PICHEM FORSCHUNGS-UND ENTWICKLUNGS GMBH

Overview

PICHEM FORSCHUNGS-UND ENTWICKLUNGS GMBH is an active pharmaceutical ingredient (API) supplier with 14 active FDA Type II Drug Master Files, covering AB001-P1; API2568; DAZDOTUFTIDE; DOTA-MGS5; DOTA-PTR-58; EDOTREOTIDE.

API / Drug Master Files

PICHEM FORSCHUNGS-UND ENTWICKLUNGS GMBH holds 14 active (16 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.

• DOTA-PTR-58Active2025-08-13
• DOTA-MGS5Active2025-03-04
• AB001-P1Active2024-11-20
• NODAGA-PSMA-I&TActive2024-08-19
• API2568Active2023-04-21
• VIPIVOTIDE TETRAXETANActive2022-10-21
• EDOTREOTIDEActive2022-03-16
• GOZETOTIDEActive2020-11-30
• ZADAVOTIDE GURAXETANActive2020-09-11
• FAP-2286Active2020-09-08
• DAZDOTUFTIDEActive2019-08-14
• NEOBActive2017-11-23
• PSMA-R2Active2017-10-16
• OXODOTREOTIDEActive2015-04-09
• P467Inactive2021-10-15

Showing 15 of 16 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to PICHEM FORSCHUNGS-UND ENTWICKLUNGS GMBH in our records. PharmaTek screens the full directory against live FDA enforcement data.