X-THERMA INC

Overview

X-THERMA INC is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering CRYOPROTECTANT SOLUTIONS FOR THE CRYOPRESERVATION AND STORAGE OF CELLS, CELL PRODUCTS & THERAPIES, TISSUES, ORGANS & BIOLOGICS FOR PRODUCTION OF BIOPHARMACEUTICALS, TREATMENTS & TRANSPLANTATION.

API / Drug Master Files

X-THERMA 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.

• CRYOPROTECTANT SOLUTIONS FOR THE CRYOPRESERVATION AND STORAGE OF CELLS, CELL PRODUCTS & THERAPIES, TISSUES, ORGANS & BIOLOGICS FOR PRODUCTION OF BIOPHARMACEUTICALS, TREATMENTS & TRANSPLANTATIONActive2024-01-31

FDA compliance signals

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