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 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.

  • WAYNEL VPROTM HEK293 CELL LINEActive2023-04-21
  • 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.

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