Hoffmann-La Roche Inc.

Overview

Hoffmann-La Roche Inc., commonly referred to as Roche, is a global leader in pharmaceuticals and diagnostics and is a subsidiary of the Roche Group, headquartered in Basel, Switzerland. The company specializes in innovative medicines in oncology, immunology, infectious diseases, ophthalmology, and diseases of the central nervous system.

Therapeutic areas

Active pharmaceutical ingredients supplied

Substances Hoffmann-La Roche Inc. is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

API / Drug Master Files

Hoffmann-La Roche Inc. holds 0 active (29 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.

• INTERLEUKIN-2 (HUMAN, RECOMBINANT, E. COLI, HOFFMAN-LA ROCHE)Inactive2006-06-19
• NITOMAN (TETRABENAZINE) TABLETSInactive1993-09-24
• FLUCYTOSINE CAPSULES AND MATCHING PLACEBOInactive1991-07-25
• HIVID DIDEOXYCYTIDINE SYRUPInactive1990-07-11
• TRETINOIN CAPSULESInactive1990-06-08
• PYRIDOSTIGMINE BROMIDEInactive1987-04-20
• NEOSTIGMINE METHYLSULFATEInactive1987-04-20
• RIBOFLAVIN 5'-PHOSPHATE SODIUMInactive1986-09-08
• HUMAN GROWTH HORMONE RELEASING FACTOR-(1-44)-AMIDEInactive1984-12-21
• PROTIRELIN (THYROTROPIN RELEASING HORMONE)Inactive1984-01-09
• RO 5-9963 (DESMETHYLMISON IDAZOLEInactive1981-06-24
• Ro 21-5535 (CALCITRIOL) AMPULS 2.5 mcg/0.5mlInactive1981-03-25
• LEVORPHANOL TARTRATE AMPULES, 5ML,0.25MG/ML MNFG.IN NEW JERSEY FACIL.Inactive1980-02-15
• RO 20 5933Inactive1980-02-06
• DOXYLAMINE SUCCINATEInactive1979-11-29

Showing 15 of 29 Drug Master Files.

FDA compliance signals

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