Company

Ajanta Pharma

2 developments in the corpus

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AUG 11, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Metformin Hydrochloride (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of labeling changes for an existing metformin hydrochloride extended-release product; no clinical trial data or efficacy evidence is reported.

Regulatory UpdateMetformin Hydrochloride Ajanta Pharma

APR 6, 2026 · REGULATORY APPROVAL

FDA approval: Dapagliflozin

U.S. Food and Drug Administration

FDA approval of a generic dapagliflozin formulation; establishes bioequivalence and manufacturing compliance, not efficacy or clinical superiority.

Regulatory UpdateDapagliflozin Ajanta Pharma

Reported

Approval status date2026-04-06

Approved strengths5 mg, 10 mg