Hermes Pharma, specialist in user-friendly oral dosage forms, successfully completed the good manufacturing practices (GMP) inspection of its production facilities by Russian authorities.
The German plant in Wolfratshausen, as well as the production facility in Wolfsberg, Austria, are now both authorised to manufacture medicinal products for the Russian market. The certification covers the manufacturing of several dosage forms and products.
User-friendly dosage forms such as instant drinks, orally disintegrating granules, lozenges, effervescent and chewable tablets represent a rapidly growing opportunity in the pharmaceuticals market, especially for patients who find swallowing tablets difficult.
These dosage forms are also gaining traction in Russia as companies seek to better meet the needs of patients, while diversifying their product portfolio, strengthening their brands and extending product life-cycles.
More than 7000 tons of material is processed and two billion effervescent and chewable tablets, lozenges, instant drinks and orally disintegrating granules are manufactured annually in Hermes Pharma’s production plants.
All operations, such as weighing, blending, granulating, tableting and packaging, take place in highly-automated systems. Rigorous quality assurance and control ensure compliance with GMP, regulatory demands and client specifications.
Dr Thomas Hein, Senior P Commercial and Regulatory Affairs at Hermes Pharma, said: “For a contract development and manufacturing organisation (CDMO) like Hermes Pharma, the successful inspection through the Russian authorities is extremely important.”
“It does not only reflect our long-standing commitment to producing high quality products under stringent GMP conditions. It also marks a significant milestone as we are now able to fully support our customers wishing to sell their medicinal products manufactured by us into the Russian market.”