Therapeutically Equivalent to PENTASA®

MIRAMAR, Fla., March 11, 2026 /PRNewswire/ -- DifGen Pharmaceuticals LLC, a U.S.-based specialty generic pharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Mesalamine Extended-Release Capsules USP, 250 mg and 500 mg with a Competitive Generic Therapy (CGT) designation granted for the 250mg strength. The approved product is therapeutically equivalent (AB-rated) to the reference listed drug, PENTASA® (mesalamine) Extended-Release Capsules. This milestone marks DifGen's second consecutive first-cycle FDA approval for a complex generic ANDA — drawn from a robust, high-barrier pipeline that was set in motion since its inception.

This approval marks a significant addition to DifGen's growing portfolio of complex generics and reinforces the company's mission to broaden patient access to high-quality, affordable pharmaceutical therapies across the United States.

"When Santa and I founded DifGen, we envisioned 'Difficult and Differentiated Generics' - this approval and imminent launch brings that vision to life. We're proud to expand our portfolio, navigating complex regulatory pathways and bringing high-quality affordable treatments to patients."

—  Ramandeep Singh Jaj, Founder & Co-CEO, DifGen Pharmaceuticals

"This milestone highlights DifGen's strong scientific, clinical, and regulatory expertise in developing and securing approval of a complex product like Mesalamine that poses inherent pharmacokinetic challenges. Our scientific affairs team rose to this challenge by developing a robust manufacturing process and identifying stringent inclusion/exclusion criteria to manage the product's high inter-subject variability, low systemic absorption, and unpredictable bioavailability."

—   Dr. Santhanakrishnan Srinivasan, Founder & Co-CEO, DifGen Pharmaceuticals

About DifGen Pharmaceuticals

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.
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SOURCE DifGen Pharmaceuticals LLC