Porton Pharma Solutions Ltd.

Overview

Porton Pharma Solutions Ltd. is a leading contract development and manufacturing organization (CDMO) based in China. The company provides high-quality and efficient pharmaceutical services to global pharmaceutical companies, focusing on custom synthesis and process development solutions.

Therapeutic areas

API / Drug Master Files

Porton Pharma Solutions Ltd. holds 24 active (26 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.

• RIMEGEPANT SULFATE (NON-STERILE)Active2025-06-25
• ABEMACICLIB DRUG SUBSTANCE (NON-STERILE)Active2025-05-27
• VENETOCLAXActive2025-04-10
• NIRAPARIB TOSYLATE MONOHYDRATEActive2025-03-17
• (S)-4-OXO-4,6,7,8-TETRAHYDROPYRROLO[1,2-A]PYRIMIDINE-6-CARBOXYLIC ACIDActive2025-03-16
• DOUTEGRAVIR SODIUM DRUG SUBSTANCE (MON-STERILE)Active2024-10-18
• VONOPRAZAN FUMARATEActive2024-10-14
• PHLOROGLUCINOL DIHYDRATEActive2024-09-24
• TRIMETHYLPHLOROGLUCINOL DRUG SUBSTANCE (NON-STERILE)Active2024-09-24
• SODIUM (S)-4-OXO-4,6,7,8-TETRAHYDROPYRROLO[1,2-A]PYRIMIDINE-6-CARBOXYLATEActive2024-09-13
• BALOXAVIR MARBOXILActive2024-09-05
• VIBEGRONActive2024-08-01
• RELUGOLIXActive2024-06-14
• ALECTINIB HYDROCHLORIDEActive2024-06-13
• ISAVUCONAZONIUM SULFATE API, NON-STERILE DRUG SUBSTANCEActive2023-11-10

Showing 15 of 26 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to Porton Pharma Solutions Ltd. in our records. PharmaTek screens the full directory against live FDA enforcement data.