DifGen Pharmaceuticals LLC, in Collaboration with Apotex Inc., Announces FDA Approval of Generic Nintedanib Soft Gel Capsules, 100 mg and 150mg Therapeutically Equivalent to Ofev®
PR Newswire
MIRAMAR, Fla., April 9, 2026
Partner Apotex Corp. (Apotex) to market and distribute to the U.S. healthcare market
MIRAMAR, Fla., April 9, 2026 /PRNewswire/ -- DifGen Pharmaceuticals LLC, a U.S.-based specialty generic pharmaceutical company today announced that its partner, Apotex Inc., has received final approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Nintedanib Soft Gel Capsules, 100 mg and 150 mg. The approved product is therapeutically equivalent (AB-rated) to the reference listed drug, Ofev®.
This approval represents a significant advancement in DifGen's expanding portfolio of complex generics and underscores the company's commitment to improving patient access to high quality, affordable pharmaceutical therapies across the United States.
"This milestone reflects DifGen's technical capabilities in developing complex soft gelatin drug products and the strength of our development and quality systems. We remain focused on executing a compliant and reliable commercialization strategy in collaboration with our partners., said Ramandeep Singh Jaj and Dr. Santhanakrishnan Srinivasan, Founders and Co-CEOs, DifGen Pharmaceuticals."
"Apotex looks forward to commercializing this important product for the American patient. The introduction of Nintedanib reflects our Journey of Health Strategy, which is focused on expanding treatment options and reducing barriers to care for patients who rely on essential therapies." We remain committed to supporting better health outcomes by ensuring that more people can access the medications they need," said Christine Baeder, President, Apotex U.S. and LATAM."
About DifGen Pharmaceuticals
DifGen Pharmaceuticals is a USFDA-compliant manufacturer of generic pharmaceuticals, focused on developing complex formulations DifGen specializes in complex generic drug development across multiple dosage forms, supported by integrated capabilities in product development, quality assurance, manufacturing, and regulatory compliance. For more information please visit our website www.difgen.com.
This Press Release contains forward–looking statements subject to risks and uncertainties.
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