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A.forall Announces ANDA Approval for Sodium Bicarbonate for Injection, USP

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WHITE BEAR LAKE, Minn.--(BUSINESS WIRE)--A.forall announced through its U.S. subsidiary, Milla Pharmaceuticals Inc., that it has received Abbreviated New Drug Application (ANDA) approval by the U.S. Food and Drug Administration (FDA) for 8.4% Sodium Bicarbonate Injection, USP 50 mEq/ 50 mL vials for intravenous use.

Sodium Bicarbonate for Injection, USP is indicated as an alkalinizing agent to correct severe metabolic acidosis. The product has intermittently appeared on the FDA Drug shortages list since 2013, with severe supply chain disruption since March 2017.

Sodium Bicarbonate for Injection, USP had US sales of approximately $68 million for the twelve months ending in May 2026*.

This marks the 10th generic product for A.forall in the US and the second injectable to correct metabolic acidosis, after adding Tromethamine to their portfolio in January 2025. Milla Pharmaceuticals, as part of A.forall, has added 4 more products (5 ANDA’s) since then and continues on a strong expansion path.

“This product was previously reported in shortage in the US for multiple years and has had so many supply chain disruptions that we are convinced the approval and launch of Sodium Bicarbonate Injection, USP is a great tool to combat metabolic acidosis. We are excited to continue expanding our offering of high-quality generic injectables supply throughout and beyond the U.S. market,” commented Erik Lazarich, A.forall’s President of U.S. Operations.

* Source: IQVIA

About A.forall & Milla Pharmaceuticals, an A.forall company

At the same time, we are reducing costs to the healthcare system and increasing customer convenience for a more sustainable world.

Milla Pharmaceuticals Inc., the U.S. subsidiary of A.forall, is engaged in the development, licensing, acquisition, and commercialization of generic prescription drugs for the US market, focusing on niche injectable and solution products for hospitals and clinics.

More info: About – A.forall & About – Milla Pharmaceuticals

Contacts

erik.lazarich@aforallpharma.com
+1 (952) 449-5154

Industry:
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Contacts

erik.lazarich@aforallpharma.com
+1 (952) 449-5154

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