PTC Therapeutics, Inc.

Overview

PTC Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development, and commercialization of medicines for patients with rare disorders. The company specializes in gene therapy and small molecule drugs to treat neuromuscular and metabolic disorders.

Therapeutic areas

API / Drug Master Files

PTC Therapeutics, Inc. holds 3 active (15 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.

• ALBUTEROL SULFATE PRESSURISED INHALATION AEROSOL AND MATCHING PLACEBOActive2017-10-06
• CARFILZOMIB DRUG SUBSTANCEActive2016-02-26
• PEMETREXED DISODIUM 2.5 HYDRATE DRUG SUBSTANCEActive2013-12-06
• ENCEQUIDAR METHANESULFONATE MONOHYDRATE DRUG SUBSTANCEInactive2020-03-12
• PACLITAXEL USP (SEMI-SYNTHETIC)Inactive2014-01-09
• CABAZITAXEL ETHYL ACETATE SOLVATE DRUG SUBSTANCEInactive2013-07-18
• CABAZITAXEL MONOHYDRATE DRUG SUBSTANCEInactive2012-02-07
• BORTEZOMIB DRUG SUBSTANCEInactive2012-01-26
• DOXERCALCIFEROL DRUG SUBSTANCEInactive2009-03-05
• DOCETAXEL TRIHYDRATE DRUG SUBSTANCEInactive2007-11-15
• DOCETAXEL ANHYDROUS, NON-STERILE BULK DRUG SUBSTANCEInactive2007-10-22
• OXALIPLATIN, NON-STERILE BULK DRUG SUBSTANCEInactive2007-09-27
• IRINOTECAN HYDROCHLORIDE TRIHYDRATEInactive2007-01-26
• IRINOTECAN HYDROCHLORIDE TRIHYDRATE (NON-STERILE BULK) DRUG SUBSTANCEInactive2005-10-30
• PACLITAXEL DRUG SUBSTANCEInactive2005-05-23

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to PTC Therapeutics, Inc. in our records. PharmaTek screens the full directory against live FDA enforcement data.