Russia Cancels State Registration of Semaglutide J from Indian Jodas Expoim

The Indian pharmaceutical company registered its analogue in the Russian Federation in January 2025. The drug was presented in three dosages - 1, 0.25 and 0.5 mg. At the end of March, the FAS agreed on the maximum price for Semaglutide J, which turned out to be 9% lower than for domestic generics, and 32% cheaper than the original drug.

In 2025, the Russian Ministry of Health suspended the use of at least 14 drugs for which Jodas Expoim was the holder of registration certificates. The decisions were based on information revealed about the company's non-compliance with the requirements of good manufacturing practice rules or about the violation of licensing requirements.

In February, the regulator issued six corresponding orders. The Russian Ministry of Industry and Trade then told Vademecum that Jodas Expoim “does not have valid GMP certificates,” and the last inspection of the site took place in 2023. As a result, the agency found that the drug manufacturer did not comply with the requirements of the good manufacturing practice of the Eurasian Economic Union.

In April, the Ministry of Health suspended the registration certificates of eight more drugs. Among them is the second drug in Russia after the original Evrisdi with risdiplam - Diplam. The reason for the suspension, according to the department, was the presence of inaccurate documents and data in the registration dossier.