ORANO MED THERANOSTICS SAS

Overview

ORANO MED THERANOSTICS SAS is an active pharmaceutical ingredient (API) supplier with 6 active FDA Type II Drug Master Files, covering [203PB]PB-DOTAM DRUG PRODUCT; [203PB]PB-DOTAM-MAM279; [212PB]PB--DOTAM-MAM279 DRUG PRODUCT; [212PB]PB-DOTAM; 212Pb RADIOLABEL DRUG SUBSTANCE; 212Pb-DOTAMTATE DRUG PRODUCT.

API / Drug Master Files

ORANO MED THERANOSTICS SAS holds 6 active (6 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.

• [203PB]PB-DOTAM DRUG PRODUCTActive2025-11-05
• [212PB]PB-DOTAMActive2025-11-05
• [212PB]PB--DOTAM-MAM279 DRUG PRODUCTActive2025-10-07
• [203PB]PB-DOTAM-MAM279Active2025-10-07
• 212Pb-DOTAMTATE DRUG PRODUCTActive2021-05-20
• 212Pb RADIOLABEL DRUG SUBSTANCEActive2017-09-20

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to ORANO MED THERANOSTICS SAS in our records. PharmaTek screens the full directory against live FDA enforcement data.