GIRINDUS AG

GIRINDUS AG

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Company Overview
Girindus AG is an international public company engaged in the research, development, manufacture and sale of pharmaceutical products and chemical intermediate products in Germany. The company was founded as an independent service provider to the pharmaceutical industry in 1975. The company was incorporated in the year 1978, and its registered head office is located in Bernberg, Germany. The company was acquired by Solvay Organics in 2005.
Girindus is a technology-driven company offering the pharmaceutical and cosmetic industries comprehensive skills in R&D processes, cGMP-compliant scale-up and in the manufacture of active ingredients, as well as regulatory support.
Girindus delivers a fully integrated way of moving a drug candidate from lead identification through clinical trials up to commercial API production. Its equipment allows almost any quantity to be produced, from grams to multi-tons. For medchem, preclinical, clinical and radiosynthesis needs, Girindus operates laboratories and pilot plant facilities in the United States. The biotechnological and chemical scale-up and production center is located in Kuensebeck, Germany. The production center manufactures quantities required for clinical phases I/II and III, as well as commercial quantities. The company also has operations in Europe.
Business Summary
The Company offers chemical and biotechnological synthesis of APIs and precursors from laboratory scale, through pilot scale right up to large-scale production according to cGMP (current Good Manufacturing Practice).
Description and history
The Company offers chemical and biotechnological synthesis of APIs and precursors from laboratory scale, through pilot scale right up to large-scale production according to cGMP (current Good Manufacturing Practice).
The Company uses its process development, scale-up, production and regulatory affairs competencies to offer its partners a One-Stop-Shop solution for all phases between drug discovery and market launch. This one stop shop solution provides fast and flexible support for all clinical phases.
The Company also supports its customers in the approval process for their drugs and prepares on request a Drug Master File comprising all necessary information for registering a drug.
All services are performed in accordance with the strictest cGMP pharmaceutical quality requirements. This has already been confirmed several times by the FDA (Food and Drug Administration), the US health authority, for different APIs.

Founded as independent service provider to the pharmaceutical industry

Description in German
Girindus bietet die chemische und biotechnologische Synthese von APIs und Vorstufen vom Labormassstab ueber den Pilotmassstab bis hin zur grosstechnischen Produktion unter cGMP (current Good Manufacturing Practice).
Durch die Kernkompetenzen Verfahrensentwicklung, Scale-up, Produktion und regulatorische Angelegenheiten bietet Girindus seinen Partnern eine One-Stop-Shop Loesung fuer alle Phasen zwischen Wirkstoffentwicklung und Markteinfuehrung. Durch diese Loesung aus einer Hand wird eine optimale Begleitung der klinischen Phasen gewaehrleistet ? reibungslos, schnell und flexibel. Weiter begleitet Girindus seinen Kunden auf dem Weg zur Zulassung des jeweiligen Arzneimittels und erstellt auf Wunsch ein sogenanntes Drug Master File, das alle notwendigen Angaben zur Registrierung des Arzneimittels beinhaltet.
Alle Leistungen werden gemaess den hoechsten Pharma-Qualitaetsanforderungen cGMP ausgefuehrt. Dies wurde bereits mehrfach von der US-Gesundheitsbehoerde FDA fuer verschieden Wirkstoffe bestaetigt.
Business Line
Engaged in the research, development, manufacture and sale of pharmaceutical products and chemical intermediate products in Germany
Subsidiary
GIRINDUS AMERICA INC.
Advisor
DELOITTE & TOUCHE GMBH WIRTSCHAFTSPRUEFUNGSGESELLSCHAFT
IPO date
5/16/2000
US SIC Code
2834
Company Address
Buchenallee 20

City province or state postal code
51427, BERGISCH GLADBACH
Phone: +49 2204 926 90
Fax: +49 2204 926 990
Country address: GERMANY
Website url: www.girindus.com