Press Room

Press Release / Sep 03, 2003

Hovione and CKD announce joint collaboration to produce and market Simvastatin

Hovione and CKD Bio Corporation (CKD Bio) have signed an agreement to produce and market simvastatin on a worldwide basis.

Hovione and CKD announce joint collaboration to produce and market Simvastatin1

Hovione and CKD Bio Corporation (CKD Bio) have signed an agreement to produce and market simvastatin on a worldwide basis. The joint collaboration will offer the active pharmaceutical ingredient (API) for simvastatin under cGMP to FDA and ICH requirements as well as the registration dossiers for simvastatin tablets for the European and United States markets. Both companies will be offering the product for sale only in countries where such does not represent an infringement of third party patent rights.

The collaboration guarantees an integrated supply chain for simvastatin – CKD Bio produces lovastatin that Hovione further transforms into simvastatin. Hovione has exclusive rights to use CKD Bio´s patented process (WO 01/45484 A2) for simvastatin manufacturing. The process validation batches of simvastatin (API) have been concluded, the filings will be ready in Spring 2003 and are suitable for worldwide registration.

The joint collaboration offers the market with probably the most competitive integrated manufacturing platform for the reliable supply of simvastatin API for the generic industry. CKD Bio has dedicated a portion of its fermentation capacity to the production of lovastatin. The new complete automated manufacturing building inaugurated in November 2001 in Macao by Hovione is dedicated to the synthesis of simvastatin. This integrated supply assures the generic industry with a reliable supply of simvastatin as well as a competitive price. The two Companies enjoy a long and fruitful business relationship, having collaborated in several projects involving semi-synthesis active ingredients over the last 30 years. The simvastatin project demonstrates the unique synergies, which the two companies benefit from. One with an unparalleled excellence in fermentation and the other with a long history of success in building synthetically on natural products and scaling the processes to industrial manufacture. This strategic integration puts Hovione and CKD Bio in a unique position to guarantee reliability of supply, competitive terms and complete customer support – for both API supply and/or final formulations including all registration requirements.

Simvastatin was developed by Merck and is currently marketed as Zocor®, by Merck & Co. and was the largest selling prescription drug in worldwide sales (USD 6.67bn) in 2001. The markets of United States, France, Germany, United Kingdom and Japan account for 58 tons of API annual consumption.

 

Hovione is an international Group dedicated to the process development and synthesis of APIs, serving exclusively the Pharma industry. With FDA inspected plants in Europe and Asia and a Technology Transfer Centre in New Jersey, Hovione is committed to the highest levels of service and quality. Hovione is a specialist in manufacturing difficult to make APIs and regulated intermediates under the most stringent controls of safety, quality and environmental protection. Hovione has more than 40 years of experience in chemical processes and, with 500 m3 of reactor capacity, has produced industrially more than 50 APIs.

CKD Bio is a Korean company established in 1941, with extensive research and production capabilities in the fermentation of active pharmaceutical ingredients. CKD Bio has a fermentation plant in Korea with a total fermentation capacity of 1.200m3. This plant is FDA inspected for several products. CKD Bio exports 30-40% of its production to the United States and Europe. CKD Bio has a division of Pharmaceutical Technology and New Drug Development of the Research Institute, located in Korea.

 

1 This announcement is not to be construed as a representation or as an offer to sell in those countries where such would constitute an infringement of third parties’ patent rights

Also in the Press Room

See All

The CDMO is preparing for its New Jersey facility to become fully operational this year. Hovione’s multimillion-dollar investment in expanding its East Windsor, NJ manufacturing site is quickly coming to fruition. Contract Pharma will be visiting the site later in April 2026 to provide a unique overview of what’s new. As a preview, the Contract Pharma team met with Hovione at the Drug, Chemical & Associated Technologies Association (DCAT) Week. David Basile, Vice President of Technical Operations—Americas, spoke at the opening Member Company Announcement Forum on March 23, 2026. In this interview, Basile expands on his remarks at the Announcement Forum. As he explains, Hovione is concentrating not only on New Jersey, but also on facilities in Ireland and Portugal. Contract Pharma: Good manufacturing practice (GMP) operations will soon be fully operational at the New Jersey facility. How has Hovione progressed through this process since the initial investment cycle was announced last fall—or even prior? David Basile: It’s been a really great journey and evolution over the last two to three years, conceiving the plan to grow our U.S. footprint. It was one of the reasons I came aboard with Hovione, to grow that footprint and build our commercial manufacturing prowess in the States. In New Jersey, we had originated [the site] as a tech transfer center. [But] we wanted to grow the organization to be more equivalent with our Portugal and Ireland sites, to do more large-scale manufacturing. So, this is part of that journey. And that’s not just bricks-and-mortar and machinery. It’s been people, talent, partnerships with clients, supporting functions such as QC [quality control] and analytical development. We’re growing our R&D teams as well. It’s a comprehensive approach to systems, people, and processes. CP: At the Member Company Announcement Forum, you ran through some of the major technical specifications of the NJ expansion. Can you talk about a few of the highlights and their capabilities? Basile: This year we’ll be starting up two PSD-3 scale spray dryers. This is a useful scale of machinery for our clients. It plays nicely between the PSD-2 and PSD-4 scales that we have elsewhere in the network. I’d say it’s medium-to-large scale capacity; we could do 30 metric tons annually out of this type of a unit. Product to product, that differs, but we do have products that put that kind of volume out in a PSD-3, so it’s not small-scale. Customers want to hear this because [they want to gain] efficiency with their batch size, and turnaround time. And when we campaign, we can really see significant throughput with this line up of new machinery and assets. The first machine that we will start up is a Hastelloy unit, which is unique. We took a pause [in the construction timeline] to make that upgrade, as we had a client that needed this configuration. There are additional clients that are interested in it too, because you can do acidic solutions and more aggressive kinds of formulations as well as solvent-based formulations. So that’s a unique element of that first machine. The second machine is being qualified later this year. Kind of a twin, but this one is standard 316 stainless steel.  CP: When a company brings a new or expanded facility online, new personnel often accompanies the new tech. What is the workforce addition that you expect, and what are the challenges of retaining top talent? Basile: In preparation for commissioning and startup of this new equipment, we’ve already ramped our headcount up, to be ready for GMP launch. We’ve added roughly 20 employees in preparation for this first machine to go [live]. Over the next 18-plus months, we could see something on a similar scale, getting us up to that 40–50 headcount range for that facility once it’s fully operational—and more later on in 2028, when we bring in the CDC [continuous direct compression] Flex unit. That’s what’s really going to be transformative about this new facility: that integrated offering coming to life. CP: Even if the NJ facility is top of mind right now, let’s also touch on some of your plans in Europe. What is your vision for expanding in Europe in the next two to three years? Basile: Ideally, Hovione’s aim is to build an equivalent manufacturing network, where clients can go to any site across the globe and get a similar breadth and scale of offering. We’re doing that now in Ireland, expanding our PSD-4 scale spray drying. One unit was recently installed. Late last year, it went live. Then there’s at least one other new PSD-4 in motion, which is really exciting, because [spray dryers] at this site were historically [exclusive to] larger chemistry manufacturing for API [active pharmaceutical ingredient] synthesis. So now, they’re further building their muscle with additional large scale spray drying capacity. On the Portugal side, there’s a lot of great things going on. Our Tejo campus, in Seixal, Portugal, is a massive, 4.5-million-square-foot plot of land, and there’s a new, modular facility going up there. It’s incredibly exciting. The design of the facility has been well-thought through with material flows [and] gravity-fed processes. Here, we minimize handling and [maximize] speed of processing. It’s scalable. We call each one of these building segments a finger. You can copy and paste these fingers, and they are built to house both spray drying and drug product assets within each unit. So, why is that relevant? Because we can easily scale the number of fingers. When customers say, “we need more capacity,” we have the design on the table ready to go. We know how to execute, we know how to build and implement our technology platforms in a short timeframe. Deployment timeframes are truly becoming more and more relevant to our clients. CP: From last year’s DCAT Week to this year’s, what conversations are you having with industry colleagues about ever-changing geopolitics? Basile: We’re seeing that local, regional manufacturing capacity is vital. The concept of U.S. for U.S. and China for China seems to be a common theme that our clients are talking about. We happen to have an edge, as we [have already] started our journey of expanding our domestic U.S. capacity. So I think that’s a crucial piece to the puzzle, having dual-sided Atlantic manufacturing operations. The traditional global supply chain model is being challenged. Having soup-to-nuts sites that are fully autonomous in development, scale-up, tech transfer, all the way to commercial scale operation, is vital to Hovione, and how we’re protecting our supply chain. [Concerning] starting raw materials and Tier 2 suppliers, our procurement teams are out in the market making sure that there’s no single point of failure for critical materials [like] polymers and solvents that we utilize. We’re managing and mitigating risk by looking at those secondary suppliers across different geographies. CP: Encapsulating your planned expansions on both sides of the Atlantic, how would you sum up the value to the customer? Basile: It’s about speed-to-market. It’s one partner from early-phase development, clinical scale, all the way through commercial. They gain comfort, trust, and not just capacity and equipment time; it’s also about competency and depth of scientific expertise. We’re not just a traditional CDMO. There’s unique expertise in particle science and spray dried dispersions that we offer our clients that they don’t have. [With] traditional CDMOs, customers typically pay for time in [a particular] unit, for example, they’d say: “I need a machine, and I need [it for] three weeks.” Hovione is truly a partner to our clients. They’re leveraging our platforms, our know-how in spray drying, and our know-how in equipment design. Read the article at ContractPharma.com  

Article
Contract Pharma, 6 April 2026

Hovione Eyeing Manufacturing Expansion on Both Sides of Atlantic

Apr 06, 2026

With key expansions coming to fruition on either side of the pond, specialist CDMO Hovione is making sure that drugmakers can access its particle engineering expertise across multiple geographies.  That flexibility will be key for the Portugal-based company in the coming years as the pharmaceutical industry continues to embrace more regional supply chains. In a recent interview, Hovione's David Basile, VP of technical operations for the Americas, discussed this trend and the manufacturer's expansion project, which is set to come online in New Jersey next month.  In the coming weeks, Hovione plans to debut a new spray drying expansion at its campus in East Windsor, New Jersey. The company has invested $100 million to expand its campus, including new construction and the acquisition of an additional facility and greenfield land.  Specifically, one of two pharmaceutical spray drying-3 units, or PSD-3 units, will come online in the coming weeks to tackle amorphous active pharmaceutical ingredients (APIs) and amorphous solid dispersions, according to the company. With some 80% of new small molecules in development insoluble in water, Hovione’s particle engineering and amorphous solid dispersion platform helps medicine developers improve the solubility, bioavailability, and, in some cases, the stability of their drug candidates, Basile said.  The company boasts spray dryers from the lab scale to PSD3 at its original facility in East Windsor, in addition to the pair of large-scale machines about to be activated at the campus' new facility.  “We’re going for a single, unified site with capabilities across the campus to do drug substance through finished drug product under one governance and quality system,” - Basile told Fierce.   Read the full article at FiercePharma.com

Article
Fierce Pharma, 26 March 2026

As expansions come online, CDMO Hovione aims to meet industry's 'dual supply and sourcing' zeal: exec

Mar 26, 2026

Twenty companies presented at the annual kickoff to DCAT Week. The Drug, Chemical & Associated Technologies Association (DCAT) opened DCAT Week 2026 with its Member Company Announcement Forum. The kickoff to the annual event in New York City, underway from March 23–26, 2026, showcased 20 companies. These were selected based on their announcements’ “news priority, criticality, and interest” to DCAT member companies. The following is a summary of highlights from the presentations, supplemented by additional information provided by some of the companies. (...) Hovione Hovione’s Vice President of Technical Operations for the Americas, David Basile, delivered the company’s Member Company Announcement Forum presentation. Basile will be speaking exclusively with Contract Pharma during DCAT Week, so check back for more on Hovione’s latest.   Read the full article at ContractPharma.com    

Press Clipping
Contract Pharma, 23 March 2026

DCAT Member Company Announcement Forum 2026: An Inside Look

Mar 23, 2026

Also in Events

See All