Pharmaceutical ingredient certificate suspensions put Russian drugmakers under pressure

Certificates suspended for Mexican and Chinese ingredients

Russia’s pharmaceutical market is facing the suspension of certificates of suitability covering active pharmaceutical ingredients supplied from Mexico and China, as well as some European components, Pravda.ru reported. The measures concern ingredients used to manufacture medicines rather than a blanket prohibition on finished tablets, creams or injectable products.

Mexican manufacturer Uquifa accounts for 10 suspended certificates issued between 2003 and 2022. According to Pravda.ru, the action followed the company’s refusal to admit inspectors from the European Directorate for the Quality of Medicines & HealthCare, or EDQM, to its production sites. Without an inspection, regulators lack the verification needed to confirm that manufacturing and quality-control requirements are being followed.

Diabetes and hormonal medicines exposed

One affected Uquifa ingredient is metformin, a core treatment for type 2 diabetes. The original medicine, Glucophage, is produced by Germany’s Merck KGaA, while 104 metformin-based medicines are registered in Russia. The suspension does not establish that all of those products use Uquifa material, but manufacturers that do depend on the Mexican supplier will have to seek replacement ingredients or change suppliers.

Chinese producer Xi'an Guokang Ruijin had four certificates suspended after failing a good manufacturing practice inspection, according to Pravda.ru. The affected substances include three forms of dexamethasone, a potent immunosuppressant used in 41 medicines registered in Russia. A certificate for betamethasone was also suspended. The ingredient is used in hormonal creams, with 61 betamethasone-based products registered in the country.

Surgical and hepatitis treatments also affected

Three certificates connected with another Chinese producer, Lianyungang Guike, were suspended. They cover atracurium besilate and cisatracurium besilate, muscle relaxants used in surgery, as well as entecavir, which is used to treat hepatitis B. The inclusion of hospital medicines makes continuity of supply relevant not only to retail pharmacies but also to manufacturers, distributors and healthcare procurement systems.

A suspended ingredient certificate does not mean that every medicine containing the substance will immediately disappear from pharmacies or that products already on sale are unsafe. Pravda.ru said factories that bought material from the affected suppliers must demonstrate the safety of their batches or move to another source. The practical impact will therefore depend on inventories, the suppliers named in individual product dossiers and the time needed to qualify alternatives.

Supplier replacement may slow production

Changing an active ingredient supplier is more complex than switching a routine industrial input. Drugmakers must ensure that replacement material meets specifications and that the relevant manufacturing and registration documentation supports its use. For generic producers relying on a limited number of approved sources, this can interrupt production even when the same active ingredient remains available elsewhere.

The latest suspensions follow earlier changes to Russia’s State Register of Medicines. Pravda.ru reported that seven substances were removed from the register in July 2026, including warfarin and alfuzosin associated with Czech producer Farmak, and metamizole sodium and latanoprost associated with France’s Euroapi.

The immediate issue is therefore supplier qualification rather than a confirmed nationwide shortage. Producers using the affected Mexican, Chinese or European ingredients must establish whether existing batches can continue to be used and how quickly alternative sources can be approved. Distributors, hospitals and pharmacy chains will be watching stock levels for metformin, dexamethasone, betamethasone, surgical muscle relaxants and entecavir while manufacturers adjust their sourcing.