
Will there be a shortage of excipients for the production of drugs?
A drug is a complex multicomponent system that consists not only of the active substance (active pharmaceutical ingredient, API) responsible for the effect of the drug, but also of excipients that perform various secondary functions. They are no less important, because thanks to them, for example, a sufficient tablet size, the necessary taste of the syrup, and the optimal consistency of the ointment are ensured. However, in the near future there may be some interruptions in the supply of such invisible but important substances.
The German concern BASF, the British Croda, and the Dutch distributor of raw materials IMCD have officially announced the termination or suspension of work in Russia.
BASF (Badische Anilin- und Soda-Fabrik - "Baden Aniline and Soda Plant" is the world's largest chemical concern. The company's headquarters is in Germany. The company develops various excipients for the pharmaceutical industry, including, for example, solutions for instant and modified release (modified release helps the drug maintain the desired concentration for a long time, thereby reducing the amount of drug taken per day). In addition, BASF supplied 10 types of pharmaceutical substances to Russia.
Croda is a British company founded in 1925 and engaged in the production of various chemicals, including those which are required for the pharmaceutical industry (surfactants, fragrances and flavors, etc.).
IMCD is the largest Dutch distributor and supplier of ingredients for the pharmaceutical and cosmetic industries. The share of its deliveries for some Russian factories was up to 30% of the total number of purchased items.
The refusal of large European companies to supply excipients and raw materials for the production of medicines will certainly have an impact on the production processes in the pharmaceutical industry. However, the positions that have left the market can be replaced by products from China and India. It won’t lose in quality but will be more expensive due to the growth in logistics costs and price increased by Chinese sellers.
But pharmaceutical companies still have to resolve regulatory issues, since the replacement of excipients, raw materials, materials and substances will require changes to the registration dossier of the drug.
References:
- https://pharmvestnik.ru/content/news/Farmproizvoditeli-soobshili-o-deficite-vspomogatelnyh-veshestv-dlya-lekarstv.html
- https://pharmaceutical.basf.com/global/en/apis-raw-materials/portfolio/building-blocks.html
- https://www.vedomosti.ru/business/articles/2022/05/11/921620-inostrannie-farmdistributori-prekraschayut