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@pharmprom
GMP Registry Update: 7 New Certificates and 2 Refusals in Late April 2026
The Ministry of Industry and Trade of the Russian Federation has added new data to the “Information on Issued, Withdrawn Certificates of Compliance of Manufacturers of Medicinal Products for Medical Use with the Requirements of Good Manufacturing Practice of the Eurasian Economic Union and Certificates Suspended or Terminated.” Between April 20 and 22, 2026, the regulator issued 7 certificates to…
Review of scheduled, unscheduled, and foreign GMP inspections of pharmaceutical production facilities (June 2026)
This analytical review is based on official data obtained from the Register of GMP inspection results published by the Russian Ministry of Industry and Trade (as of June 19, 2026). The analysis covers three key data sets: scheduled inspections of Russian enterprises (PPS), unscheduled inspections of Russian enterprises (VPS), and foreign inspections. 1. Scheduled inspections of Russian…
Experts continue to discuss possible changes to the regulations governing veterinary drugs in the EAEU
On June 23, a working meeting of experts was held at the Russian Union of Industrialists and Entrepreneurs (RSPP) to discuss the following issues: transitional provisions of the Decision of the Council of the Eurasian Economic Commission of January 21, 2022 “On the Rules for regulating the circulation of veterinary medicinal products in the customs territory of the Eurasian Economic Union”…
Dmitry Kudlay: Russian Technologies Break Into the Global Stage But Stall in Public Procurement
Russian pharmaceutical science has reached a level where innovative drugs generate genuine interest in the West, yet advanced developments continue to face serious regulatory barriers domestically. Dmitry Kudlay, Vice President of GENERIUM JSC and Corresponding Member of the Russian Academy of Sciences, stated this at the industry round table “Innovations in Russian Pharma: Breakthrough or…
PSK Pharma Challenges Pfizer's Rheumatoid Arthritis Drug Patent in Court
Russian pharmaceutical company PSK Pharma has filed a lawsuit against the American corporation Pfizer in the Intellectual Property Court (IPC). As reported by Gazeta.Ru, the plaintiff is demanding a review of Rospatent’s decision regarding the rights to a drug used for the treatment of moderate to severe active rheumatoid arthritis. The Core of the Claim: The Tofacitinib Dispute The judicial…
ST-1 Certificate Outweighs Active Substance: Court Forbids State Buyers from Reevaluating Drug Origin
The Arbitration Court of Moscow has issued a precedent-setting ruling protecting Russian pharmaceutical manufacturers from excessive requirements in public procurement. As reported by the GKGZ portal, the court ruled that contracting authorities have no right to independently assess a drug’s “depth of localization” and analyze the origin of the pharmaceutical substance if the bidder has provided…
TSU Scientists Synthesize Pharmaceutical Raw Materials from Capron Production By-products
As part of the development of waste-free production and green chemistry principles, researchers at Togliatti State University (TSU) have developed and patented a technology for synthesizing materials for the pharmaceutical industry. As reported on the TSU website, chemists have successfully obtained new raw materials from capron production by-products. Raw Material Base: The Industrial Waste…
Minpromtorg to Compensate Pharma Companies for Clinical Trial Costs Starting in 2027
The Ministry of Industry and Trade of the Russian Federation has announced the launch of a new support measure for the Russian biopharmaceutical industry. According to TASS, the agency plans to create a program to subsidize manufacturers’ expenses for conducting Phase III clinical trials. Launch Timeline and Selection Mechanism The draft of the corresponding regulatory act is currently in the…
Real-World Clinical Trial of Josamycin-Based Antibiotic Launched in Russia
The Russian biopharmaceutical company Promomed has announced the start of a medical study for its new antibiotic Vilpramycin SAR® (active ingredient: josamycin). As reported by the company’s press service, the main objective of the project is to evaluate the efficacy and safety profile of the drug in routine clinical practice. Full-Cycle Localized Production The market launch of Vilpramycin SAR®,…
Big Pharma 2025: Biggest Winners, New Leaders, and Major Drops in the Top 20 Rankings
The worldwide pharmaceutical industry has summarized its financial results for 2025. As reported by FiercePharma, despite patent cliffs, pricing pressures, and geopolitical instability, 16 of the 20 largest Big Pharma companies worldwide demonstrated revenue growth. The main sensation of the year was the unprecedented surge by the American corporation Eli Lilly, which, thanks to its weight-loss…
State Duma Finally Approves Law on Mobile Pharmacies
The State Duma of the Russian Federation has adopted amendments to the Law “On the Circulation of Medicines” in its second and third readings, launching an experiment in retail sales through mobile pharmacy units. According to the State Duma press service, the initiative was prepared by deputies to fulfill the Russian President’s directive and aims to radically improve the accessibility of…
Russia Simplifies Market Entry for New Veterinary Vaccines: Notification Procedure Established
The Government of the Russian Federation has decided to significantly reduce administrative barriers for the market launch of new Russian-made immunobiological products intended for veterinary use. The relevant Decree No. 417, dated April 15, 2026, signed by Mikhail Mishustin, has officially entered into force. Permit Abolition: 5 Days to Notify Rosselkhoznadzor The new document amends Government…
Kazakh Company Navipharm to Invest 2 Billion Rubles in New Pharma Plant in Dubna SEZ
In the Moscow Region, on the territory of the “Dubna” Special Economic Zone (SEZ), a large-scale project for the production of new pharmaceutical products is being launched. The investor is the Kazakh company Navipharm, which plans to invest 2 billion rubles in the creation of a high-tech manufacturing facility. The implementation of this investment project will create 200 new jobs in the…
Tomsk ECTC to Supply Russian Pharma with Critical Vaccine Raw Material
The Engineering Chemical Technology Center (ECTC) has officially received its first state registration certificate for a product of its own manufacture — beta-propiolactone (BPL). This reagent is a critical component for the Russian pharmaceutical industry, enabling the production of inactivated vaccines. The issued document confirms the substance’s compliance with safety standards and permits…
Strategic Alliance Between Novo Nordisk and OpenAI: AI to Accelerate Drug Development
Danish pharmaceutical giant Novo Nordisk has officially announced a strategic partnership with OpenAI, the developer of ChatGPT. This extensive collaboration is designed to place the company at the forefront of AI transformation and radically accelerate the time-to-market for new treatments. As the corporation’s press service reports, the move marks a new era in healthcare. A New Era of Drug…
Cardiology Breakthrough: Russian Scientists Create a Prolonged Alternative to Nitroglycerin
Researchers from Russia have presented an innovative development that could radically change the approach to treating severe cardiovascular diseases. Specialists have created a unique iron complex capable of gradually and safely releasing nitric oxide in the body over several days. As the Russian Science Foundation (RSF) reports, this discovery could become a reliable replacement for traditional…
JSC Retinoids Launches Unique Pharmaceutical Birch Tar Production in Balashikha
JSC Retinoids has organized the production of pharmaceutical-grade purified birch tar in Balashikha, near Moscow. This raw material is critically important for the manufacturing of medicinal and dermatological products. As Regions reports, this is the only facility of its kind in Russia, and its current capacity allows it to fully meet the needs of domestic pharmaceutical companies for this type…