«NOBEL AFF» increases the export of drug products

"NOBEL AFF" increases the export of drug products

The capacity of the Kazakhstan pharmaceutical market is not so great. Therefore, the most important direction of business development is the export of products for local drug manufacturers. This makes it possible to expand production, transfer new technologies and develop new products. Ms. Svetlana Kil, a managing director of NOBEL AFF, tells how Kazakhstan pharmaceutical manufacturers are moving in this direction today.

- Svetlana Valeriyevna, in which countries are NOBEL AFF products supplied to today?

- At present, we supply our products to Russia, Kyrgyzstan, Uzbekistan, Mongolia and Belarus. The share of exported products in the volume of production of our company is gradually increasing. It should be borne in mind that the delivery of drug products to a foreign market is not an easy process. Their circulation is strictly regulated in all countries. One cannot simply start importing and selling pharmaceutical products. First, marketing study is done, the structure of morbidity and drug consumption is studied, as well as legislation in the field of drug regulation. We need to clearly understand what are the requirements for their production. Then there is a state registration of the drug product conducted, under which a comprehensive assessment and expertise of its effectiveness, safety and quality is carried out. In addition, the regulatory authorities of the country in which the drug product is registered are required to go to the site for inspection. Thus, they assess the compliance of the manufactuing conditions with the requirements of Good Manufacturing Practice (GMP) and give their own opinion. Only after successful completion of all these procedures a Marketing Authorization is issued, and we can begin the delivery of goods. As a rule, the process of preparation and registration takes several years and requires considerable financial costs.

Nevertheless, export makes it possible to develop the production and assortment portfolio, because the release of some drugs without expanding the market is generally unreasonable. Since this may require the installation of a new line or even the construction of a separate department.

- Tell us in more detail how the company develops exports to Russia.

- This is a very attractive market and, above all, in terms of the volume of drug consumption. Of course, many pharmaceutical companies, including Kazakhstan, seek to organize the delivery of their products to this country. Nobel AFF JSC is not an exception. Since 2015, together with the transinational pharmaceutical company Abbott Products Operations AG, we are implementing a very serious and interesting project. According to the agreement of contract manufacturing, the production of the original drug of Abbott Products Operations AG “Phyziotens® (Moxonidine)” was set up in two dosages – 0.2 mg and 0.4 mg at the site of Nobel AFF JSC. This is a third-generation hypotensive drug that is used in the treatment of arterial hypertension.

I note that the launch of the production of the drug was preceded by several inspection audits by Abbott Products Operations AG itself, which confirmed the compliance of the manufacturing conditions at our site with GMP standards.

In 2015, we started supplying this drug for the needs of the statutory free medical assistance in the Republic of Kazakhstan and after a successful launch, began to consider the possibility of expanding cooperation. As a result, we decided to manufacture the drug Physiotens® for the Russian market.

In the 4th quarter of 2018, the first batch of the original drug Physiotens® was produced for the Russian market, and in November of this year we began to ship finished products to this country. It should be noted that in Russia it will be implemented not only in the segment of public procurement, but also in the retail market, i.e. through pharmacies directly to the consumer.

- What does this project give the company "NOBEL AFF"?

- Firstly, the transfer of technology was carried out for its implementation, and that is very important for the development of production. Secondly, we have the opportunity to learn from the experience of international companies, both in terms of production and in terms of implementing transnational projects.

Today it is the only such project in Kazakhstan. Its importance is very high, since the placement of the production of original products of international companies in a domestic enterprise speaks about the competence of staff and the compliance of production capacities with the international requirements.

- Svetlana, tell me whether this project received support from the government?

- Of course, the export volume is an important criterion by which the company's contribution to the country's economy is estimated. Therefore, the state is trying to stimulate the orientation of enterprises for export. Speaking specifically about this project, it is being implemented with the support of the Government of the Republic of Kazakhstan, the Ministry of Health of the Republic of Kazakhstan and the National Company KAZAKH INVEST JSC.

A few days later, all Kazakhstanis will celebrate the Independence Day of the Republic of Kazakhstan. Taking this opportunity, on behalf of NOBEL AFF, I congratulate the citizens of our country on this important national holiday!

With all my heart I want to wish every family health, prosperity and well-being!