Analysis of the registration and manufacturing of heparin drugs in Russia

Objective. To analyze the circulation processes of heparin group drugs for 2004–2024 from the point of view of the rates of registration and localization of production of active pharmaceutical substances (APS), finished dosage forms, and prospects for implementing a full production cycle in Russia.

Materials and methods. An analysis of information from 693 registry entries in the State Register of Medicines dedicated to heparin-based drugs was conducted, and a database was compiled in Microsoft Excel. Information on registered drugs was classified according to their belonging to the heparin group, the name of the APS, dosage form, date of registration, presence in the list of vital and essential drugs, country of manufacture of the APS, and finished dosage forms.

Results. In accordance with the anatomical-therapeutic-chemical classification, more than 20 names of drugs were classified as heparin group drugs: unfractionated heparin, low-molecular-weight heparin, heparinoid, and antithrombin III. 95 current registration certificates (hereinafter referred to as RC) and 13 RC excluded from the State Register of Medicines were studied — a total of 108 RC. Graphs were constructed to reflect the rate of drug registration in each named group. The highest rates of registration are observed in the period from 2020 to 2024 — on average 5.25 drugs are approved per year. The years with the most active registration were 2011 (11 approved drugs), 2017 (8 approved drugs), and 2023 (9 approved drugs). The production localization of heparin drugs for 2024 is presented in the diagrams. The main country producing APS for heparin drugs is China. However, for every fifth heparin drug, the full production cycle can be performed in Russia, including the synthesis of APS.

Conclusions. Information was received on the structure of the product range (95 drugs are presented in 10 dosage forms for 5 different routes of administration), rate of registration of drugs in the heparin group, and localization of production of the APS, finished dosage form. The production of APS for sodium heparin is concentrated in China. Information is known about the construction in the coming years in Russia of three production sites for the production of the APS of sodium heparin: by the Chinese company “Hebei Changshan Biochemical Pharmaceutical”, the Russian company’s “Pharmasyntez-Kama” and “Severnyj ocean”. At present, only Russian companies are declared to be suppliers of APS is 3 drugs. Heparin drugs are mainly produced in Russia (75.4 % for sodium heparin drugs and 65.1 % for low-molecular-weight heparin).

1. ATC/DDD Index 2024 (Norwegian Institute of Public Health WHO Collaborating Centre for Drug Statistics Methodology). Режим доступа: https://atcddd.fhi.no/atc_ddd_index/.

2. Decision of the Council of the Eurasian Economic Commission No. 89 of 03.11.2016 "On approval of the Rules for conducting research on biological medicinal products of the Eurasian Economic Union" Режим доступа: https://docs.eaeunion.org/docs/ru-ru/01411954/cncd_21112016_89

3. Order of the Government of the Russian Federation of 12.10.2019 N 2406-r "On approval of the list of vital and essential drugs, as well as lists of drugs for medical use and the minimum range of drugs required to provide medical care" (as amended on 16.04.2024). Режим доступа: https://www.consultant.ru/document/cons_doc_LAW_335635/

4. State Register of Medicines. Режим доступа: https://grls.minzdrav.gov.ru/default.aspx

5. GxP news: "Chinese pharmaceutical company plans to launch heparin production in Bashkiria". Режим доступа: https://gxpnews.net/2023/04/kitajskayafarm-kompaniya-planiruet-zapustit-proizvodstvo-geparina-v-bashkirii/

6. GxP news: "Pharmasintez to build a plant for the production of heparin pharmaceutical substance in Tatarstan". Режим доступа: https://gxpnews.net/2024/10/farmasintez-postroit-zavod-po-vypusku-farmsubstanczii-geparina-v-tatarstane/

7. GxP news: “Production of the pharmaceutical substance sodium heparin in the Moscow region will begin in 2024.”. Режим доступа: https://gxpnews.net/2023/06/proizvodstvo-farmsubstanczii-geparina-natriya-v-podmoskovenachnetsya-v-2024-godu/