The product has been deemed bioequivalent and therapeutically equivalent to the reference listed drug, 8.4% Sodium Bicarbonate Injection, 50 mEq/50 mL (1 mEq/mL) of Abbott Laboratories Pharmaceutical Products Division (NDA - 019443).
Glenmark plans to begin distribution in November 2025, further strengthening its injectables portfolio in the US market.
According to IQVIA sales data for the 12-month period ending August 2025, the market for 8.4% Sodium Bicarbonate Injection, 50 mEq/50 mL (1 mEq/mL) achieved annual sales of approximately $63.8 million.
Commenting on the launch, Marc Kikuchi, president & business head, North America said, ?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.?
Glenmark Pharmaceuticals is engaged in the business of development, manufacturing and marketing of pharmaceutical products both formulation and active pharmaceuticals ingredient to regulated and semi-regulated markets.
The company?s consolidated net profit tanked 23.4% to Rs 260.79 crore on 5.1% decline in revenue from operations to Rs 3059.33 crore in Q1 FY26 over Q1 FY25.
Shares of Glenmark Pharmaceuticals fell 1.50% to Rs 1,869.60 on the BSE.
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