Acino’s manufacturing plant in Ukraine—Pharma Start—has successfully been certified according to the Good Manufacturing Practice of the European Union (EU GMP) by the State Agency of Medicines of the Republic of Latvia.
Acino obtained a three-year certificate covering drug manufacturing (solid capsules, tablets), primary and secondary packing, and quality control (microbiological: nonsterile; chemical/physical). Acino’s new GDP certificate has been listed in the EudraGMDP database.
EU GMP is a mandatory standard for the certification of pharmaceutical production in Europe and is globally accepted. The GMP standard outlines the requirements for quality management systems, personnel management, equipment used, production facilities, and documentation.
‘The Swiss pharmaceutical group Acino values high standards of quality in all business processes, so the certification of production in accordance with the EU GMP standard is a significant and sought-after achievement,’ explained Eugene Zaika, Acino’s Regional Head Ukraine and CIS. ‘Ever since Pharma Start was acquired by Acino in 2015, we have been constantly improving our quality system and introducing innovative production technologies to ensure safety, efficiency, and consistently high product quality and manufacturing sustainability.’
‘Acino has invested over EUR 13 million in our manufacturing plant in Ukraine since 2015, focusing in production modernization, R&D, quality systems and energy-efficient solutions. The EU GMP certification demonstrates that Acino products manufactured in Ukraine meet the EU’s strict regulatory requirements and opens the door to new opportunities in markets across the world,’ added Zaika.
The EU GMP complements the GMP certification obtained in 2004 from the Ukrainian Authorities and the ISO 22000 Food Safety Management System certificate that Pharma Start received in 2018, which combines the requirements of ISO 9001 and HACCP for the development, production, quality control, sales, and transportation of dietary supplements.
Acino aspires to become a preferred brand for patients and healthcare professionals in emerging markets. Compliance with EU GMP requirements and ISO standards guarantees the high level of quality, efficiency, and safety of Acino products during development, manufacture, storage, distribution, and post-marketing activities.
Acino is proud to have been recognised as the Best Pharmaceutical Company 2019 by the Armenia Diaspora association in Armenia for our contribution to the development of the country’s pharmaceutical industry, our high-quality medicines and successful cooperation with the Armenian healthcare community.
“We are grateful for such high assessment of our work and this prestigious award. Acino will continue to provide high-quality medicines for the population of Armenia and extend its product portfolio in therapeutics areas such as neurology, psychiatry, cardiology and endocrinology.” Mikayel Tovmasyan, Head of Acino Armenia. “We also plan to cooperate more closely with the healthcare community on educational projects and programs for doctors.”
Each year, the Armenia Diaspora Association celebrates contributions to society made by organisations or individuals.
In October 2015, Acino acquired Pharma Start, which is today the 7th largest local pharmaceutical production company in Ukraine. The summary after over two years is impressive with tremendous changes across all functions and the complete overhaul of the commercial structures.
We built a strong team who is willing to go the extra-mile and takes actions to transform the local company into an international market leader. In a very short time frame we completely re-shaped the organizational structure of Pharma Start including the implementation of new functions and significant investment in our people by education and training.
Eugene Zaika, Regional Director Ukraine/CIS
Acino’s business shows remarkable growth numbers and is in 2018 the second fastest growing pharmaceutical company in Ukraine with market leading production in Neurology and Cardiology.
The site in Kyiv is our regional headquarter and home to over 700 employees with the commercial organization and the GMP-certified manufacturing plant. The plant is equipped with modern machinery like Bohle, Huttling, Kilian, IMA, York, and Buderus, and is operational since 2003.
The wind of change at Pharma Start blows strongly with initiatives like a new compensation framework and transparent rules for all employees, the implementation of our compliance policies and pharmacovigilance, the shaping of a new functions, and the investment into new laboratories and manufacturing equipment to name only a few among many others.
The working approach at Acino Pharma Start has changed as it became transparent, ethical and compliant since we joined Acino.
Nataliia Snimshchikova, Human Resources Director Ukraine
Representatives from all over Ukraine honored the results of the great team work at Acino Pharma Start by two awards for the best products of the year at the annual professional contest of the pharmaceutical industry of Ukraine – “Panacea 2016”.
The high performance assessment of “Panacea 2016” shows that Acino Pharma Start is on the right path.
These achievements are the result of continuous hard work of our employees who make a considerable contribution to the development and prosperity of the company and increase the level of confidence in our products among patients, doctors and other professionals of the pharmaceutical industry.
Eugene Zaika, Regional Director Ukraine/CIS
The competition Panacea is organized each year on the Day of the pharmacist and brings together all members of the pharmaceutical market who are operating in Ukraine: local and foreign manufacturers of medical products, distributors, pharmacists and others. The Panacea Award is a professional prize among the participants of the pharmaceutical market of Ukraine.
The aim of the competition is to mark the company which made the most significant contribution to the provision of medicines to patients in Ukraine. We are proud to say that Acino Pharma Start is part of these companies.
At the ceremony held on September 8, 2016, in Kiev, the antihypertensive DIOCOR and the anti-parkinsonian LEVOCOM of Acino Pharma Start were recognized in the category “Product of the Year” in the group of prescription drugs.
The rating of the winners in the category “Product of the year” is the result of market research in the second half of 2015 and the first half of 2016 provided by analytical partners of the Panacea 2016 competition. The medicines were studied according to the international ATC classification1 and winners were determined by the following indicators: The proportion of the drug in its segment and the dynamics of growth in retail sales pricing in a competitive segment.
1 The Anatomical Therapeutic Chemical (ATC) Classification System is used for the classification of active ingredients of drugs according to the organ or system on which they act and their therapeutic, pharmacological and chemical properties. It is controlled by the World Health Organization Collaborating Centre for Drug Statistics Methodology (WHOCC), and was first published in 1976.
In early July 2017, Acino has signed the exclusive distribution agreement with Merck, a leading science and technology company, for commercial sales and promotion of a number of Merck’s drugs in Ukraine, Armenia, Azerbaijan, Kazakhstan, Kyrgyzstan, Moldova, Turkmenistan, Tajikistan, Uzbekistan, Georgia, Belarus and Mongolia.
Starting early 2018, Acino will commercialize 9 products of Merck for the treatment of cardiovascular and endocrine diseases (diabetes mellitus and thyroid gland diseases) in addition to its own products in the region. The following new products are covered by the agreement: CONCOR®, CONCOR® COR, LODOZ®, GLUCOPHAGE®, GLUCOPHAGE® XR, GLUCOVANCE®, EUTHYROX®, JODBALANCE®, THYROZOL®.
Partnerships are integral part of our strategy. The existing high demand for Merck’s products will strengthen Acino’s position in CIS countries and Mongolia quickly and accelerate growth of our business.
Kalle Känd, CEO Acino
Acino expands its presence in the region by creating new jobs locally, in order to ensure continuous access of drugs to the markets of developing countries.
In accordance with our development strategy, we continue to strengthen our product portfolio and put high-quality products on the domestic market, in order to improve the quality of life of patients. Acino’s partnership agreement with Merck is providing access to innovative medical products not only for Ukrainian patients, but also for patients from other CIS countries and Mongolia. I am sure, we will become a reliable partner for one of the world leaders in the development and production of high-tech drugs.
Eugene Zaika, CIS Regional Head Acino
Acino in Ukraine, CIS region and neighbouring countries
Acino’s business across the CIS region and neighbouring countries covers Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Ukraine and Uzbekistan.
Acino established its footprint in Ukraine by the acquisition of manufacturing plant Pharma Start in October 2015 and significantly expanded its business in 2018 with the commercialisation of nine Merck products for the treatment of cardiovascular and endocrine diseases in the above mentioned CIS and neighboring countries. The company since has achieved double-digit growth year-on-year.
The headquarters of Acino’s business in the CIS region and neighbouring countries is located in Kyiv with its EU GMP-certified manufacturing plant equipped with a R&D laboratory.
Acino’s Pharma Start facility is certified according to the ISO 22000 Food Safety Management System standard, which combines the requirements of ISO 9001 and HACCP for the development, production, quality control, sales, and transportation of dietary supplements.
Acino commercializes a leading and patented portfolio of medicines, dietary supplements and medical products in the region covering the therapeutic areas of Cardiovascular, Gastroendocrinology, Endocrinology, Oncology, Central Nervous System (CNS), Women Health, Pediatry and Over-The-Counter products (OTC).
V. Havela Blvd. 8
Regional Head Ukraine and CIS
Phone +38 044 281 23 33