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Jodas Expoim filed 24 lawsuits against the Russian Ministry of Health in three months.

Jodas Expoim filed 24 lawsuits against the Russian Ministry of Health in three months.

Based on the court decisions, the cases in question include the broad-spectrum antibiotic Imipenem and Cilastatin Jodas (imipenem+[cilastatin]), the registration certificate for which was revoked at the end of May of this year; the antifungal drug Fluconazole (fluconazole), for which the Ministry of Health made a similar decision in July 2025; the antibiotic Levofloxacin-Nova (levofloxacin), the registration certificate for which was revoked in July; and the antitumor drug Palbolib (palbociclib), whose registration certificate was suspended in October 2024.

Jodas Expoim filed its first thematic lawsuits with the Moscow Arbitration Court back in August. The company filed a second set of 18 claims on October 17.

At the same time, the Moscow Region Arbitration Court considered a claim by Roszdravnadzor against the manufacturer seeking administrative liability for failure to comply with licensing requirements. In mid-September, the court upheld the claim and ordered Jodas to pay a fine of 50,000 rubles. According to the first-instance ruling, the pharmaceutical company was found to have violated Part 4 of Article 14.1 of the Code of Administrative Offenses of the Russian Federation (conducting business activities in gross violation of the requirements and conditions stipulated by a special permit): during an unscheduled on-site inspection in June 2025, the Jodas production site was found to lack designated areas for receiving and shipping medications, a container cleaning area, and a drug storage area. Furthermore, the regulator cited the storage of expired and counterfeit medications outside the designated area. The defendant's representatives admitted guilt and requested the minimum sentence.

Since the beginning of 2025, the Ministry of Health has repeatedly suspended and cancelled the registration of Jodas Expoim drugs, citing violations of good manufacturing practices and non-compliance with licensing conditions.

Among the cancelled drugs are Semaglutide J (semaglutide), a type 2 diabetes treatment that could have become the cheapest generic equivalent of the original Ozempic from the Danish company Novo Nordisk, and the first generic version of the orphan drug Evrisdi (risdiplam) in Russia, produced by the Swiss company Roche and marketed under the trade name Diplam. The former drug was excluded from the State Register of Medicines based on the results of a review of its registration dossier and the failure to take measures to prevent violations of Russian law. The registration certificate for Diplam was suspended in April 2025: an order from the Russian Ministry of Health stated that the registration certificate contained inaccurate information. The Federal Antimonopoly Service later published a decision to cancel the approval of the maximum selling price for the orphan drug.

The increased regulatory scrutiny of the company stems from the ongoing criminal investigation into Alexey Sazonov, head of the Department for Regulation of Medicines at the Russian Ministry of Health, who is accused of accepting a particularly large bribe. Jodas Expoim Director Parsad Singh Shashi Shankar is also a defendant in this case and is under investigation. Media reports indicate that the company's top manager allegedly reached an agreement with a Ministry of Health representative to retain the drug's regulatory approval certificates.

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