Mylan NV

India’s pharmaceutical sector is calling on the US government to exclude generic drug imports from a sweeping national security investigation that could trigger major supply disruptions and price spikes. Industry leaders voiced their appeal during a recent meeting with Commerce Minister Piyush Goyal, warning that new US trade actions could threaten affordable medication access in both countries. The US has launched an inquiry under Section 232 of the Trade Expansion Act, 1962, targeting pharmaceutical imports and granting the President broad tariff powers if national security is deemed at risk. So far, medicines have been spared from a 50% tariff set to begin August 27, but uncertainty remains as India and the US negotiate a new bilateral trade pact. With Indian generics supplying a large share of America’s prescription market, experts warn that including these drugs in the probe could spark global shortages and volatility. The industry is urging policymakers to prioritize patient access and supply chain stability as trade tensions rise.

MAHWAH, N.J., Aug. 19, 2025 /PRNewswire/ -- Glenmark Pharmaceuticals Inc., USA (Glenmark) is pleased to announce the upcoming launch1 of Micafungin for Injection USP, 50 mg/vial and 100 mg/vial (Single-Dose Vial). Glenmark's Micafungin for Injection USP, 50 mg/vial and 100 mg/vial (Single-Dose Vial) is bioequivalent and therapeutically equivalent to the reference listed drug, Mycamine®2 for Injection, 50 mg/vial and 100 mg/vial, of Astellas Pharma US, Inc. NDA – 021506 and the company will begin distribution in September 2025. According to IQVIA® sales data for the 12-month period ending June 2025, the Mycamine® for Injection, 50 mg/vial and 100 mg/vial market3 achieved annual sales of approximately $60.7 million*. Commenting on the launch, Marc Kikuchi, President & Business Head, North America, said, "We are excited to announce the launch of Micafungin for Injection USP, 50 mg/vial and 100 mg/vial (Single-Dose Vial), growing our portfolio of products within the institutional channel, while also strengthening our commitment to bring quality and affordable alternatives to market for patients in need." 1 Glenmark's Micafungin for Injection USP, 50 mg/vial and 100 mg/vial (Single-Dose Vial) is only approved for the indication(s) listed in Glenmark's approved label. 2 All brand names and trademarks are the property of their respective owners. 3 Market includes brand and all available therapeutic equivalents. Note: IQVIA® data obtained by Glenmark is only available for all approved RLD indications. Glenmark's product is only approved for the indications listed in Glenmark's approved label and is not marketed for all RLD indications. *IQVIA® National Sales Perspectives: Retail & Non-Retail, June 2025 About Glenmark Pharmaceuticals Limited Glenmark Pharmaceuticals Ltd. (BSE: 532296) (NSE: GLENMARK) is a research-led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 11 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries. In Vivo/Scrip 100 positions Glenmark amongst the Top 100 Companies Ranked by R&D and Pharmaceutical Sales, 2022; while Generics Bulletin/In Vivo places it in the Top 50 Generics and Biosimilars Companies Ranked by Sales, 2022. Glenmark's Green House Gas (GHG) emission reduction targets have been approved in 2023 by the Science Based Target initiative (SBTi), making it only the second pharmaceutical company in India to achieve this. The organization has impacted over 3 million lives over the last decade through its CSR interventions. For more information, visit . You can follow us on LinkedIn (Glenmark Pharmaceuticals) and Instagram (glenmark_pharma). Logo: SOURCE Glenmark Pharmaceuticals Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

New Delhi: Ahmedabad based drugmaker Zydus Lifesciences is progressing to introduce market-specific dosage strengths of its Semaglutide formulations, expected to be launched over the next 1 to 2 years time, said Dr Sharvil Patel, MD, Zydus Lifesciences Ltd. Speaking at the company’s Q1 FY26 earnings call, Dr Sharvil Patel said, “along with India, we will take our formulations to other markets and our strategy is to enter with not the same but differentiated formulations across all markets and regulatory filings will begin by the end of the year, and we expect product launches within 1–2 years, depending on the duration of the approval process.” “We are quite excited with our novel formulation which offers significant benefit versus the existing formulation in the market and from the commercialisation point of view India will generate the highest revenue for us,” he added. Commenting on the capacity to meet demand in Canada and India, where the market is expected to open by March, the MD said, “The company has sufficient capacity and alternate sources, and the device (pen) is also planned.” “We are fully integrated to offer both backward–API and forward–finished formulation,” he noted. Notably, earlier reported by the Economic Times, Zydus has been working on a pen device which can deliver “adjustable doses”, thereby potentially eliminating the requirement of separate pens. Semaglutide, marketed by Danish drugmaker Novo Nordisk under the brand name Wegovy for weight-loss and Ozempic for type-2 diabetes is available as a prefilled pen where each pen is for one-time use only and comes with a preset dose. Wegovy(Semaglutide) marketed by Danish drugmaker Novo Nordisk comes in five strengths 0.25 mg, 0.5 mg, 1 mg, 1.7 mg and 2.4 mg, followed in the same order for prescription from 1 to 5 months. While, its rival Tirzepatide marketed by US-giant Eli Lilly under the brand name Mounjaro is available under two dosage strengths 2.5 mg and 5 mg. Novo Nordisk blockbuster therapy is set to lose its exclusivity in Canada and India by early 2026, potentially triggering a wave of generic competition involving Indian drugmakers. According to PharmaTrac data as of July this year, Semaglutide has a market size of Rs 421 crore and its injectable brand Wegovy reported total sale of Rs 10 crore since its launch in June. MedTech foray outlook From a India perspective we have become an important device player, following the acquisition of a majority stake ( 85.6 per cent stakes for €256.8 million) in France-based Amplitude Surgicals, an implant and robotic technology maker, said Dr Patel. We expect the company's robotic-arms business to improve our revenue in Europe and will launch the products in some other markets including India as well, he outlined. Tariffs tension Over the looming uncertainty of tariffs from the US administration, Dr Patel said, “While US is an important market for the US, there is no clarity, as currently expected for the industry and once they come into play we will analyse the impact and work accordingly to achieve the best after that.” “Generics play a crucial role in the US healthcare system and account for nearly 90 per cent of the total drugs volume that ensures savings, affordability and we are committed to ensure this access in the US," he added. Q1 FY26 results For the April-June quarter the drugmaker reported a revenue of Rs 6,573 crore, up by 5.9 per cent on year-on-year (YoY) basis. However the company’s net profit remained muted with a marginal increase of 1.1 per cent YoY to Rs 1,466 crore. The quarter’s Earnings Before Interest, Taxes, Depreciation, and Amortisation (EBITDA) stood at ₹2,088 crore at a margin of 31.8 per cent, down by the previous fiscal same quarter margin of 33.6 per cent. Non-US international sales reported the highest segmental YoY growth of 36.8 per cent with a revenue of Rs 726.5 crore while the US business remained muted with a marginal increase of 2.9 per cent to Rs 3,181 crore. “For the full fiscal in the US, despite the pricing pressure in Revlimid—a cancer drug—we maintain our existing guidance,” said Dr Patel. In India the company's formulations sales generated Rs 1,519 crore while its consumer wellness segment reported a revenue of Rs 854.9 crore. By Abhijeet Singh ,