India Pharma Outlook Team | Tuesday, 23 December 2025
Glenmark Pharmaceuticals, USA, has announced the commercial launch of its epinephrine injection USP, 30 mg/30 mL (1 mg/mL) multiple-dose epinephrine vial in the US pharmaceutical market. The product expands Glenmark’s hospital injectables portfolio and is approved as bioequivalent and therapeutically equivalent to the reference listed drug, epinephrine injection USP, 30 mg/30 mL (1 mg/mL), marketed by BPI Labs, LLC under NDA 205029.
The launch targets the institutional pharmaceutical products segment, particularly hospitals and emergency care providers, where epinephrine remains a critical medicine. According to IQVIA market data for the 12-month period ending October 2025, the epinephrine injection launch category recorded annual sales of approximately $67.6 million, indicating sustained demand for generic injectable drugs in regulated healthcare settings.
Epinephrine, commonly known as adrenaline, is widely used as an emergency care medicine for the treatment of severe allergic reactions, making it a key anaphylaxis treatment drug. It is also administered as a cardiac arrest medication and in cases of acute asthma and shock. In hospital environments, availability of multiple-dose formats supports efficient inventory management and rapid response during critical situations.
Glenmark’s newly launched product complies with stringent regulatory standards applicable to US FDA approved generics, reinforcing confidence among healthcare providers. The addition is expected to improve access while supporting cost control for institutions relying on consistent supply of critical care injectables.
Commenting on the development, Marc Kikuchi, President and Business Head for North America at Glenmark, said the launch strengthens the company’s footprint in the US generics market expansion strategy. He noted that the focus remains on delivering quality-assured medicines that meet hospital requirements without compromising affordability.
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The launch aligns with Glenmark’s broader strategy to scale its institutional pharmaceutical products business by expanding offerings in injectables and emergency therapies. By adding a therapeutically equivalent epinephrine injection, the company aims to support pricing competition and ensure dependable access to a medicine essential to emergency medical care across the United States.
