Overview

LEADGENE BIOMEDICAL INC is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering RECOMBINANT PROTEIN (LGX-23001; LDG002/003PHE-GMP; LDG009PHE-GMP; LDG013/014PHE-GMP).

API / Drug Master Files

LEADGENE BIOMEDICAL INC holds 1 active (1 total) FDA Type II Drug Master File — 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.

  • RECOMBINANT PROTEIN (LGX-23001; LDG002/003PHE-GMP; LDG009PHE-GMP; LDG013/014PHE-GMP)Active2024-10-06

FDA compliance signals

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

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