LEVENA (SUZHOU) BIOPHARMA CO LTD

Overview

LEVENA (SUZHOU) BIOPHARMA CO LTD is an active pharmaceutical ingredient (API) supplier with 13 active FDA Type II Drug Master Files, covering DUOSTATIN 5 (DUO-5); FPVC-1; LND1001 (K-lock-VSP-Cit-DUO-5); LND1001-1; LND1005 (MC-VC-PAB-MMAE); LND1016 (AS269).

API / Drug Master Files

LEVENA (SUZHOU) BIOPHARMA CO LTD holds 13 active (13 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.

• LND1001-1Active2025-05-26
• FPVC-1Active2024-08-12
• LND1058 (BCN-OH)Active2023-08-11
• DUOSTATIN 5 (DUO-5)Active2023-06-15
• LND1027 (MC-VAL-LYS(MPEG23)-PAB-MMAE)Active2023-05-26
• LND1035 (MC-VAL-CIT-PAB-DMEA-SN38)Active2023-04-28
• LND1030 (EXATECAN MESYLATE)Active2022-12-30
• MONOMETHYL AURISTATIN E (MMAE)Active2022-10-27
• LND1001 (K-lock-VSP-Cit-DUO-5)Active2022-05-07
• LND1018 (GLY2-EDA-PNU)Active2022-03-02
• LND1025 (C-lock-G5-DUO-5)Active2022-02-22
• LND1005 (MC-VC-PAB-MMAE)Active2021-12-22
• LND1016 (AS269)Active2021-04-30

FDA compliance signals

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