ACROBIOSYSTEMS CO LTD

Overview

ACROBIOSYSTEMS CO LTD is an active pharmaceutical ingredient (API) supplier with 12 active FDA Type II Drug Master Files, covering CYTOPAK™ GMP HUMAN IL-2 PROTEIN (GMP-L02H14GB01); GMP GRADE CELL CULTURE MEDIUM (GMP-CM3101/GMP-CM3101-1/GMP-CM3102); GMP GRADE ENZYME (GMP-NUES19/ GMP-CA9S18/ GMP-NUES13); GMP GRADE IL2 PROTEIN (GMP-L02H14); GMP GRADE IL2 PROTEIN (LIQUID) (GMP-L02H14F002); LAMININ PROTEINS (LA8-H5283 LA5-H5261 & GMP-LA5H24).

API / Drug Master Files

ACROBIOSYSTEMS CO LTD holds 12 active (12 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.

• CYTOPAK™ GMP HUMAN IL-2 PROTEIN (GMP-L02H14GB01)Active2025-03-31
• STEM CELL CULTURE PROTEINS (GMP-FLLH28/GMP-SCFH25/GMP-THNH25/GMP-FGCH17/GMP-L03H18/GMP-ACAH37)Active2025-01-24
• GMP GRADE IL2 PROTEIN (LIQUID) (GMP-L02H14F002)Active2024-12-18
• GMP GRADE IL2 PROTEIN (GMP-L02H14)Active2024-10-24
• GMP GRADE ENZYME (GMP-NUES19/ GMP-CA9S18/ GMP-NUES13)Active2024-09-06
• GMP GRADE CELL CULTURE MEDIUM (GMP-CM3101/GMP-CM3101-1/GMP-CM3102)Active2024-08-22
• MAGNETIC BEADS (GMP-MBS001)Active2024-06-03
• RECOMBINANT PROTEINS (GMP-DL4H23 AND GMP-DL4H28)Active2024-01-26
• LAMININ PROTEINS (LA8-H5283 LA5-H5261 & GMP-LA5H24)Active2023-12-12
• PG GRADE MAGNETIC BEADS (MBS-C001/ MBS-C002/ MBS-C003/ MBS-C004/ MBS-C006/ MBS-C007/ MBS-C008/ MBS-C009/ MBS-C012/ MBS-C013/ MBS-C014/ MBS-C018)Active2022-09-30
• RECOMBIANT PROTEINS(GMP-L15H13/ GMP-L07H24/ GMP-L21H25/ GMP-MC0323/ GMP-MC2824/ GMP-NUES19/ GMP-CA9S19/ GMP-L02H26)Active2022-07-15
• RECOMBINANT PROTEIN (CD9-H52H2; CD9-H5251; CD9-HF2H2; CD9-HF251; CD9-H8259; BCA-H522y; BC7-H5254; BCA-HF2H1; BCA-HF254; BCA-H82E4; BC7-H82F0; RO1-H5250; CD9-HP2H3; BCA-HP2H2; FM3-Y45; FM3-Y45A1; FM3-Y45P1; FM3-FY45; FM3-BY45; FM3-BY54; FM3-HPY53; SPD-M180; BEE-N3116; PH0-H5225; CD2-H52H8; CD9-H82E9; MSN-HP2H5; LE3-H5228; CD4-HF255; CD4-H5259; EGI-HF2H7; EGR-HF2H5; MSN-H82E9)Active2020-07-06

FDA compliance signals

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