Dr. Ihab Kaldas
Interview with Viata Medicala Newspaper - Romania
SEDICO CCO & The Romania Market - Full Interview
We Are Not Just A Traditional Company Of Generic Medicines1. What is the purpose of your visit in Romania?
The key purpose is, to successfully find out the good Romanian partner that can further strengthen our existing presence in the Romanian market.
2. What makes Romania interesting to you (to your company)?
In fact, SEDICO has been already existing in Romanian market since 1997 by establishing its Romanian subsidiary SEDICO Impex SRL. in the year 2005 the operation was expanded by having Romanian staff as Med. Reps, Finance..etc., We do believe that some of our products portfolio are in great fit with the need & nature of the Romanian market.
3. Why should Romanian doctors be interested in SEDICO Pharmaceuticals?
SEDICO is a unique company with its Biotechnology products portfolio, in addition, its diverse of generics that needed by Romanian patients with of course affordable prices!
4. What types of pharmaceuticals do you plan on bringing to Romania?
Some essential food supplement products are already existing, in addition; we are aiming to introduce Biotechnology products too i.e. Insulin and Erythropoietin.
5. Do you have bio-equivalency studies for your generic products? For which ones?
Yes we have Bio-equivalence studies for oral solid preparations according ICH guidelines.
6. Does Egypt have a drug authority, an agency like FDA in the US? If so, what is the jurisdiction of this institution, how does it work? How do you collaborate with them? Does this authority also regulate food supplements?
Yes we have the Egyptian FDA called CAPA that regulates from the early beginning of file submission till granting Marketing authorization (clinical trials, post market survey,...etc.) They also regulate the food supplements, as you asked.
We at SEDICO must collaborate, however, they are in our opinion tough institute!
7. What was the impact of the Egyptian revolution on the pharmaceutical market in the country? How did your company experience this process? How did it affect the physicians, as well as the patients?
At the beginning, it has been some negative impacts on the company and all other stakeholders, but this was general effect on all companies in Egypt. Since the correction made by the second revolution in June 30 th. 2013, things are progressing positively in a way to reach political & economical stability.
8. Will SEDICO also get involved in public sector tenders?
In Egypt, SEDICO is a leading company in public sector tenders and we are aiming to participate in this important sector in Romania in the near future through our direct participation or through our future partner in Romania.
Worth mentioning that in countries like Egypt & Romania, the public sector is and should play an important role in the health care system due to the economical status.
9. What role does biotechnology play in your company? Do you plan on exporting biotechnology products to Romania?
As early said, biotechnology products are very strategic to our company and we are expanding our portfolio for example :Insulin, Follicular Stimulating Hormones (FSH), Growth hormone (Somatropin), Human granulocyte colony stimulating factor (Filgrastim) & Erythropoietin (Epoetin), and we are currently exporting some of those products to Middle East, Africa & recently to some key Asian countries, we are also planning to introduce our biotechnology products to Romania.
10. I know SEDICO has been the first company in Egypt to produce insulin, What drove a local company to make this decision? Was there a shortage of insulin in your country? What challenges did the company face? Can you please describe the process? Does the company have clinical and bio-equivalence studies for the SEDICO insulin?
As you may know, since the start of SEDICO in 1986, "Organon" the Dutch multinational pharmaceutical company was one of the shareholders investors with almost 23% shares. Organon was the first company in the world to discover Insulin in the year 1923 and this of course was one of the motives that make SEDICO produce Insulin by having the API from Organon-Diosynth.
In addition; Insulin is always a critical products in most of the countries like Egypt & Romania and there are a very few multinational players who are more or less controlling the global market of Insulin, also should consider that Diabetes as disease is booming everywhere in the Globe. this is briefly why we have decided to produce Insulin.
We do have successful clinical trials & bio-equivalent studies of Insulin and as mention before we are already exporting to other countries.
11. What do you think health professionals in Romania should know about SEDICO?
In our opinion; they should perceive SEDICO as growing Biopharmaceuticals that add values to their patients with really affordable prices, and is not a traditional generic company; SEDICO is also considered one of the biggest production facilities in the MENA (Middle East and Northern Africa) region.
12. Are you looking to hire people from Romania, either in the medical representatives staff or on your research projects?
We have had already an office in Bucharest "Frumoasa street, was operated by Romanians till 2013 called ” SEDICO Impex” including medical representatives, administrator, finance & legal staff.
We do hope that we will be able to be strongly back to Romanian market by having more registered products as well as Romanian staff in the very near future.