Glenmark Pharmaceuticals Ltd.

Mumbai: Glenmark Pharmaceuticals Monroe facility has received five observations under the Form 483 from the US Food and Drug Administration ( FDA ). In an intimation to the stock exchange the drugmaker announced that, "the regulator conducted a GMP inspection at the company’s manufacturing facility in Monroe, North Carolina, USA from June 9 to 17 and issued a Form 483 with five (5) observations.” While the company did not disclose the nature of observations as per the stock exchange filing there was no observation related to data integrity reported and all the observations are procedural in nature. “We will work in close collaboration with the agency to address the observations and will respond to the FDA within the stipulated timeline, the company added. An observation under the Form 483 is issued if the FDA observes that certain conditions may violate the Food, Drug, and Cosmetic (FD&C) Act or related laws. However, the observations are early warning of potential compliance issues and allow the company to address them before further regulatory action is considered. By Online Bureau ,

New Jersey: Indian drugmaker Glenmark Pharmaceutical US arm has launched Olopatadine Hydrochloride Ophthalmic Solution , an OTC medication for the treatment of allergic rhinoconjunctivitis . . The launched medicine is bioequivalent to Pataday (once Daily Relief) Ophthalmic Solution, of Alcon Laboratories . Citing Nielsen syndicated data the company noted that, for the latest 52-week period ending May this year Pataday had an estimated annual sales of around $50 million (around ₹425 crore). Commenting on the launch, Marc Kikuchi, President & Business Head, North America said, “We are excited to announce this launch and address the growing demand for a new supplier in this category. This addition highlights our commitment to meeting market needs and providing high-quality over-the-counter solutions for our customers.” By Online Bureau ,

MAHWAH, N.J., June 16, 2025 /PRNewswire/ -- Glenmark Therapeutics Inc., USA (Glenmark) is pleased to announce the launch1 of Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC); compared to the active ingredient in Pataday®2 Once Daily Relief. According to Nielsen® syndicated data for the latest 52-week period ending May 17, 2025, the Pataday® Once Daily Relief (OTC) market3 achieved annual sales of approximately $50.0 million*. Commenting on the launch, Marc Kikuchi, President & Business Head, North America said, "We are excited to announce the launch of Olopatadine Ophthalmic Solution USP, 0.2%, addressing the growing demand for a new supplier in this category. This addition highlights our commitment to meeting market needs and providing high-quality over-the-counter solutions for our customers." For product information and how to purchase, please visit: . About Glenmark Pharmaceuticals Ltd. 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. Scrip 100 positions Glenmark amongst the Top 100 biopharmaceutical companies ranked by Pharmaceutical Sales in 2023; while Generics Bulletin places it in the Top 50 Generics and biosimilar companies ranked by sales in 2024. 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 3.3 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). References 1 Glenmark's Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC) is only marketed for the indications listed in Glenmark's approved drug facts label. 2 This product is not manufactured or distributed by Alcon Laboratories, Inc., distributor of Pataday® Once Daily Relief, and/or Novartis AG, owner of the registered trademark Pataday®, respectively. [Neither Alcon nor Novartis make or license Glenmark's product.] 3 Market includes brand and all available therapeutic equivalents. Note: Nielsen syndicated 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. *Nielsen® NIQ Discover; Syndicated Data for Period Ending May 17, 2025 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