QUACELL BIOTECHNOLOGY CO LTD

Overview

QUACELL BIOTECHNOLOGY CO LTD is an active pharmaceutical ingredient (API) supplier with 11 active FDA Type II Drug Master Files, covering 293 CELL SERUM-FREE MEDIUM HE01; CHO-K1Q CELL; F8 CELL CRYO-PRESERVATION MEDIUM; HUMAN MESENCHYMAL STEM CELL; MESENCHYMAL STEM CELL SUPPLEMENT A; OPTIVITRO SERUM-FREE CRYOPRESERVATION MEDIUM.

API / Drug Master Files

QUACELL BIOTECHNOLOGY CO LTD holds 11 active (11 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.

• MESENCHYMAL STEM CELL SUPPLEMENT AActive2025-01-20
• F8 CELL CRYO-PRESERVATION MEDIUMActive2025-01-20
• HUMAN MESENCHYMAL STEM CELLActive2025-01-06
• OPTIVITRO SERUM-FREE CRYOPRESERVATION MEDIUMActive2024-11-28
• T CELL SERUM-FREE MEDIUM TE06 (PHENOL RED-FREE)Active2023-11-24
• 293 CELL SERUM-FREE MEDIUM HE01Active2023-09-22
• T CELL SERUM-FREE MEDIUM TE000-N032Active2023-09-14
• WAYNEL VPROTM HEK293 CELL LINEActive2023-04-21
• T CELL SERUM FREE MEDIUM (PHENOL RED-FREE)Active2023-01-18
• QUACELL MEDIUM AND FEED POWDERActive2022-04-08
• CHO-K1Q CELLActive2021-09-21

FDA compliance signals

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