Our blog offers much more than just information about interpreting and translating between Russian, English, and German. Here, we share our insights from GMP inspections by foreign authorities and provide valuable recommendations on how to successfully pass your GMP inspection or audit. You will also periodically receive useful information about the Russian and Belarusian pharmaceutical markets and the market of the Eurasian Economic Union (EAEU). As enthusiastic pharmaceutical interpreters and GMP translators, we are excited to share valuable information about the history of the world's largest pharmaceutical manufacturers and their secrets to success.
Bayer is Germany's best-known and largest pharmaceutical manufacturer. Other than the crisis-ridden Agriculture division, the Pharmaceuticals and Consumer Health divisions (non-prescription pharmaceuticals) record stable sales. Find out more about Bayer's company history and development.
160 years ago, on 1 August 1863 to be precise, Friedrich Bayer founded his pharmaceutical company in Barmen, which today belongs to the city of Wuppertal. The headquarters and production sites of the expanding pharmaceutical manufacturer were relocated to Elberfeld in 1878, but plans for a new move were soon underway: The site of the chemical producer Leverkus und Söhne was chosen for the new location, from which the name of the city of Leverkusen, which was only founded in 1930, is derived. To this day, Bayer and Leverkusen form an intellectual unit, not least thanks to the Bundesliga club.
In 1913, 70 years after the company was founded, Bayer already had 10,600 employees, almost 1,000 of whom worked outside Germany. The pharmaceutical manufacturer already had subsidiaries in France, the USA and Russia, among others. The First World War marked a turning point in Bayer's history: The American and Russian parts of the company were expropriated, resulting in the loss of important sales markets. In 1925, Bayer merged with seven other German chemical and pharmaceutical manufacturers to form IG Farben. During the National Socialist era, this company rose to become the largest group in Europe and at times the largest pharmaceutical manufacturer in the world, mainly through expropriations. After the end of the war, IG Farben was split up again and a new phase began for the pharmaceutical manufacturer Bayer AG. Further locations were established, for example in Uerdingen, and the company grew rapidly. In 1990, Bayer had 171,000 employees, and four years later production of Bayer's best-known pharmaceutical product, Aspirin, began at the new site in Bitterfeld.
Bayer has undergone a number of reorganisations on its way to joining the Big Five of the pharmaceutical industry. Between 2003 and 2005, for example, a large part of the chemicals and plastics production business was spun off, creating the Lanxess Group. During the same period, Bayer took over the OTC pharmaceuticals division of Swiss pharmaceutical manufacturer Roche. Today, Bayer is a three-division group: In addition to the agrochemicals segment, which has been hit by the Monsanto takeover and numerous lawsuits in the USA (Crop Science), Bayer concentrates on the Pharmaceuticals and Consumer Health business areas (OTC pharmaceuticals). The Group's total revenue in 2022 was around USD 50.7 billion, of which more than 50% was attributable to the two pharmaceutical divisions. This makes Bayer AG Germany's largest pharmaceutical manufacturer and the third-largest group in the pharmaceutical industry in Germany, Austria and Switzerland after Roche (whose former head of pharmaceuticals Bill Anderson is now at the helm at Bayer) and Novartis. The company currently employs over 100,000 people worldwide, with over 22,500 employees in Germany. Some of the best-selling products are Aspirin (Pharmaceuticals), Alka-Seltzer, Bepanthen and Iberogast (Consumer Health).
Bayer sells these and many other pharmaceutical products all over the world. In the strictly regulated pharmaceutical market, a number of hurdles have to be overcome. The competent regulatory authority decides on the approval of a medicine. In the EU, this is the European Medicines Evaluation Agency (EMEA), in the USA the FDA and in Russia the Roszdravnadzor (on whose behalf the Russian institute SID&GP carries out GMP inspections worldwide). Their respective GMP guidelines form the basis. Their compliance is checked during GMP inspections. For this purpose, a team of GMP inspectors travels to the production site in question. Once the GMP inspection has been successfully passed, the product manufactured at the site can be approved or the approval renewed. When it comes to approval abroad, specialised pharmaceutical interpreters come into play. For example, if Bayer wants to obtain approval for a drug manufactured in Germany for Russia (or in the Eurasian Economic Union), it must first apply to the Minpromtorg, to which the Russian SID&GP is subordinate, or to the relevant supervisory authority of the respective member of the EAEU for a GMP inspection. The site then hast to be inspected by Russian GMP inspectors for compliance with the GMP guidelines applicable in the EAEU. Specialised and qualified pharmaceutical interpreters and GMP translators for Russian and often English are used to ensure smooth communication between Russian GMP inspectors and employees at the German site. Written translations of pharmaceutical documents are often required in advance. If no critical or not too many major deficiencies against Russian GMP guidelines are identified during the GMP inspection, approval can usually be granted. The official procedure is as follows: 30 calendar days after the Russian GMP inspection, the inspecting authority SID&GP will issue a GMP inspection report. It will be handed over to the Russian representative of the German pharmaceutical manufacturer and to the Minpromtorg (Ministry of Industry and Trade of the Russian Federation). The Minpromtorg then decides whether or not to issue the GMP certificate required for approval.
With our series of blog articles on the largest pharmaceutical manufacturers in Europe and the world, we want to provide you with interesting facts and interconnections from the world of pharmaceutical manufacturers in an entertaining way. In doing so, we can draw on our wealth of experience. Our qualified pharmaceutical interpreters and GMP translators for Russian and English are deployed throughout Europe and have contributed to the successful completion of numerous Russian and Belarusian GMP inspections. You can find independent information about the evaluation of our services in the letters of recommendation from our pharmaceutical customers on our website. Our professional pharmaceutical interpreters and GMP translators for Russian and English and, if required, our network of partners for other languages will be happy to provide your pharmaceutical company with competent and reliable support during upcoming GMP inspections.
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