International Pharmaceutical Industry journal speaks with Recipharm about its global oral solid dose (OSD) manufacturing and development capabilities, exploring how the company is combining scale, technical breadth, and targeted investment to support an increasingly complex pharmaceutical landscape.
In this interview, Recipharm discusses its expanding footprint across key sites in Europe and India, its growing focus on high-potency APIs, and how ongoing investments in advanced technologies and infrastructure are enabling the company to meet rising demand for complex OSD products. The conversation also highlights evolving customer needs, key trends shaping dosage form development, and how geopolitical shifts are influencing outsourcing strategies within the global CDMO market.
Can you give us an overview of Recipharm OSD manufacturing and development capabilities?
Recipharm is one of the top leaders in the industry for oral solid dose. We have all the technologies and capabilities you would expect in the oral solid space, both in terms of scale and technologies, as well as breadth, meaning the number of sites.
We have a site in Leganes focusing on high potency oral solids. We have a site in Lisbon focusing on conventional oral solids, which includes capsules, tablets, beads and granules in all kinds of packaging such as sachets, blisters and bottles, as well as semi-solids and liquids. Our OSD site in Zwickau, Germany offers all conventional technologies and has expertise in bi-dosing and tri-dosing in hard capsules.
We also have a large site in Bengaluru, which is our flagship integrated development site for oral solids. This site has 1,100 employees and includes all capabilities such as capsules, tablets, dry and wet granulation and tableting. Integrated into this site is a large development team of around 60 people working on formulation development for oral solids, oral phases and related method development. We also have a large stand alone analytical team that can analyse everything. The development team is not only developing oral solids. They develop everything that you can put in your mouth and swallow, including solutions and suspensions.
Can you talk a little bit about the handling of highly potent APIs and the market dynamics around this area?
While the normal OSD market is growing at around 2 percent, the high potency market is expected to grow at 6 to 7 percent. This means that within the next seven to eight years, the market size for CDMOs is expected to double. The reason for this growth is that molecules are becoming more potent and are increasingly targeting serious diseases. Where you have an effect, you often have a side effect, and this market is therefore growing faster.
Our high-potency site in Leganes addresses this market growth and market needs offering manufacturing and packaging or high potent drugs. The key difference compared to normal manufacturing is the need for additional protection measures to protect people and to prevent cross-contamination. This is achieved through containment and full protection of operators, for example working behind plexiglass with gloves.
Looking at the clinical pipeline, there are currently more than 10,000 molecules, including generics, and it is expected that around 2,000 to 3,200 of these are high potency. This shows how strong the pipeline is. Based on this, we have decided to invest 5 million euros in our Leganes site to establish pilot-scale capabilities up to 10 kilograms. This allows us to support phase 3 and some phase 2 requirements, enable faster and cheaper tech transfer, and offer small batch manufacturing for orphan drugs. These investments are a direct consequence of market demand and technology needs.
What types of dosage forms or technologies are most in demand by customers today?
The majority of the pharmaceutical market, around 60 percent, is still based on tablets, capsules and granules. This is because they are cheap to manufacture, the supply chain is simple, no cold chain is needed, and administration is convenient.
The main dosage forms are tablets such as mini tablets, coated tablets, bilayer tablets or three layer tablets, as well as hard and soft capsules. In addition, there is a portion of granules used in stick packs or sachets, often to address swallowing difficulties. Around 40 percent of the population has difficulties swallowing tablets.
In the high potency space, the preferred dosage form is very often a hard capsule or a coated tablet. In many cases, the coating is applied simply to protect nurses, parents or children who are administering the medication. In high potency products, companies try to avoid wet technologies and organic solvents wherever possible. Ideally, the product is a dry blended or dry compacted powder that is filled into a capsule or compressed into a tablet, coated and released.
Can we talk about investments in infrastructure or technologies to support more complex OSD projects?
High potency is already complex, but beyond that we have made several recent investments. In addition to the 5 million euros currently invested in Leganes in pilot scale high potent manufacturing, we have invested around 3 million euros in a new development centre in Zwickau, Germany. This site focuses on dry technologies such as dry granulation using the Gerteis MiniPactor and compression and compaction simulation using the STYL’One tableting simulators. The development centre also has a four-punch tablet press and a capsule machine that supports dual dosing for fixed dose combinations.
Our next currently evaluated investment is in wet technologies, including coating and granulation with organic solvents, to address the modified release market. This would be another investment of around 5 million euros. The modified release market is large, fast-growing, and comparable in growth rate to high potency, even though it receives less attention.
We also have a site in Sweden where we manufacture one of the APIs on the WHO list of essential medicines. This is an integrated site covering API manufacturing, tableting, and packaging. Together with our partners, we are reinvesting in new infrastructure at this site, which represents a two-digit million euro investment.
In Bengaluru, we are preparing to establish a segregated area to comply with a new draft guideline on non-penicillin beta lactams. These molecules are in this case not antibiotics but show similar sensitisation potential and need to be treated like penicillin, requiring full segregation. This is a relevant market with several molecules affected, and we prefer to be prepared early.
In addition, we continuously invest in conventional technologies such as tablet presses and packaging lines. For example, we are currently investing in a new aluminium packaging line in Zwickau, representing around 2 to 3 million euros. Overall, with OSD revenues above 500 million euros per year, we reinvest a two digit percentage of our revenue back into the business, which is above the industry average.
How do you see the geopolitical environment influencing OSD manufacturing strategies?
There is a lot of discussion around manufacturing moving to the United States, with companies announcing major investments there. However, the overall investment budgets of these companies are not increasing. If more capital is invested in the US, less will be invested elsewhere.
We are present in the US, but we are the number one OSD provider in Europe. This is where we see our opportunity. If large pharma companies focus their investments on new facilities in the US and reduce investment in maintaining European facilities, we can step in as a partner. We already have the facilities, we are agile, and we are cost-competitive. This creates an opportunity for companies to outsource more of their OSD manufacturing to us in Europe.
For more information – https://www.recipharm.com/
