Alembic Pharmaceuticals gains FDA approval for Icatibant Injection

Alembic Pharmaceuticals Limited has achieved a significant milestone with the US Food & Drug Administration’s (USFDA) final approval of its Abbreviated New Drug Application (ANDA) for Icatibant Injection, used in the treatment of acute attacks of hereditary angioedema (HAE) in adults. This approval marks the first peptide product approval for Alembic, showcasing their commitment to expanding their portfolio in critical care areas.

The approved Icatibant Injection, a 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, is therapeutically equivalent to Takeda Pharmaceuticals U.S.A., Inc.’s Firazyr Injection. With an estimated market size of US$ 112 million for the twelve months ending March 2024, according to IQVIA, this approval positions Alembic to capture a significant share of the HAE treatment market in the United States.

Headquartered in India, Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company that has been a prominent player in healthcare since 1907. The company is well-regarded for its extensive market presence globally, particularly in branded generics in India. Alembic’s manufacturing and research facilities meet stringent international standards, including those of the USFDA, affirming their capability in producing high-quality pharmaceutical products.

The approval process underscored Alembic’s expertise in developing complex generics, which involve navigating rigorous regulatory pathways and demonstrating bioequivalence to existing licensed medications. The Icatibant Injection approval is part of Alembic’s broader strategy to enhance its global footprint in the specialty pharmaceuticals market, focusing on diseases with significant unmet medical needs.

With this USFDA approval, Alembic Pharmaceuticals not only strengthens its product line but also reinforces its commitment to providing advanced therapeutic solutions globally. This strategic milestone is expected to bolster Alembic’s reputation as a reliable supplier of critical care medicines and enhance its competitive position in the global market.