Zakłady Farmaceutyczne Polpharma S.A.

Overview

Polpharma SA is a leading Polish pharmaceutical company focusing on the production and distribution of high-quality generic drugs and active pharmaceutical ingredients. The company serves various therapeutic areas with a strong presence in Central and Eastern Europe as well as Central Asia.

Therapeutic areas

API / Drug Master Files

Zakłady Farmaceutyczne Polpharma S.A. holds 43 active (59 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.

• VISMODEGIBActive2026-01-11
• ABEMACICLIBActive2025-12-05
• BARICITINIBActive2024-12-16
• TRAMETINIB DIMETHYL SULFOXIDEActive2024-06-19
• ENZALUTAMIDEActive2024-04-04
• PALBOCICLIBActive2024-04-04
• ISAVUCONAZONIUM SULFATEActive2023-10-04
• SITAGLIPTIN HYDROCHLORIDE MONOHYDRATEActive2021-07-19
• OXCARBAZEPINEActive2019-12-20
• SAFINAMIDE METHANESULFONATEActive2019-09-30
• DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATEActive2018-12-30
• PIMAVANSERIN TARTRATEActive2018-12-08
• ARIPIPRAZOLE MONOHYDRATEActive2018-10-30
• EMPAGLIFLOZINActive2018-09-27
• ARIPIPRAZOLE LAUROXILActive2018-08-16

Showing 15 of 59 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to Zakłady Farmaceutyczne Polpharma S.A. in our records. PharmaTek screens the full directory against live FDA enforcement data.