Gedeon Richter Ltd. launches production of Reagila (cariprazine) for patients suffering schizophrenia and bipolar disorder in Russia. Starting from July 26, 2021, the drug will be produced at the GEDEON RICHTER-RUS plant in Yegoryevsk (Moscow Region).
Production of the first commercial series of the already registered original drug Reagila (cariprazine) has been launched at the Russian enterprise of the Hungarian pharmaceutical company. The transfer of full production cycle of drug capsules in four dosages: 1.5 mg, 3 mg, 4.5 and 6 mg, was successfully completed on July 1, 2021.
The first commercial Russian-made batch of Reagila, 1.5 mg, will go to distributors’ warehouses in August 2021, just as it has been scheduled. Start of a 3 mg drug dosage production is expected in November, and as for dosages of 4.5 and 6 mg – in early 2022.
Attila Varady, Authorized Representative of Gedeon Richter in the Russian Federation:
“The Coronavirus pandemic in a situation of closed borders made people realize the importance of localized production, because each country seeks to provide cutting edge treatment primarily to its residents. An uninterrupted supply of drugs is of special importance to those patients who receive them on a regular basis or in long courses. Taking medication on a strict schedule, without interruptions, is an integral part of treatment of such diseases as schizophrenia or bipolar disorder. These diseases are more common than it seems: according to various estimates, bipolar disorder affects from 1.5 to 6% of the population, schizophrenia – about 1%. In Russia these figures mean millions of patients, each of them has the right to a full, active life. Moreover, Russia has always been and remains a key market for Gedeon Richter. That is why we decided to localize at our Russian site GEDEON RICHTER-RUS the production of Reagila – an innovative drug important for patients.
Cariprazine was registered in the Russian market in 2019 under the trade name Reagila and was initially used in patients with schizophrenia. In June 2021, the Ministry of Health of the Russian Federation extended the list of indications for the drug use by including such states of bipolar disorder in adults as manic or mixed episodes, as well as bipolar depression. Besides the EU, other European and CIS countries, the drug is sold in Israel, Thailand, Malaysia and Singapore, as well as in some countries of the Middle East. Cariprazine is currently being studied in the United States as an adjunct to antidepressant therapy in adults with major depressive disorder.
GEDEON RICHTER-RUS JSC is one of the six own factories of Hungarian company “Gedeon Richter” and its first foreign production site. The plant is located in urban district Yegoryevsk (Moscow Region). In 2021, the plant celebrates its 25th anniversary. In 2004, the GEDEON RICHTER-RUS plant became the first pharmaceutical company in Russia to receive a certificate of compliance with European GMP requirements, which the plant successfully confirms every 3 years. Since 2005, GEDEON RICHTER-RUS has been participating in the program of preferential pharmacological support to Russian citizens. Today the plant produces 23 names of medicinal products in various dosages, 12 of which are included in the Essential Drug List. In 2019, the construction of a new prepackaging and packaging workshop with a total area of over 9,000 m2 was started, which commissioning is scheduled to late 2021.
Gedeon Richter headquartered in Budapest (Hungary) is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe, in China and in Latin America. By the end of 2020, the company had a market capitalization of EUR 3.8 billion (USD 4.5 billion) and consolidated sales of approximately EUR 1.6 billion (USD 1.8 billion). The product portfolio of Richter covers multiple therapeutic areas, including gynaecology, central nervous system, and cardiovascular areas. Having the largest R&D unit in Central Eastern Europe, Richter’s original research activity focuses on CNS disorders. With its widely acknowledged steroid chemistry expertise, Gedeon Richter is a world-class expert in the female healthcare. Richter is also active in biosimilar product development.
The assets of Gedeon Richter include eight production and research centers, as well as its own plant in Russia, which was opened almost 25 years ago and became the first foreign production site of the company. As of 2020, Gedeon Richter‘s sales in Russia amounted to about 15% of the total sales in the countries where the company operates. According to DSM Group, Gedeon Richter is one of the TOP-20 pharmaceutical companies leading in terms of sales in the Russian Federation. Gedeon Richter is a socially responsible company, implementing projects in the field of CSR at the global and Russian levels. The social project “Women’s Health Week” by Gedeon Richter has become a striking example of company’s contribution to the campaign of raising the awareness in self-care and reproductive health. Today the company employs almost 13 thousand people worldwide, about 1000 of them work in Russia. www.g-richter.ru