JIANGSU ALPHA PHARMACEUTICAL CO LTD SITE-II

Overview

JIANGSU ALPHA PHARMACEUTICAL CO LTD SITE-II is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering ACETOXY DAPAGLIFLOZIN; ACETOXY EMPAGLIFLOZIN; ATORVASTATIN CALCIUM TRIHYDRATE; EMPAGLIFLOZIN INTERMEDIATE (EG4); ROSUVASTATIN CALCIUM INTERMEDIATE (R1).

API / Drug Master Files

JIANGSU ALPHA PHARMACEUTICAL CO LTD SITE-II holds 5 active (5 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.

• EMPAGLIFLOZIN INTERMEDIATE (EG4)Active2025-08-20
• ROSUVASTATIN CALCIUM INTERMEDIATE (R1)Active2025-03-25
• ACETOXY DAPAGLIFLOZINActive2025-01-16
• ACETOXY EMPAGLIFLOZINActive2024-07-01
• ATORVASTATIN CALCIUM TRIHYDRATEActive2024-01-26

FDA compliance signals

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