Quality right from the start
We guarantee transparency and security
AMINO quality management starts even before the raw materials for our amino acids have reached the factory. Our quality management system takes care of appropriate acquisition, and the constant exchange with our partners and suppliers provide maximum transparency.
We react to changes in the market by a variety of strategic alliances and partnerships. We make sure that our customers have at their disposal the whole range of pharmaceutical products at any time. Through our cooperation with competent suppliers we ensure that all our raw materials always correspond to our specifications and the requirements of international standards.
Thus we ensure the best conditions for absolute reliability of our products.
Absolute purity for our amino acids
Modern production according to current GMP guidelines
In our modern multi-purpose facilities we produce various amino acids and other products of pharmaceutical quality.
The qualification of our equipment according to current GMP guidelines and the validation of the production processes secure that our customers always receive pharmaceutical products of high purity and effectiveness. The packaging of the products takes place, of course, in clean rooms.
Our expansion strategy consists in the extension of our production line and the adaptation of our facilities to the newest technical standards. The permanent and continuous improvement of all production processes is part of this strategy. For this reason, a new warehouse and new production facility have been inaugurated in July 2011. In July 2012 we started operating a new warehouse for our finished products.
Continuous check up
Interdepartmental quality control
The enduring confidence of our numerous customers worldwide has many reasons. One of them is the permanent quality control on all levels of the production of our pharmaceutical substances. Our specialists in our own laboratories use the whole range of chemical, physical and microbiological methods of analysis. A continuous check and inspections examine not only the finished products, but also intermediate products, auxiliary products and processing aids as well as packing material.
Also the actual production is subject to permanent control. Right on the spot our experts test the products and evaluate their findings. Through stability studies we examine the stability of our amino acids - under specific climatic conditions. Before we offer them on the market, our experienced experts examine and release them according to the specifications and requirements of the pharmaceutical laws.
Benefit from our experience!
We help you with administrative issues
Because of our cooperation with many customers on the international level, our experts have acquired extensive experience in the field of Regulatory Affairs. Nowadays the conditions for the admission of amino acids and other pharmaceutical products differ from country to country, from region to region, and they are complex.
We gladly help you with the documents required for the registration of your pharmaceutical products, the correct interpretation of information in questionnaires and the provision of all necessary documents. AMINO possesses Drug Master Files and CEP certificates.
You can always be sure that AMINO fulfils the rules and requirements of the respective administration. We are subject to the supervision of the health and safety control office in Braunschweig, Germany and have the manufacturing permission according to the German Drug Act as well as a GMP Certificate. AMINO has also successfully undergone the strict control of the US American Food and Drug Administration.