Company

Alembic

2 developments in the corpus

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JUL 17, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Celecoxib (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling of celecoxib; this is a regulatory action record, not a clinical study, and does not report efficacy or safety trial outcomes.

Regulatory UpdateCelecoxib Alembic

MAR 26, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Paroxetine (Manufacturing (CMC))

U.S. Food and Drug Administration

FDA supplemental approval of manufacturing changes for paroxetine extended-release tablets; regulatory action with no clinical trial data reported.

Regulatory UpdateAlembic Paroxetine

Reported

Approval status date2026-03-26

Product strengths approved12.5 mg, 25 mg, 37.5 mg