Germany pharmaceutical industry

Aniline is a purple dye that has the distinction of being the first synthetic dye ever made. It was developed in Germany at the end of the 19th century and its manufacture led to the development of the entire synthetic chemical and pharmaceutical industry that we know today. It is used as a dye and also as a stage in the synthesis of other dyes and chemicals. Unfortunately, both aniline and its derivatives, such as monomethyl-analine and dimethylaniline, are toxic. 

Fully automated workstations can automatically fill vessels with dissolution medium, drop the tablets or capsules, collect multiple samples, and clean vessels. Zymark MultiDose Automated Dissolution Workstation (Zymark Corporation, Hopkinton, MA), Sotax AT70 Smart (Sotax Corporation, Horsham, PA), and AUTO DISS systems (Pharma Test GmbH, Hainburg, Germany) are several popular automated systems used within the pharmaceutical industry. 

Applicants are free to solicit advice from individual Member States and according to various surveys conducted by the European Federation of Pharmaceutical Industries and Associations, they often do. Apart from the FDA, these surveys reveal, the EU Member States most often consulted are Germany, France, Sweden and the United Kingdom. Flowever, it is often important to secure a pan-European advice. Article 51 of Council Regulation EEC/2309/93 requires the EMEA to provide the Member States and the institutions of the Commimity with the best possible scientific advice on any question relating to the evaluation of the quality, the safety and the efficacy of medicinal products for human... 

Bernstein, J. Polymorphism and Patents from a Chemist s Point of View. In Hilfiker, R. (Ed.), Polymorphism In the Pharmaceutical Industry. Weinheim, Germany Wiley-VCH, 2006, Chapter 14. 

J. Liebenau, Ethical Business, the formation of the pharmaceutical industry in Britain, Germany and the United States before 1914 , Bus. Hist., 1988, 30, 116-129. 

Similar approaches were adopted by major regulatory authorities in other countries, including the United Kingdom, France, Germany, Italy, and Scandinavia and subsequently the European Union. The official agencies and the pharmaceutical industries own experts have published recommendations for a wide range of types of toxicity tests to provide comprehensive data in stardardized form for assessment. 

Btihler, V. (2003, Sept.), Kollidon. Polyvinylpyrrolidone for the Pharmaceutical Industry, 7th ed., BASF Pharma Ingredients, Ludwigshafen, Germany. 

Because the confirmatory study also represents "worst-case" conditions, there should be few chances that an unstable product is not discovered. Examples of sources currently used by the pharmaceutical industry are xenon- and metal halide lamps (Option 1), artificial- and full spectrum daylight fluorescent tubes (Option 1), white fluorescent- and near UV-fluorescent tubes (Option 2). In (Northern) Europe (e.g., Scandinavia, England, and Germany), it seems that Option 1 with the xenon lamp is the preferred source. 

The pharmaceutical industry relies on patent laws to maximize its income from a new product (see above). However, patents were a late addition to pharmaceutical industry regulations, with many European countries only permitting patent protection after their industries had reached a degree of development - France in 1960, Germany in 1968, Japan in 1976, Switzerland in 1977 and Italy and Sweden in 1978 (Oxfam Briefing Paper, 2001). 

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