From generics to the production of biological products and the synthesis of substances

In recent years, the Kazakh pharmaceutical industry has taken a huge step forward. Progress is obvious, because 20-25 years ago there was practically no own pharmaceutical industry in the republic. The enterprises operating at that time were far from international standards and produced a very limited range of obsolete drug products. The lion’s share of the market was occupied by foreign-made drug products, which literally poured into the country after the collapse of the Soviet Union. Then there really was a need; There could be a shortage of some drug products,. Over the years, the situation in the pharmaceutical industry has changed. In accordance with the standards of GMP (Good Manufacturing Practice, the system of rules regarding the manufacturing of drug products), new pharmaceutical enterprises were designed and rebuilt from scratch. Foreign investors came to the industry, which initially focused on the production of competitive products. The head of one of these enterprises, the CEO of NOBEL AFF, Mr. Selcuk Tanriverdi spoke about the achievements and opportunities of Kazakhstan pharmaceutical industry.

- Mr. Selcuk, Nobel AFF JSC is one of the largest Kazakhstan pharmaceutical enterprises, tell briefly about its history and current achievements.

- “NOBEL Almaty Pharmaceutical Factory” is part of the Nobel Pharmaceuticals Group of Companies, which is one of the leaders of the Turkish pharmaceutical industry. The enterprise in Kazakhstan was established in 2002 on the basis of the Almaty pharmaceutical factory. Since its existence, more than 70 million US dollars have been invested in its creation and development. In accordance with the standards of Good Manufacturing Practice (GMP), a complete reconstruction and re-equipment of the existing production premises was carried out. In addition, new workshops (departments) were created, equipped with modern equipment. With the development of production expanded the range of products. Today it has more than 250 trade names of drug products of various pharmacotherapeutic groups. These are antimicrobial drugs, antibiotics, analgesic, antipyretic, anti-inflammatory, antihypertensive, neuropsychiatric, oncological drug products. The company manufactures products in the form of tablets, capsules, creams, ointments, syrups.

Currently, the production capacity of JSC "Nobel AFF" is 750 million tablets per year, 250 million capsules, 20 million bottles of syrup and suspension, 10 million tubs of creams and gels.

- What is the key to the quality of the products?

- It should be noted that JSC "Nobel AFF" is the first pharmaceutical company in Kazakhstan, which began to work in accordance with the standard of Good Manufacturing Practice (GMP). It is also the first to pass inspection and confirmed the compliance of the production conditions with this international standard. It was back in 2011. It should be especially noted that this inspection was held with the participation of experts from the World Health Organization (WHO), who praised our company.

Since then, Nobel AFF has repeatedly received inspections of both regulatory agencies and transnational pharmaceutical companies, which subsequently placed in our factory contract manufacturing of their original innovative drug products. It is important to note that such companies choose factories very carefully and rigidly, because they will never risk their reputation.

- What projects of contract manufacturing are currently being implemented?

- Nobel AFF JSC carried out a contract manufacturing project with a transnational pharmaceutical company — Abxott Products Operations AG of third-generation vasodilator drug, a Moxonidine 0.2 mg and 0.4 mg (trade name Physiotens®).

- What share in the market volume belongs to domestic manufacturers of drug products?

- Just 10 years ago, only foreign companies took leading positions at the market. Today the situation has changed dramatically. Domestic manufacturers progressively increase sales of products and their share in the market volume is growing, respectively. Now, large Kazakh companies are consistently included in the TOP-10, and some even top the rating.

According to the report of the international analytic company IQVIA, in the first half of 2018, compared to the same period in 2017, their share increased in value terms by 4% from 30.1 to 31.3 billion tenge, and in physical terms — by 8.6 % from 96.1 to 104.4 mln packages. As a result, in the first half of 2018, the share of domestic pharmaceutical manufacturers in the value of the market reached 14.2%, and in physical volume — exceeded 32%. It should be noted that this is happening against the background of stagnation and even a reduction in the volume of the Kazakhstan pharmaceutical market.

Of course, in many respects, the success of Kazakhstani producers contributes to the support that they receive in government procurement. And here it is important to note that this is absolutely normal. Give me a state that is not interested and does not support local production? This is a guarantee of economic stability. All countries do it.

But we are not only increasing our presence in the public procurement sector, but systematically increasing sales in the pharmacy segment, where we work without any support, on a par with other market participants. Thus, in the first half of 2018, domestic pharmaceutical companies demonstrated the highest rates of sales growth, which significantly outpaced the growth of the pharmacy segment as a whole — in value terms they increased by 12.7%, in packages by 13.9%.

Nobel AFF JSC consistently takes the second position among domestic companies, and also confidently rises in the overall rating of manufacturers present in the Kazakhstan pharmaceutical market. According to IQVIA, at the end of 2017, Nobel AFF JSC with a share of 3.7% took the 4th position in the market.

- Why is it important that the country has its own pharmaceutical industry?

- The presence of any production is generally important for the country. It gives economic sustainability. A developed pharmaceutical industry ensures the availability of drugs, which is especially important when it comes to life-saving drugs. It makes a huge contribution to the economy, the development of personnel, medical and pharmaceutical science. We are directly interested in the availability of highly qualified specialists and will always invest in their development and growth.

- How many employees work in the company?

- Today, our company employs more than 500 highly skilled specialists. We are investing heavily in training and staff development. There was a period when there were no staff at all in the country who knew and could work according to the standards of good pharmaceutical practices. They were not prepared by any university. We trained our specialists with the assistance of the best experts with practice at our headquarters in Turkey. As a result, we have a cohort of Kazakhstani specialists who are highly skilled and even participate in the development of EAEU legislation in the field of drug circulation regulation.

- What countries are your products delivered to? Tell us a little about your export strategy.

- Our production is focused not only on the domestic market. We supply products to Kyrgyzstan, Uzbekistan, Mongolia, Russia and Belarus. Currently, we are implementing a very serious project together with Abbott Products Operations AG. The drug product “Physiotens", produced at our enterprise under the contract, will be delivered to Russia. The volume of deliveries will amount to 4.5 million packages, and with their account the share of exported products in the volume of production of our company will be 20%.

- In which direction will the company develop?

- In accordance with the investment plan, in the near future $ 50 million will be additionally invested in the development of the enterprise. New investments will be focused on the creation of the production of biological products and active pharmaceutical substances (APIs). Thus, not only generic, but also biotechnological import substitution will start to develop in the republic, and also for the first time in the history of our country a synthesis of pharmaceutical substances will be established.

Kazakhstan Pharmaceuticals is a real example of creating an entire industry, where large high-tech modern manufacturing enterprises have emerged and are successfully working, which in parallel with their development contribute to strengthening the country's economy, building human resources, and promoting pharmaceutical science and education.

Here everything is real and serious.