60 leading Russian reproductologists visited the domestic production of drugs for treatment of infertility at the Medsintez Plant

60 leading Russian reproductologists visited the pharmaceutical company Medsintez Plant in Novouralsk on September 4, 2024. This event was timed to coincide with the celebration of the 3rd anniversary of the opening of the production workshop for biotechnological substances for the reproductive health of women, as well as the Annual International Conference «Reproductive Technologies Today and Tomorrow» in Ekaterinburg. Leading experts and conference speakers visited the production of the first Russian follitropin alpha for the treatment of human infertility, Primapur®.

Since 2018, the Medsintez Plant, in cooperation with iVFarma, has been producing the first Russian drug of recombinant follicle-stimulating hormone (FSH) – Primapur®, which is used for the treatment of human infertility in assisted reproductive technologies. The Medsintez Plant produces the substance of this drug and the finished dosage form in pre-filled disposable syringe pens.

The Russian-made FSH preparation is needed today in order to provide high-tech medical care in the Russian Federation on the way to overcoming the reproductive problems of the population. Within the framework of the Federal Law of November 21, 2011 No. 323-FZ On the Fundamentals of Protecting the Health of Citizens in the Russian Federation, citizens are widely provided with affordable infertility treatment through the in vitro fertilization (IVF) procedure. Primapur® has passed all stages of development and production in the Russian Federation and is included in the list of vital drugs.

The production capacity of Primapur® is up to 30 grams of the substance – up to 1 million disposable syringe pens per year, which is 190 thousand courses of infertility treatment by the IVF method. Thus, the Medsintez Plant is able to meet 200% of the annual demand for FSH drugs in Russia. And this is far from the limit, since if necessary, these indicators can be increased in a short period of time.

Today, the drug is used in more than 80% of medical centers in Russia that specialize in the treatment of human infertility. More than 80 thousand women have already received therapy with Primapur® and more than 24 thousand children have been born.

Solving the issues of import substitution, the Medsintez Plant and iVFarma LLC develop other hormonal drugs used in a complex of assisted reproductive technologies, such as recombinant human chorionic gonadotropin (HCG) and human gonadotropin-releasing hormone antagonists – Cetrorelix and Ganirelix. The creation of a full line of drugs for infertility treatment will ensure drug safety in Russia and allow not to depend on import supplies.

Alexander Petrov, the Chairperson of the Board of Directors of the Medsintez Plant, shared plans for the development of production of drugs for reproductive health: «Over the past 2 years, the demand for domestic drugs has increased due to the current geopolitical and economic situation. Some foreign drugs were delivered with delays and increased in price, and there were also reasonable and unreasonable shortages, since drugs for the treatment of infertility are mainly supplied from the EU countries and the USA. This trend is particularly affecting the infertility treatment, where the treatment cycle lasts up to one month, as well as the support of a developing pregnancy. Thus, fully localized Russian production of drugs for the treatment of infertility and preferences for local manufacturers should protect this sector from price and logistics pressure.»

“Thank you for the opportunity to see the full production cycle of the Russian follicle-stimulating hormone. I am impressed by the scale of the Medsintez Plant and its technical equipment. The production is serious and takes a responsible approach to product quality control. Primapur® has been used in our Center for years and has proven its efficacy and safety. At the plant, we were told about the development of new drugs for the treatment of infertility in the IVF program, which had already been created and would be registered in the next few years. I think that our country will soon be provided with the necessary drugs for a full cycle of ovarian stimulation, which certainly makes me happy,«- shared her impressions Svetlana Perminova, Doctor of Medical Sciences, leading researcher, obstetrician-gynecologist, reproductologist of the Scientific and Clinical Department of ART named after F. Paulsen of the Federal State Budgetary Institution «National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov» of the Ministry of Health of the Russian Federation.

The Medsintez Plant was the first in Russia to start producing a dosage form of FSH convenient for patients in the form of disposable syringe pens, which is a consumer advantage and allows the drug to be used at home. The Primapur® syringe pen is registered with Roszdravnadzor as a medical device.

“Domestic production of drugs for the reproductive health of women is our confidence in the future. The FSH drug Primapur®, the production site of which we have visited, has been used in treatment programs of our patients for several years so far. This is an effective drug that is not inferior to imported analogues and fully meets all safety requirements. Today, we have seen the production of this drug from the substance to the finished dosage form. The technologically advanced production, cleanliness, people and personnel who care about their work, and serious quality control are amazing. This pharmaceutical plant may be one of the largest I have ever visited, thank you for the invitation!» — said Marina Shcherban, head of the ART Department of the Center of Reproductive and Cellular Medicine, obstetrician-gynecologist, reproductologist of the City Clinical Hospital for Children of the city of Krasnodar of the Ministry of Health of the Krasnodar Territory.

High-tech Russian production at the Medsintez Plant ensures a high level of quality and safety of manufactured medicines. At the same time, domestic production of medicines does not depend on rate fluctuations, which means that it offers favorable prices for finished products in comparison with imported analogues.

Today, the products of the Medsintez Plant are in demand throughout the country; the production capacity of the enterprise is capable of meeting 100% of the country's needs for vital insulin medications and drugs for the treatment of infertility, as well as providing serious support to the country during epidemics and pandemics of viral infections.

Over the past two years, the company has launched the production of entire lines of new drugs. In 2023, the plant launched the production of a full cycle of hypoglycemic agents — GLP-1 receptor agonists for the treatment of type 2 diabetes, and also launched the production of the first Russian veterinary insulins separately for cats and dogs. In 2024, Medsintez Plant launched full-cycle production of the world's first registered drug of recombinant human albumin for widespread use in medicine.