JSC Farmak pharmaceutical company (Kyiv) has launched the project “Electronic dossier of a series of medicinal products,” upon completion of which paper-based records of information on the production of a series of medicines will be completely replaced by electronic ones. According to the company’s press release, the project partner was Siemens, which introduced similar systems for the pharmaceutical companies Bayer, Johnson & Johnson, Takeda, etc.
The electronic dossier of a drug batch includes all the necessary protocols: from quality control of raw materials to information on all stages and parameters recorded during the manufacture of the drug.
The company clarifies that the introduction of an electronic dossier minimizes the risk of operator error, optimizes the technological process and allows real-time monitoring of the situation at the site, and also provides complete statistics for calculating the overall efficiency of the equipment
In addition, the electronic dossier allows an authorized person to analyze online all indicators of the drug for deviations and release a batch of the drug remotely, from anywhere in the world.
“Digitalization is a requirement of our time. As every citizen of Ukraine has an electronic passport, so each series of drugs should have its own electronic dossier. We are interested in the deep processes of digitalization, so we introduce electronic quality certificates, electronic research protocols, electronic dossiers of drug series and much more,” Executive Director of JSC Farmak Volodymyr Kostiuk said.
Farmak is the leader of the Ukrainian pharmaceutical market, produces medicines in all 14 therapeutic groups. Among the main directions are endocrinological, gastroenterological, cardiological, neurological, anti-cold and other drugs. Annually it introduces to the market about 20 new complex component modern drugs. Currently, the company’s product portfolio includes about 400 drugs.
The pharmaceutical company PJSC Farmak (Kyiv) has confirmed the compliance with the GMP of the Eurasian Economic Union (EAEU), which is a prerequisite for registration/re-registration and sale of drugs in the markets of the EAEU member countries, in particular in Belarus, Kazakhstan, Kyrgyzstan.
According to the company’s press release, the inspection of the pharmaceutical company at the beginning of 2021 was carried out by representatives of the Republic of Belarus, who checked production, warehouse, laboratory facilities and the functioning of the pharmaceutical quality system.
“The presence of the EAEU certificate becomes a prerequisite for the registration/re-registration and sale of drugs in the markets of the EAEU member states (Belarus, Kazakhstan, Kyrgyzstan, etc.) and will reduce the number of inspections carried out by local regulatory bodies of the EAEU member states,” a press release says.
The company is currently preparing to be tested for compliance with the FDA to enter the U.S. market, executive director of the Farmak company Volodymyr Kostiuk specified.
The company recalled that in 2020 the drug Dexamethasonum, which the company produces, successfully passed the WHO prequalification and is included in the list of drugs with confirmed quality and effectiveness in the treatment of HIV/AIDS and COVID-19.
As reported, Farmak at the end of 2020 increased the share of exports to 29.6% in total sales. Export deliveries by the end of the year increased by 40%.
Farmak pharmaceutical company (Kyiv) in 2020 increased the share of exports to 29.6% in total sales.
According to the company’s press release, export deliveries increased by 40% by the end of the year.
Farmak exports its products to the EU, Central and South America, the CIS, the Middle East, Asia, and others – a total of 35 countries around the world.
As the company notes, with the onset of the pandemic, the demand for drugs used in the complex therapy of patients with COVID-19 has grown sharply around the world. In particular, the matter concerns corticosteroids, relaxants, analgesics, antibiotics, as well as drugs for anesthesia and sedation, which are necessary when connecting patients to ventilators.
“A number of such drugs by Farmak have been exported to Israel, Great Britain, Sweden, France, Germany, Poland, Australia, New Zealand, Mexico and Singapore, as well as shipped for the WHO use,” the company said.
Farmak production lines, besides national ones, have European GMP (Good Manufacturing Practice) certificates. This allows products to be sold in countries with particularly stringent regulatory requirements.
“Now we are preparing to undergo FDA inspection to enter the U.S. market. Our strategic goal is to increase the share of exports in total sales to 40%,” Volodymyr Kostiuk, the executive director of the company, said.
Farmak is the leader of the Ukrainian pharmaceutical market, it produces medicines in all 14 therapeutic groups. Annually it introduces to the market about 20 new complex component modern drugs. Currently, there are about 100 drugs in development.
Farmak is a member of the Manufacturers of Medications of Ukraine association.
The pharmaceutical company Farmak (Kyiv) is intensifying the development of digitalization in order to scale up its business and build up its presence in world markets.
“Farmak is one of the largest exporters of domestic medicines. To scale up the business and build up its presence in the world, the company digitalizes all production and management processes. A transparent IT system for reporting, budgeting, production planning, sales, workflow, personnel assessment and training has been implemented at Farmak,” the company said in a press release.
According to Chief Information Officer at Farmak Denys Krestov, Farmak focuses on deep industrial digitalization processes.
“We are gradually switching to electronic quality certificates, electronic research protocols, electronic dossiers, e-serialization of products, and so on. Every day the system administration department maintains 30 physical platforms and more than 150 virtual ones that support the operation of business applications,” the company’s press service said, citing Krestov.
Farmak is the leader of the Ukrainian pharmaceutical market, produces medicines in all 14 therapeutic groups.
Over the past five years, Farmak’s investments in the scientific and technical complex, production equipment, and research activities amounted to UAH 3.4 billion.
JSC Farmak is a member of the Association of Manufacturers of Medications of Ukraine (AMMU).
Biopharma pharmaceutical company has sent UAH 6 million to buy equipment for the reference laboratory of the Public Health Center, which will be used to diagnose the coronavirus disease COVID-19.
As the company told Interfax-Ukraine, the equipment will allow quickly determining the presence or absence of the coronavirus disease pathogens in the samples obtained, using modern methods.
The first unit is Thermo Fisher Scitific Nucleic automatic acid extraction workstation with consumables for 20,000 samples. It helps prepare samples for analysis.
The second unit is Bio-Rad CFX 96 PCR detection system, which already directly determines the DNA of the virus, as well as test systems for it.
The equipment was purchased at the initiative of Biopharma co-owners Kostiantyn Yefymenko and Vasyl Khmelnytsky.
The Public Health Center said that the number of samples sent for verification is growing daily, so new equipment will allow quick testing.
The complex, which will be launched on Saturday, allows processing up to 100 samples in 60 minutes that is, up to 2,000 per day.
Earlier, Biopharma transferred the necessary equipment for UAH 5 million for the Bila Tserkva hospital three. In total, Biopharma sent more than UAH 11 million to support measures to combat the spread of COVID-19.
Germany’s STADA pharmaceutical company is acquiring pharmaceutical business of prescription and OTC preparations of Biopharma blood product manufacturer. According to a STADA press release on Monday, Biopharma’s pharmaceutical business will become an integral part of STADA in Ukraine and has strong growth potential in the production of high-quality prescription and OTC drugs. The agreement provides for the acquisition of production facilities in the city of Bila Tserkva (Kyiv region).
Biopharma shareholders will preserve the company’s plasma processing business and focus on its development both in Ukraine and abroad. To acquire it STADA must obtain permission to merge in Ukraine.
The transaction is expected to close in December 2019.
STADA’s Ukrainian business will be led by newly appointed CEO Borys Labensky.
Biopharma President Kostyantyn Efymenko, together with partner Vasyl Khmelnytsky and financial investors, will focus on developing the Biopharma plasma processing business, developing the new Biopharma plasma fractionator and a network of modern blood collection centers and expanding its presence in international markets.