MIRAMAR, Fla., Feb. 12, 2026 /PRNewswire/ — DifGen Pharmaceuticals, a leading US based generic pharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (USFDA) for its Fluorometholone Ophthalmic Suspension, 0.1% – a complex generic formulation used to treat eye inflammation. This is only the second generic USFDA approval of this complex suspension product.
“We are extremely proud that we received this first cycle approval, which marks a significant milestone for DifGen, demonstrating our expertise in developing complex ophthalmic suspension products with a high regulatory threshold for demonstration of therapeutic equivalence,” said Ramandeep Singh Jaj & Santhanakrishnan Srinivasan, Founders & Co-CEO’s DifGen Pharmaceuticals. “Our team has worked tirelessly to bring this challenging product to market, and their dedication reflects our commitment to enhancing patient access to essential treatments. This achievement highlights the importance of DifGen Pharmaceuticals in delivering innovative solutions for critical health needs.”
Fluorometholone Ophthalmic Suspension is a corticosteroid indicated for treating steroid-responsive inflammatory conditions of the eye’s anterior segment.
DifGen Pharmaceuticals is a USFDA-compliant manufacturer of generic pharmaceuticals, focused on developing complex formulations. At DifGen Pharmaceuticals, we lead in innovation, providing cost-effective solutions in complex generics and supply chain management to ensure access to essential medicines. Our diverse portfolio spans all dosage forms, backed by expertise in product development, quality assurance, manufacturing, and regulatory compliance. For more information please visit our website www.difgen.com.
Any questions regarding this press release should be directed to Roberta Loomar, Global General Counsel, at 409147@email4pr.com, 786-778-6820.
View original content:https://www.prnewswire.com/news-releases/difgen-pharmaceuticals-llc-receives-usfda-approval-for-fluorometholone-ophthalmic-suspension-0-1—expanding-its-complex-generic-portfolio-302686873.html
SOURCE DifGen Pharmaceuticals LLC
