Gedeon Richter

Overview

Gedeon Richter is a leading pharmaceutical company based in Hungary that focuses on developing, manufacturing, and marketing a wide range of innovative products. The company is renowned for its specialties in women's health and central nervous system therapies.

Therapeutic areas

API / Drug Master Files

Gedeon Richter holds 15 active (63 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.

• ESTETROL MONOHYDRATEActive2022-06-10
• NORGESTREL USPActive2020-12-16
• CARIPRAZINE HYDROCHLORIDEActive2012-07-26
• NORGESTIMATE USPActive2006-05-15
• DROSPIRENONE USPActive2004-12-03
• TERBINAFINE HYDROCHLORIDE USPActive2003-03-26
• NORELGESTROMIN USPActive2003-02-03
• AZELASTINE HCL USPActive2001-03-29
• SPIRONOLACTONE USPActive1999-03-29
• DESOGESTRELActive1997-02-18
• ETONOGESTRELActive1996-06-10
• FAMOTIDINE, USPActive1995-06-05
• NORGESTREL USPActive1991-05-20
• LEVONORGESTREL, USPActive1990-10-30
• ESTRADIOL USPActive1981-01-21

Showing 15 of 63 Drug Master Files.

FDA compliance signals

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