DifGen receives approval for the second generic to Adrenalin® Injection, further expanding its growing U.S. injectable portfolio

MIRAMAR, Fla., Sept. 16, 2026 /PRNewswire/ -- DifGen Pharmaceuticals LLC ("DifGen"), a US based specialty generic pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved its Abbreviated New Drug Application (ANDA) for Epinephrine Injection USP, 1 mg/mL, Single-Dose Vials. The approved product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Adrenalin® Injection, 1 mg/mL, (NDA 204200).

DifGen's product represents the second generic approval to the reference listed drug, providing an additional source of Epinephrine Injection USP, 1 mg/mL, Single-Dose Vials for the U.S. market.

Epinephrine is an important emergency medicine used in acute clinical settings. The approval represents another milestone in DifGen's strategy to build a differentiated portfolio of injectable products for the U.S. market, with a focus on medicines that are important to hospitals, healthcare providers and patients.

The approval further strengthens DifGen's growing U.S. portfolio and reflects the company's continued investment in the development and commercialization of complex and differentiated pharmaceutical products across multiple dosage forms, including sterile injectables.

DifGen's integrated approach brings together product selection, formulation and process development, regulatory execution, manufacturing and commercialization, with the objective of providing a reliable supply of high-quality medicines to the U.S. healthcare market.

About Epinephrine Injection USP

DifGen's Epinephrine Injection USP, 1 mg/mL is supplied in single-dose vials and has been approved by the U.S. FDA as bioequivalent and therapeutically equivalent to Adrenalin® Injection, 1 mg/mL, of PH Health Limited.

Please refer to the approved prescribing information for complete information regarding indications, dosage and administration, contraindications, warnings and precautions, and adverse reactions.

About DifGen Pharmaceuticals LLC

DifGen Pharmaceuticals LLC is a pharmaceutical company focused on the development, manufacturing and commercialization of high-quality pharmaceutical products for the U.S. and international markets. DifGen combines scientific development, regulatory capabilities, manufacturing and commercial execution to build a diversified portfolio across complex generics, specialty pharmaceuticals and differentiated dosage forms.

For more information about DifGen Pharmaceuticals LLC, please visit www.difgen.com.

Media & Business Inquiries

DifGen Pharmaceuticals LLC

Contact Person: Roberta Loomar

Title: Global General Counsel

Email: 422843@email4pr.com

Telephone: +19546051796

Adrenalin® is a registered trademark of its respective owner. DifGen Pharmaceuticals LLC is not affiliated with the owner of the referenced brand product.

Cision View original content:https://www.prnewswire.com/news-releases/difgen-pharmaceuticals-llc-announces-us-fda-approval-of-epinephrine-injection-usp-1-mgml-single-dose-vials-302880608.html

SOURCE DifGen Pharmaceuticals LLC