One name, two pharmaceutical manufacturers: both the US pharmaceutical group Merck & Co. and the German pharmaceutical company Merck KGaA have their origins in Darmstadt. Strict GMP guidelines apply to the manufacture of pharmaceutical products on both sides of the Atlantic.

A Darmstadt pharmacy, the birthplace of two major pharmaceutical manufacturers: Blog post by the pharmaceutical interpreters and translators at GMP-inspection.com

In 1668, Friedrich Jakob Merck founded a pharmacy in Darmstadt, which is the common origin of the two pharmaceutical companies Merck & Co. –  one of today’s top-selling pharmaceutical manufacturers in the United States – and the German Merck KGaA. If we take as the founding date of both companies, they can be considered to be among the oldest pharmaceutical manufacturers in the world. One of the manufacturer’s descendants, Heinrich Emanuel Merck, began distributing active ingredients such as alkaloids, which he had previously isolated himself, in 1827. With his sons, he founded the pharmaceutical company E. Merck Darmstadt in 1850, which 10 years later already had 800 products on offer. Pharmaceutical production at Merck was held to strict purity standards – an early forerunner of the GMP guidelines now in force. Today, these exist as strict regulations for production conditions and quality assurance procedures at pharmaceutical companies. Compliance with them is  verified at every production site that falls under this jurisdiction during regular GMP inspections.

Merck established a branch in the USA as early as 1887, which became the joint-stock company Merck & Co. in 1908. During the First World War, the company was confiscated from the Allied Powers’ enemy Germany. After the end of the war, Georg Merck, who had acquired US citizenship, succeeded in buying the company back. Since then, both pharmaceutical manufacturers have existed as completely independent companies. One unusual fact is that both companies still have to do without the company name Merck when they sell their products in each other's home countries. In North America, the German pharmaceutical company trades under the abbreviation EMD, while Merck & Co. uses the company name MSD in non-American countries such as Germany, Switzerland and Austria.

Merck & Co: One of the world's top-selling pharmaceutical companies – facts and figures based on our pharmaceutical interpreters and GMP translators’ research

The US pharmaceutical manufacturer Merck & Co. is now one of the Big Five in the pharmaceutical industry. In 2020, the  revenue of the group, which is headquartered in the state of New Jersey, amounted to 48 billion USD. The pharmaceutical company employs around 74,000 people worldwide. One of Merck & Co's most successful pharmaceuticals is the immuno-oncology medication pembrolizumab. During the COVID-19 pandemic, the pharmaceutical company was unsuccessful at developing its own vaccine. However, emergency approval was granted in the USA for the COVID-19 medication molnupiravir. The FDA (Food and Drug Administration) is responsible for this in the United States. GMP inspections are carried out for all pharmaceutical products that are to be sold in the USA under FDA supervision. For this purpose, the authority sends several GMP inspectors to the site to be inspected and checks the entire production area and production process to ensure compliance with American GMP guidelines. Of course, this does not only apply to US companies. Pharmaceutical manufacturers from Germany, Austria and Switzerland also receive visits from GMP inspectors from the FDA when a drug produced abroad needs to be approved for the first time or re-approved in the USA. The English language skills of company employees are often inadequate for these foreign GMP inspections. To ensure flawless communication with the FDA, specialized pharmaceutical interpreters are then called in to interpret between the GMP inspectors and the on-site employees during the GMP inspection and also to provide written translations of pharmaceutical documents into English or German.

The pharmaceutical manufacturer Merck KGaA is one of Germany's top five

One of Germany’s largest pharmaceutical manufacturers, also under the Merck name, also has its roots in Darmstadt. In 2022, the company reached revenue of over 20 billion USD for the first time. More than 62,000 people are employed in a total of 66 countries. In addition to pharmaceutical production, the company also includes chemical and medical technology divisions ("Life Science" and "Electronics"). In the past decade, Merck KGaA has opened many branches in Eastern Europe. Of course, the relevant GMP guidelines of the respective country apply in each target market. For example, the Russian equivalent of the FDA mentioned above is the SID & GP authority, which also sends its Russian GMP inspectors to Germany if, for example, a medication produced by Merck in Darmstadt needs to be approved and distributed in Russia. Specialized pharmaceutical interpreters for Russian are indispensable here; they not only need to have a perfect command of German and Russian, but must also have specialist knowledge in pharmacy, medicine, technology and other fields. Only with highly qualified personnel in the field of pharmaceutical translation can a Russian GMP inspection be successfully supervised.

Pharmaceutical interpreters and translators for your GMP inspection

The international pharmaceutical world has many exciting company stories to offer, which we as translators for GMP inspections and specialized pharmaceutical interpreters prepare for you in our blog. We hope you have enjoyed reading this article. If you work in the pharmaceutical industry yourself and need support in carrying out a GMP inspection - whether by the FDA, the SID&GP or another authority – please do not hesitate to contact us. Our pharmaceutical interpreters have many years of experience in accompanying GMP inspections throughout Europe and have the necessary expertise in this highly complex field. We look forward to hearing from you!

Image: National Cancer Institute, unsplash.com