SHANXI SHUANGYAN PHARMACEUTICAL CO LTD

Overview

SHANXI SHUANGYAN PHARMACEUTICAL CO LTD is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering AMOXICILLIN TRIHYDRATE (POWDER , COMPACTED); POTASSIUM CLAVULANATE DILUTED WITH MICROCRYSTALLINE CELLULOSE IN THE RATIO 1:1; POTASSIUM CLAVULANATE DILUTED WITH SILICON DIOXIDE IN THE RATIO 1:1.

API / Drug Master Files

SHANXI SHUANGYAN PHARMACEUTICAL CO LTD holds 3 active (3 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• AMOXICILLIN TRIHYDRATE (POWDER , COMPACTED)Active2026-03-29
• POTASSIUM CLAVULANATE DILUTED WITH MICROCRYSTALLINE CELLULOSE IN THE RATIO 1:1Active2026-02-11
• POTASSIUM CLAVULANATE DILUTED WITH SILICON DIOXIDE IN THE RATIO 1:1Active2026-02-02

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to SHANXI SHUANGYAN PHARMACEUTICAL CO LTD in our records. PharmaTek screens the full directory against live FDA enforcement data.