On May 27, a delegation led by Cuban Deputy Minister of Health Dr Marcia Cobas Ruíz visited the GEROPHARM production site. This is further step in developing the company’s presence in the Latin America region.
High-ranking visitors also included representatives from the State Ministry of Health, the Center for Genetic Engineering and Biotechnology (CIGB), the Biocubafarma Group and the Republic Embassy.
During a tour of the company’s plant in Pushkin, delegates were able to get acquainted with the arrangement of modern high-tech pharmaceutical production, as well as make sure that the GEROPHARM site fully complies with GMP quality standards, is fitted with equipment from leading manufacturers, and has 90 % of its processes automated. It is worth noting that the manufacturing capacity of the insulin production line at the plant in Pushkin is 1,000 kg of substance per year, which, after reaching the design capacity, will allow to fully satisfy the needs of Russian residents in insulin (about 800 kg per year) and will expand the company’s export capabilities.
Within the framework of the business agenda, the GEROPHARM presence prospects in the Cuban market were discussed.
Pyotr Rodionov, GEROPHARM CEO: “We are always glad to welcome visitors at the GEROPHARM production sites. For our visitors, it is all about the opportunity to assure themselves of the impeccable quality of our products, and for us it is all about demonstration of our capabilities and business potential. This April, we took the first step to open the Cuban market and start exporting high-quality drugs to the Latin America region. Now we continue to strengthen business ties in the country. We are confident that we will be able to use our experience to significantly develop an export-oriented business model and increase our presence in the region by entering other markets.”
It is worth reminding that in April GEROPHARM submitted a case file to register all forms of presentation of human genetically engineered insulins Rinsulin® R and Rinsulin® NPH – bottles, cartridges and disposable pen injectors – to the Cuban national regulatory authority CECMED*.
CECMED has extensive expertise in drug registration and auditing. For instance, Cuban GMP is recognized in the Latin American region as a confirmation of product quality and evidence of manufacturer reliability for some other countries in the region. The Cuban market has good development prospects in terms of biotechnology and production localization. The country has already created an appropriate infrastructure, as well as proprietary developments and willingness to cooperate with foreign manufacturers.
Currently, the country market is represented mainly by human genetically engineered insulins. The need of the population for these socially significant medicines is provided by the state.
Diabetes mellitus is an important problem in Latin America. According to the IDF data for 2017, the number of patients in the region was estimated at 26 million people, and this figure is constantly growing. The predicted value of patients by 2045 is 42 million people (+62 %). In terms of costs associated with this disease, Latin America is one of the leading regions among developing countries: 29.3 billion USD per year**. Some states, such as Brazil, Argentina and Mexico, have developed pharmaceutical industries. At the same time, Brazil, Chile, Argentina and Cuba are characterized as the most authoritative regulators in the region, and obtaining registration in these countries confirms the compliance of drugs and case files with the highest requirements.
* CECMED – Center for State Control of Medicines, Equipment and Medical Devices of Cuba
** IDF DIABETES ATLAS, Eights edition 2017
GEROPHARM is a national manufacturer of biotechnological products providing for medicinal safety of Russia. The company is engaged in full production cycle of drugs, invests into technological development and creation of a modern pharmaceutical infrastructure. Fields of GEROPHARM expertise: psychoneurology, ophthalmology, endocrinology and gynecology. The company is expanding its product portfolio – in its proprietary R&D center, drugs are being developed for treatment of socially significant diseases. Today GEROPHARM is the only one Russian manufacturer of insulin, produced on a full-cycle basis. It covers 30 % of demand for genetically engineered insulins in the RF. The Company has been occupying the first position by sales volume among the manufacturers of human genetically engineered insulin monomolecules since the end of 2016. Both company plants – in Obolensk (Moscow Oblast) and Pushkin (St. Petersburg) have the capacity to produce this socially significant drug. Since 2011, the company portfolio includes two human genetically engineered insulins – Rinsulin® R and Rinsulin® NPH, 7 more products are being developed (insulin analogues and HGEI), 4 of which are already at the registration stage in Russia.