U.S. Food and Drug Administration issues Complete Response Letter for Ulipristal Acetate New Drug Application

About
About Us

Headquartered in Hungary and founded in 1901, Gedeon Richter Plc. is an innovation- driven specialty pharmaceutical company. The activities of the Hungarian-directed multinational company are vertically integrated and involve pharmaceutical manufacturing, research and development, sales and marketing.
Specialty pharma transformation

The strategic goal of Gedeon Richter is to become a prominent player in the league of European-based midpharma.
Areas of Expertise
Areas of Expertise

Gedeon Richter aims to offer high added value products with a strategy firmly grounded in original research, women's healthcare and biosimilars.
At the forefront of innovation

The research of new chemical entities has always been of paramount importance to Richter’s corporate strategy. Richter’s R&D base, which employs more than 1,200 people, makes the company the most important pharmaceutical research centre in Central Eastern Europe.
Our Products
Our Products

Richter manufactures more than 200 drugs including original, generic and licensed products which provide effective, modern and reasonably priced treatments in almost every therapeutic area. The company focuses on developing and manufacturing central nervous system, cardiovascular and gynaecological products.
Wide range of therapies for women

With in-house active ingredient manufacturing and a comprehensive product portfolio, Richter offers an innovative therapeutic solution for every age group and condition.
Sustainability
Sustainability

Long-term thinking and continuous innovation are stable building blocks of Gedeon Richter’s history. We believe that we should meet the needs of the present in such a way that future generations can turn to us with confidence.
Strong corporate culture

Our human resources form the basis on which our continuous business success and organic growth can be built. We are proud that the Richter name stands not only for innovative products, but also a stable and friendly workplace.

Gedeon Richter Investors Announcements U.S. Food and Drug Administration issues Complete Response Letter for Ulipristal Acetate New Drug Application

22/08/2018

Business related Regulatory Marketing authorization application postponed Women's Healthcare PARTNER - ALLERGAN / ABBVIE / ACTAVIS API - ULIPRISTAL ACETATE

20180822_EN_BUS_WHC_REG_MAA_P_ALLERGAN_ULIPRISTAL ACETATE

21 kb 22/08/2018 pdf

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