It’s been a long time from our previous meeting. Could you give us a quick overview of your product range? what is new since our last meeting, what is still the most requested?
Mandy Rehlnder (M.R.): Indeed it has been some time since our last meeting and since then we have seen many movements in the market. HARKE Pharma is a pan-European specialist for excipients used in solid dosage forms. Very recently, we added Sodium Stearyl Fumarate to our portfolio as we see more and more customers who would like to use alternatives to Magnesium stearate to increase the stability and overcome the risk of over-lubrication. Our most requested product range remains Hypromellose and other Cellulose derivatives from Shin-Etsu since our customers value the technical expertise, constant availability and outstanding quality of these excipients. We experienced good growth here, also due to the low level of Nitrosamines in Shin-Etsu’s excipients.
Being an expert in the field of excipients, could you give us an overview of today’s trend among the products?
M.R.: We have seen many trends in the last months. I already mentioned Cellulose derivatives connected to the low level of Nitrosamines, but also HPMC as agent for sustained release applications in nutraceuticals and pharmaceuticals is gaining market space. In addition, we see that the requirements for low levels of Nitrites and Nitrates apply to further excipients, such as MCC or SMCC. For our range of Povidones, Copovidones and Crospovidones, we could achieve a healthy growth of market share due to shortages in the market caused by the established manufacturers. HARKE has been collaborating with the leading Chinese manufacturer Boai NKY since 2018. As Boai NKY offers superb quality from a state-of-the-art and back-integrated manufacturing facility, our customers take benefit from good availability and a complete documentation facilitating the qualification of our material as additional excipient source. Actually, we visited Boai NKY end of May 2023 to celebrate the 20th anniversary and the opening of an additional plant, which will further secure the availability of our PVPs. On the other hand, we have seen an increasing demand for alternatives to Titanium dioxide, replacement of Silicon dioxide and the need for Talc, which is tested on every batch for asbestos content.
How do these trends influence the Pharmacopeia requirements? From your point of view, what is missing from the regulatory side?
M.R.: This is a good question. For the time being, we do not see an immediate impact on the Pharmacopeia. However, the industry starts requesting for analytical proof of low Nitrosamine levels and I feel that once a compendial method has been developed, we will see several product monographs requiring batch testing regarding Nitrosamines. This will take a couple of years but we see that the industry is preparing for this and spending a lot of effort to increase he patient safety. We as HARKE Pharma are working with our suppliers to provide as much support as possible to our customers on his topic and we keep monitoring the developments of the pharmaceutical standards.
How do you help to manage your client’s bottleneck of the supply chain?
M.R.: Our team is very proud to say that we could prevent delivery delays in the past months. This is possible due to our storage capabilities in Germany. Since we are a family-owned business with a long-term vision, we prefer to work with own capital, which decreased our dependency on the developments of interest rates, which are nowadays increasing and therefore make stock financing more expensive. As a distributor, we always have to keep the balance between availability and shelf life of the material. Therefore our sales teams are in close contact with our customers to understand their forecasts for a decent stock planning.
What is the key factor of being a successful distributor?
M.R.: I am convinced that the success of a company in connected to passionate employees who act responsibly. Our teams are passionate about understanding our customer’s challenges and work together on solutions whilst on the other hand we strive to work closely with our suppliers in order to be ahead of the trends. HARKE has been known for several decades to be a technologically driven distributor, meaning that we perform on-site trainings, support customers in formulation design in order to reduce the amount of trials and be quicker to the market. This service does not only apply to the big players or to large countries, we care about every customer. In addition, we consider universities and machines manufacturers as close business partner who support us understanding our excipients better and who work with us to innovate pharmaceutical technology and formulations.
Where developers could find an inspiration?
M.R.: There are many sources for inspiration in pharmaceuticals. I would say the most established ones are exhibitions, such as CPhI or scientific conferences such as the PBP WorldMeeting. Our team also gains a lot of knowledge from scientific article and magazines. This is why we have been working with PharmEquip Journal for a long time already. Furthermore, I think online seminars are becoming an important source for inspiration and knowledge transfer nowadays. There fore we have established HARKE Academy, an online platform accessible via www.harke.com, with on-demand content discussing various technological topics.
Where our readers could meet you?
M.R.: The next occasion to meet our technical and commercial experts will be CPhI in Barcelona. HARKE will exhibit at booth 4H21 to showcase our portfolio of raw materials & solutions for Pharma and Nutra. We invite everyone who wants to learn more about us or who would like to discuss their current challenges with our experts to visit our booth. Our team is also available for individual on-site visits and your readers are always welcome to come and see us in our headquarter office in Germany.
Thanks for sharing with your experience and knowledge. See you soon!
