Probity
Passion
Cure
Specialty pharmaceutical company focused on commercialisation of unlicensed medicines, orphan drugs and specialty therapeutics
Specialty
pharmaceutical company
Company
Specialty pharmaceutical company
Our paramount concern is for patient welfare, and we are committed to providing sustainable access to innovative therapeutic and diagnostic solutions. We identify critical success factors which enable us to facilitate fast-track market access while upholding the highest ethical and regulatory standards.
- Import and distribution of unlicensed products
- Consulting services
- Access to original and innovative medicines
Services
Probity. Passion. Cure.
Unlicensed medicines
Our wholesale company specializes in the delivery of non-registered products to end-users, including niche, orphan drugs, and products experiencing shortages in specific markets.Read more
Unlicensed medicines i
Our wholesale company specializes in the delivery of non-registered products to end-users, including niche, orphan drugs, and products experiencing shortages in specific markets.Read more
Registration of medicines and medical devices
Our regulatory services are comprehensive, covering the entire process of product registration/maintenance of marketing authorization and all necessary interactions with Competent Authorities prior to product launch.Read more
Registration of medicines and medical devices
Our regulatory services are comprehensive, covering the entire process of product registration/maintenance of marketing authorization and all necessary interactions with Competent Authorities prior to product launch.Read more
Access to original and innovative medicines
We establish Managed Access Programs for innovators, our aim is to efficiently capture and fulfil requests for access to innovative medicines in non-launched markets, handling market access (securing reimbursement and obtaining the right price).Read more
Access to original and innovative medicines
We establish Managed Access Programs for innovators, our aim is to efficiently capture and fulfil requests for access to innovative medicines in non-launched markets, handling market access (securing reimbursement and obtaining the right price).Read more
Mission and Values
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News
Expert meeting on neuroblastoma
We are extremely proud to have supported and sponsored an expert meeting where the main topic was the treatment of high-risk neuroblastoma.
Company history
As a specialized pharmaceutical company, we have maintained a strategic approach to growth since our establishment, ensuring the realization of our full potential through careful planning and management.
The company acquired exclusive distribution rights with new principal from EU and began distributing two new niche medicines, for treatment of patients with acute lymphoblastic leukaemia (ALL) and an antiviral agent with broad spectrum activity inhibiting the human virus of the herpes group, including HIV at concentrations not affecting cell growth. We identified a potential shortage of antivenom serum in the EU markets and established cooperation with the Institute of Virology, Vaccines, and Sera “Torlak”. We successfully exported their product VIEKVIN® to the markets of Germany, Austria, and Italy and incorporated the entire Torlak portfolio into our offering. We commenced with activities and projects to expand cooperation in other markets.
Glutathione therapy and bringing experts together to advance neuroblastoma treatment
The company began with distribution of glutathione therapy that helps patients whose tissue and intracellular levels of endogenous glutathione have been reduced by chemotherapy drugs, exacerbating the tumor condition caused by oxidative stress. Preclinical and clinical studies have demonstrated the protective role of glutathione in many pathological situations that cause cellular damage. In the same year, the company imports and distributes nationwide a therapy that reduces the incidence of hemorrhagic cystitis caused by the action of cyclophosphamide and ifosfamide. The therapy helps protect the bladder lining from the harmful effects of these two drugs, which the body breaks down into substances that can damage the bladder. The company sponsored an expert meeting in Belgrade, where the main topic was treatment of neuroblastoma in children with domestic and international experts, where the latest research results in this field were presented and previous experiences were shared in order to improve the future application of the therapy for this rare disease.
Combatting COVID-19: Innovative therapeutic and diagnostic solutions for rapid detection and prevention
With the emergence of global pandemic, the company focused on finding therapeutic and diagnostic solutions to relieve the burden of transmission of the COVID-19 virus. In addition to the introduction of certain therapies used in the COVID-19 protocols, the company became marketing authorization holder of innovative test kits, for the rapid detection COVID-19 infection, the first of their kind to be approved for self-testing in the market. The company introduced a brand of BCG vaccine, which is used for the treatment of existing bladder tumours and for the prophylaxis of recurrence. This immunotherapy is applied after transurethral resection of superficial tumors with the aim of preventing recurrence. Therapy is very deficient in the country, and irregular application of this therapy can increase the chance of disease recurrence.
Exclusive Distribution of an orphan drug
The company begun with the delivery of targeted immunotherapy for a rare disease and obtained exclusive distribution rights for this innovative and original medicine used to treat high-risk neuroblastoma, a rare disease – rare form of cancer arising from neural crest cells, the most frequently occurring solid tumour in infants under one year old. This innovative medicine, which is becoming the standard of care in the treatment of high-risk neuroblastoma, is now available in Serbia, marking a vital step forward in treating young children diagnosed with this aggressive type of cancer. The company has become a member of the group of wholesalers within the Serbian Chamber of Commerce, which holds full membership status in GIRP – the European Healthcare Distribution Association.
Introduction of new generic medicines
Company successfully introduced new generic brand of medicine that treats brain tumours and cancers that have spread elsewhere in the body (metastatic brain tumours), types of cancer that originate from white blood cells (Hodgkin’s lymphoma and non-Hodgkin’s lymphomas) and is also used as a “conditioning” treatment before transplantation of the patients own haematopoietic progenitor cells. Another new generic brand medication that is used to treat rheumatoid arthritis was also placed on the market.
Extended reach in medicines supplyy
The company realised it’s first supplies to the neighbouring markets. Completed implementation of ISO:9001 2015 QMS standard.
Porfolio and therapeutic area expansion
The company expanded therapeutic areas in which it is present to: haematology, cardiology, neurology, infectious diseases, anaesthesia, gastroenterology and psychiatry.
First supply and implementation of QMS
The company signed agreements with the most eminent health care centres in Belgrade and throughout Serbia. Started distribution to end users and also obtained and implemented ISO:9001 2008 QMS standard.
Establishing a strong portfolio
Through depth market analysis the company identified niche pharma products for placement on the market, with the focus on oncology and orphan drugs. Company completed registation in the register of bidders within the Serbian Bussines Registers Agency.
Obtained a WDL
The company was issued a wholesale dealers license by competent Authority – Ministry of Health. Guidelines for good practice in the distribution of human medicines have been adopted pursuant to Article 84 and Article 85 (b) (3) of Directive 2001/83 / EC and brought by Serbian MoH and published in “R Serbia Official Gazette” in 2016 but the Ministry is not issuing separate GDP certificate, by issuing WDL it is understood that wholesaler operates in accordance with GDP guidelines.
Company
Social Responsibility & Ethics
We are passionate about supporting the Aurora2222 workforce by providing our employees with a wealth of opportunities to grow, develop and thrive, including actively supporting employee volunteer service efforts.