Glenmark Launching Sodium Bicarbonate Injection in the USA

Glenmark Pharmaceuticals Inc., USA will launch 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL) Single-Dose Vial. This product is bioequivalent and therapeutically equivalent to the reference listed drug. Distribution will begin in November 2025. The 8.4% Sodium Bicarbonate Injection, 50 mEq/50 mL (1 mEq/mL) market achieved annual sales of approximately $63.8 million.

New Product Launch

Glenmark Pharmaceuticals Inc., USA (Glenmark) is set to launch 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL) Single-Dose Vial. The launch is planned for November 2025.

Product Equivalence

Glenmark’s product is bioequivalent and therapeutically equivalent to the reference listed drug, 8.4% Sodium Bicarbonate Injection, 50 mEq/50 mL (1 mEq/mL), from Abbott Laboratories Pharmaceutical Products Division (Abbott) NDA – 019443.

Market Opportunity

The 8.4% Sodium Bicarbonate Injection, 50 mEq/50 mL (1 mEq/mL) market achieved annual sales of approximately $63.8 million (based on IQVIA® sales data for the 12-month period ending August 2025).

Company Statement

Marc Kikuchi, President & Business Head, North America, stated, “We are pleased to announce the expansion of our injectable portfolio to include the upcoming launch of 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL) Single-Dose Vial, which further reinforces our dedication to bring quality and affordable alternatives to market to patients in need.”

Source: BSE

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