™Medicine∫ Category at the 9th Chemistry R&D Project Market Event
Vildan Kumrulu, Vice Chairman of Polifarma, said, “We developed Turkey’s the first domestic 3-chamber parenteral nutrition solution together with our colleagues at our PolAr-Ge. After receiving our EU GMP Certificate, we will start exporting this product to Europe.”
Could you inform us about the foundation story of Polifarma?
The organization story of Polifarma Pharmaceuticals underlies the love of Turkey. In 1979, our founder and my beloved wife, the late Pharmacist Necdet Kumrulu, started his business life by establishing Memleketim Pharmacy in Ordu. Then he moved to Istanbul and founded Aroma İlaç in 1983, saying “Serum is a must for the hospital, why is a Turkish brand not dominating this market”. He purchased Polifarma Pharmaceuticals in 1986 and lays the foundations of today. We succeeded in realizing the dreams of the founder Necdet Kumrulu in 2016 as the market leader in the field of serum.
Today, we have an annual production capacity of 350 million boxes and the ability to manufacturing products in both Glass/PVC, PP, vials, ampoules (lyophilized and liquid), PFS forms at the same time in our production facility located on an area of 77 thousand square meters in Ergene, Tekirdağ. We have 466 licensed products in all forms in 11 different therapeutic areas. Quality is one of the most important issues for us. We work with great passion to offer the best quality of life to the society with the products that we produce with the highest health standards and environmentally friendly. We supply raw materials of our products from EU GMP certified suppliers. In raw material supply, we act in accordance with FDA raw material standards. We currently export brands to 46 different countries. We are the most preferred brand of Turkey in the field of hospital drugs and serum.
When was your R&D Center established? Could you give information about your work related to PolAr-Ge?
We are an R&D center approved by the Ministry of Industry. Founded in 2017 our PolAr-Ge, is currently working with a team of approximately 50 people in an area of 2000 m2. Since the beginning of 2019, we gave weight to the study will be the first generic product in Turkey and the World. In this context, we focused only on the synthesis of molecules that global companies are active ingredient producers but do not sell to other companies.
We are working on adding innovative dosage forms to existing forms. In these studies, by using the advantage of our production technology for pharmaceuticals in tablet form around the world, we continue our work for product development in parenteral / injectable solution or drinkable solution forms and the production of drugs that are imported into our country and / or that will be brought to our country in the coming years, even though they are abroad.
We are a company that invests entirely with our equity capital, without any incentives and support. We know, companies that do not make enough R&D investments do not have a very long-life span. Investing companies can take an advantageous position in the short term. For this, we have an R&D unit that attaches importance to market dynamics. According to the data of 2019, we are among the top 15 companies that invest in R&D most, we foresee that we will be among the top 10 companies for 2020.
What about your recent works in the field of R&D?
We were deemed worthy of first place in the “Medicine” category with our R&D study of “Development of the Stable Oral Solution Form of Favipiravir with High Efficiency Against Coronavirus for the First Time in the World” at the 9th Chemistry R&D Project Market Event organized by Istanbul Chemicals and Chemical Products Exporters’ Association (IKMIB) with the approval of the T.R. Ministry of Trade. Aroma İlaç, operating under Polifarma Pharmaceuticals, manufactured the product in the form of oral solution, which is the first in the world for the treatment of Covid-19. Aroma İlaç, cooperating with TÜBİTAK for this study, produced two different treatment cures with the oral solution form as well as the tablet form of Favipiravir. Both advanced a mild case of both the drug can be used in both Turkey and the world was made patent applications, while the permitting process continues.
Using our knowledge and technology, we developed Covid-19 products in injectable and drinkable form for patients who have respiratory problems, tablet swallowing difficulties, intubated in order to alleviate the difficulties of using medications.
Some of these products are the first form developed in the world. We made our patent application in order to protect our intellectual rights and interests.
In the Covid-19 pandemic, the demand for our products has increased rapidly. In this process, we were proud to deliver our products to European countries such as England, France and Spain. We responded to additional scientific studies and reports from the health ministries of these countries with fast actions. These demands are a reflection of the trust in our company, our production facility equipped with the latest technology and our products.
Do you have any export products from your R&D studies?
We produced Turkey’s first domestic 3-chamber parenteral nutrition solution together with our colleagues in our PolAr-Ge. Our product successfully passed all 10 separate tests determined by the American Drug and Food Administration (FDA) as the quality standard for lipid finished products. Our Turkey’s first domestic three-bedroom parenteral nutrition solution product is used for intensive care, postoperative and patients who cannot be fed orally. We export to the Middle East and Africa regions. After receiving our EU GMP Certificate, we will start exporting this product to Europe.
In addition, we continue our studies on drug active ingredient synthesis and molecule discovery with Japan, which leads the global pharmaceutical industry. In this context, we signed contracts for 2 molecules in Japan. Clinical trials are ongoing.
Are there any firsts you achieved?
As Polifarma Pharmaceuticals, with 100 percent domestic capital, we have achieved many firsts with the experience of our 34-year history in the field of IV (intravenously) and serum drug. We developed the Turkey’s first lipid product, first IV NK-1 blocker, the first domestic 3-chamber parenteral nutrition solution and Automatic SAPD Device, which is the first and only product in the world for safe and easy dialysis at home. With this device, we were awarded with “Non-Medicine Innovation” Award 2019 at the Golden Mortar Awards, known as the Oscars of the Drug. We also received “Parametric Release” approval which is not in any pharmaceutical companies in Turkey. In addition, our business is continuing in association with Turkey’s leading research institutions and universities. We have a project partnership with TÜBİTAK in the development processes of nearly 15 drugs that are imported by global companies and cost over 2 billion TL to the state.
What are your goals?
We will make the FDA application for our projects, which we will start in 2021, in 2022. With these projects, we want to represent the level our country has reached in the pharmaceutical industry in the best way possible. Our short-term goal is growing in international markets by increasing our branded exports to 46 countries.
