Are you in search of a reliable European partner for active pharmaceutical ingredients (APIs) with focus on narcotics and niche products? Please meet us at the DCAT, San Carlos Hotel, 150 East, 50th St. 10022 New York, Suite 1605. Arevipharma produces APIs according to specific requirements, for example purity and particle size distribution, for customers worldwide. The production site in Radebeul, Germany was founded in 1874 by von Heyden for production of salicylic acid – the first industrial produced API. In our state-of-the-art facilities, production is performed from labscale to multitons for a variety of regular (about 75%) and narcotic APIs (about 25%). In addition Arevipharma offers Custom Manufacturing of APIs and Advanced Intermediates.
Arevipharma – More than 140 year’s experience in custom made Active Pharmaceutical Ingredients
To ensure product quality at a high level, Arevipharma focusses on professional process development in combination with an effective quality management. Our quality management system is compliant with the current requirements of the German Drug Law (AMG) and its Pharmaceuticals and Active Agent Manufacturing Ordinance (AMWHV) as well as the international regulations of Good Manufacturing Practice (GMP) according to ICH Q7 and the implementation of these regulations in the EU member states (EU GMP guide part II) and in the Unites States of America (21 CFR 210 & 211). This is the guarantee, that the products meet the highest quality standards. New methods of analysis are developed, validated and transferred by Arevipharma’s quality control. We are regularly inspected by global authorities and holder of more than 150 global DMF approvals. We also provide regulatory support for the registration of API’s. Arevipharma offers four state-of-the-art plants, including a GMP Laboratory. The total reactor volume is >150 m3 and different scales can be realized. Regarding our GMP Laboratory, dedicated equipment according to customer needs is used. For amounts < 100 kg the Small Scale Plant containing 3 reactors á 100 l is available. Larger amounts <1000 kg or even >1000 kg can be handled in Arevipharma’s Pilot Plant (7 reactors, 250-630 l) or Multi-Purpose Plant (36 reactors, 1,6 – 6,3 m3). For high potent APIs up to OEL class 4 our High Potent Plant is available.
A variety of technologies, e.g. alkylation, Friedel-Crafts reaction, Handling of corrosive and toxic compounds (POCl3, SOCl2, HBr) or hydrogenation with H2-gas with catalysts such as Pd/C or RA-Nickel or Reduction with NaBH4, LiAlH4, is offered. Milling, Micronizing and Sieving can be conducted at individual specifications. Products are stored at a 2000 m2 storing area directly on site. With its process development, Arevipharma can support customers in upscaling, process optimization and trouble shooting, as well as development of analytical methods, validation or synthesis of impurities and reference standards. Arevipharma meets all health, safety and environmental standards.
You are more than welcome to meet us and visit our facilities in Radebeul, Germany.
