity shares of Rs 2 each under ESOP on 28 August 2024. With this allotment, the paid up equity share capital has increased to Rs 91,22,74,838 consisting of 45,61,37,419 equity shares of Rs 2/- each.Powered by Capital Market - Live