Alembic Pharmaceuticals has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for the inspection conducted at its API-I and API-II facilities in Panelav, Gujarat. The inspection took place between May 26 and May 31, 2025.

In June 2025, the company also received an EIR for its API-III facility at Karakhadi, following a US FDA inspection carried out from March 17 to 21, 2025.

Alembic operates a wide network of manufacturing facilities, including five formulation facilities in Gujarat, one in Sikkim, and three API facilities in Gujarat.

Adding to its recent milestones, earlier this month, Alembic secured US FDA approval for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe. The product is indicated for the treatment of hypoprothrombinemia due to vitamin K deficiency or interference, as well as for the prophylaxis and treatment of vitamin K-deficiency bleeding in neonates.

With this latest approval, Alembic’s cumulative ANDA tally now stands at 225 approvals, comprising 204 final and 21 tentative approvals from the US FDA.