rapharma en 171212 - trade delegation of the russian...
TRANSCRIPT
CJSC “Rafarma” is a multi-purpose pharmaceutical integrated plant for production of all types of pharmaceutical forms of medicinal products of different pharmacological groups, built in the territory of Special economic zone of industrial type “Terbuny” of Lipetsk region. The project was initiated by the Foundation to support health care “HEALTH” and is one of the most ambitious projects of recent years in the Medical Industry of the Russian Federation. The company was among the first included in the Register of promising projects in the pharmaceutical and medical industry of the Ministry of Industry and Trade of the Russian Federation (Order of the Ministry of Industry and Trade of Russia № 909 of 08.10.2009).
The project is implemented with the support of the
Administration of the Lipetsk region, the Ministry
of Industry and Trade of the Russian Federation
and the Ministry of Healthcare of the Russian
Federation, and corresponds to the fundamental
problem “Strategies of development of
pharmaceutical industry of the Russian
Federation for the period up to 2020” - namely,
the creation of modern highly effective production
base which meets the GMP standards and
ensures import substitution and competitiveness
at both domestic and foreign markets.
In late 2009, the State Corporation “Bank of Development and Foreign Economic Affairs (Vnesheconombank)” and CJSC “Rafarma”executed loan agreements on provision of
financing totaling 66 million euros for a period of 7 years, in order to implement the project of construction of the plant for production of antibiotics and anticancer preparations. The facilities are equipped with the latest high-performance automated lines of the world's leading manufacturers of equipment such as
Bosch, Bausch & Stroebel, IMA, Huttlin, GLATT, Edwards, Marchesini, Killian, etc.
ProjectionGMProject – is well-known Czech engineering company with 18 years of experience in developing GMP-production facilities that meet international standards in the field of pharmacy and biotechnology.
TECHNOPROJEKT - was founded in 1951 in the Czech Republic, it is an acknowledged international company in the field of industrial construction.
Construction and engineering support
UNISTAV – is one of the best companies in the Czech Republic in construction of industrial buildings using advanced construction techniques and materials.
M ENGINEERING D.O.O. – is Serbian construction company.
Supply of technological equipmentGlatt GmbH – is one of the well-known German companies in the field of production of
equipment for pharmaceutical production facilities since 1954.
Technocom Engineering GmbH – was founded in 1989 in Germany. Construction and delivery of complex production lines for chemical-pharmaceutical, biological and food industries.
June 7, 2011 the Authorization for commissioning of the facility of the first phase of the plant № RU 48515314-005 was signed. The commissioning of the second phase of the plant took place in September 2012. The Authorization for commissioning of the facility №RU 48515314-007 was received. Based on the issued Authorizations for commissioning of all production facilities the certificates of state registration of rights were
received.
The legal basis for the activity of CJSC “Rafarma” is the following licenses:License for pharmaceutical activity№ FS-99-02-002311 dated 28.04.2012License for production of medicinal products № 11586-LS-P dated 02.05.2012Sterile pharmaceutical forms produced in aseptic conditions (freeze-dried products, powders)Non-sterile pharmaceutical forms (suppositories, tablets)Pharmaceutical substances (obtained by chemical synthesis)Packaging production (primary and secondary packaging):•solid pharmaceutical forms Packaging production (secondary packaging):•Liquid pharmaceutical forms •Soft pharmaceutical forms.
We create affordable medicinal
products that meet international
quality standards, which means
we give people harmony and
confidence in the future.
By 2018, to enter the top three leading Russian manufacturers of antibiotics on overall production in packages.
Occupy not less than 20% of sales volume in the group of preparations planned for production on the Russian pharmaceutical market in 2018.
Ensure a reduction in import of preparations on line items by 30-40%.
Ensure the accordance of nomenclature of the manufactured medicinal products with the
project objectives.
Provide the following annual outputs of produced pharmaceutical forms in 2016:450 million tablets, 180 million hard gelatin capsules, 62.5 million vials of injectable preparations, 18 million “sachet” packages, 7.5 million vials of suspension.
Introduce mandatory training of the stuff to standards of GMP, GOST R 52249-2009 “Good Manufacturing Practice for
Medicinal Products” within implementing in the company of the quality management system on standard ISO 9001:2008
• Provide sales volume of 10 billion rubles ($ 317 million) by 2016
• Provide the level of gross profit of 6.5 billion rubles ($ 216.7 million) and net profitof 2.2 billion rubles ($ 73.4 million) in 2016.
Construction of newefficient sales systems
Creation of an extensive distribution network
Main areas:Moscow, St. Petersburg, Novosibirsk, Yekaterinburg,
Nizhniy Novgorod, Samara, Omsk, Kazan, Ufa, Chelyabinsk, Rostov-on-Don.
Projects startup with foreign pharmaceutical
companies: primary and secondary packaging,
the entire production cycle.
Innovations
The introduction of new scientific developments in the field of medicine
and pharmacy, in cooperation with leading Russian and foreign scientists.
Effectiveness
Carrying out business processes based on a combination of scientific and technological innovation and the extensive experience
gained over the years by the team of professionals on the effective activity on the
pharmaceutical market.
Responsibility
Use of international management and technology standards under the
responsibility of the company to the consumers.
Compliance with ecological standards and reducing the impact on the environment taking into account the
responsibility to future generations.
ASB (АБК) - administrative and service building (3500 m²)
Workshop № 1 – PWB (УСК) - packing and warehouse
building (8500 m²) storage of finished products, packaging products, manufacturing of non-antibiotical
preparations, experimental production facility (1170 m²)
Workshop № 2 - production of cephalosporin preparations (1800 m²). Injectable preparations in vials,
children’s suspensions, tablets and capsules.
Workshop № 3 - production of non-antibiotical
preparations (2400 m²) Injectable preparations in vials, children’s suspensions, tablets and capsules.
Workshop № 4 - production of antibiotics of non-β-
lactam structures (1800 m²) Injectable preparations in the form of solutions in ampoules, tablets, capsules.
Workshop № 5 - production of anticancer preparations
(1000 m²) Injectable preparations in vials.
Electrical power unit - providing workshops with hot
water, steam, electricity).
Production is a multi-purpose pharmaceutical research and production complex with a total
area of 25,000 m².All production facilities meet completely the
requirements of GOST R 52249-2009 “Good Manufacturing Practice for Medicinal Products”.
At various stages of registration in the Ministry of Health
of the Russian Federation are the following:
� Anticancer preparations (5)
� Antimicrobials (20)
� Cardiovascular preparations (4)
� Anti-ulcer preparations (3)
� Neuroleptic agents (3)
� Other (2)
Generic medicinal preparations
Original medicinal preparations
� Preparations based on benzalkonium fluoride, having antibacterial, antiviral and antifungal activity (undergo clinical trials) 8 medicinal preparations
� Combination antibiotic preparations with an inhibitor β-lactamase (creation of biochips to identify the genes responsible for synthesis of proteins that destroy antibiotics) (Pass preclinical studies) 17 preparations
� The original patented devices for medical use (inhaler, injector)
� Development of inhaled powdered ready pharmaceutical forms.
New technologies
� In cooperation with the University n.a. Christian Albrecht (Kiel, Germany), the following works are carried put:
� Development of liposomal forms of antitumour and antituberculous innovative medicinal preparations with desired pharmacokinetic properties (receiving of parenteral preparationsbased on insoluble pharmaceutical substances by encapsulation in liposomes).
� Development of preparations with improved bioavailability based pharmaceutical substances with modified biopharmaceutical properties (production of nanocrystals by grinding in the gas phase and synthetic crystallization).
Our company guarantees the customers the highest standard of quality of the produced
medicinal preparations.
The principles of social policy of the company are brought into compliance with
the state policy of Russia in the field of pharmacological support providing replacing
the expensive imported preparations by domestic agents produced in compliance
with international standards of manufacture at affordable prices.
Our company is focused on investment in creation of new medicinal preparations and improvement of production technology, as an essential component of social welfare of the country is the level of health care and
availability of medicine.
� Worldwide standards of quality and service
� Advanced technologies
� Integrated service delivery
� Individual approach to each client and customer
� Staff with many years of professional experience
� Quick-transformable, zoned factory
� The possibility of formation of new production facilities in the existing space
� Optimal use of space in the production of preparations under conditions of GMP.
From the first days of work the priority area of activity of the company is to develop and manufacture modern and safe
medicinal products that meet the requirements of healthcare and expectations of the patients.
Our customers can be sure that the preparation which he holds in his hands is made in accordance with the requirements of GMPand passed many stages of quality control.
The strategy of the company, professional staff, modern production facilities and our
projects allow us to look forward with confidence and ensure the availability of quality generics and innovative medicinal
products for the Russians.