SHANGHAI NEW HUALIAN PHARMACEUTICAL CO LTD

Overview

SHANGHAI NEW HUALIAN PHARMACEUTICAL CO LTD is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering CABOZANTINIB S-MALATE; HYDROCORTISONE; IRON SUCROSE; ROCURONIUM BROMIDE INTERMEDIATE G (NEU1017-G); TICAGRELOR.

API / Drug Master Files

SHANGHAI NEW HUALIAN PHARMACEUTICAL CO LTD 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.

• CABOZANTINIB S-MALATEActive2026-01-27
• TICAGRELORActive2023-06-26
• IRON SUCROSEActive2023-04-21
• ROCURONIUM BROMIDE INTERMEDIATE G (NEU1017-G)Active2022-02-08
• HYDROCORTISONEActive2014-07-22

FDA compliance signals

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