Founded in 1942, Lannett Company, Inc., has an extensive history of manufacturing various pharmaceutical medicines, including over 100 currently distributed products. Perhaps lesser well-known, the Trevose, PA-based company is a long-established contract development and manufacturing organization (CDMO) specialized in oral solid dosages and liquids, including high potency and DEA controlled substances.

The company’s manufacturing facility sits on approximately 30 acres and includes production space of roughly 224,000 square feet and 204,000 square feet of warehousing and distribution space. This translates to a manufacturing capacity of 3.5 billion oral solid doses and 2 million liters of liquids per year.

The CDMO business makes up almost 10% of the value of the organization as well as the volume of the plant that produces its partners’ products.

Recently, the company expanded its liquid drug manufacturing capabilities when it received FDA approval to manufacture Numbrino at its Seymour, IN, plant, allowing the site to rapidly expand liquid drug manufacturing.

Contract Pharma had the chance to talk with Lannett’s CEO, Timothy C. Crew, about the company’s initiative to strengthen its position as a CDMO—backed by a long reputation for being a very reliable, high-quality supplier of affordable generic medicines and partner services.

Contract Pharma: What led you to your leadership role as chief executive of Lannett?

Timothy Crew: I started my career working with U.S.-based firms, including the U.S. Army and Bristol Myers Squibb, but have spent most of my career working with globally based firms, largely in the generic sector. About five years ago, some colleagues I knew on both the board and the team at Lannett shared with me an opportunity and requested that I join them. For me, it was a chance to come home to a great team focused on the USA, perhaps literally and figuratively given, I was living in Florida at the time but had spent most of my working career living in the Philadelphia area where Lannett is based.

CP: Can you provide some background about the company and its position as both a generic drug maker as well as a provider of CDMO services?

Crew: Lannett has been around for a very long time. It is one of the oldest operating generic company in the U.S. dating back to the 1940s. We’re smaller, so not as well-known as some of the bigger players. We provide roughly 1% of the U.S. drug supply on volume, and we sell about 100 pharmaceutical products—half of which have been launched in the last five years or so.

In addition, while we’ve been around a long-time providing our own generic medicines, Lannett has also provided CDMO services for partners for decades, specializing in oral solid dosages and liquids, including high potency and DEA controlled substances.

CP: How has Lannett’s CDMO business evolved in recent years?

Crew: First, we’ve implemented a strategy to really step up our CDMO efforts—to get our name out there and let the industry know we are here as a provider of CDMO services. While we’ve been offering CDMO services for decades, we are now actively placing our CDMO organization front and center, whereas this wasn’t the case in the past. We are getting the word out about our capabilities as a reliable and affordable provider of high-quality products, which is more challenging than people sometimes might think. So again, putting our CDMO business front and center has been a major initiative for us.

CP: What are some company highlights from the past 12 months?

Crew: From a portfolio perspective we have been migrating from offering so-called commodity products, to medicines and services that are both more affordable for patients and of higher market value. For example, we are progressing a portfolio of valuable respiratory and insulin products. There’s obviously lots of conversations on the national front these days about the affordability of insulins and similar types of medicines. We are proud to be a part of those conversations and next year hope to be part of a meaningful solution on affordable insulin.

On the operating front we recently consolidated our network and completed the liquid drug build-out at our Seymour plant. We received FDA approval well ahead of schedule, demonstrating our team’s capabilities, dedication, and focus. Moreover, it further opens the door for expansion of our contract development and manufacturing efforts we market to other companies into the solution and suspension categories.

CP: What are your customers’ key concerns when partnering on projects?

Crew: Customers want their products delivered on time and on budget. They also want to work with a team that is capable, experienced, and easy to work with. It’s also important to keep in mind that things change in our environment on a regular basis, so being adaptable is key.

As I noted a few moments ago, half of our portfolio was launched in the last five years, which required a lot of adaptability to make it happen. We take great pride in our team’s experience and bring that attitude of professional flexibility to the table. In fact, we sometimes like to think of ourselves as willing to jump on loose balls, and that energy, that commitment, that excitement about what we do is something that I think our partners also appreciate.

CP: What are some of the key trends impacting CDMOs and services in general?

Crew: Well, it’s still a fairly fragmented space, and I do think that sometimes matching up supply from the CDMO side and demand from the partner side is easier said than done. Typically, partnerships have a long gestation period. Very early on you need to make decisions about trusting your partner with something incredibly important, and you don’t quite know what will emerge from that entirely. There are some larger CDMOs out there with a lot of technologies in those plants, but sometimes finding space in those plants with a highly engaged partner can be a challenge.

Building the foundation of trust between a partner and a supplier is also something we focus on. And it’s why, again, we think it’s more important than ever for Lannett to be more visible in terms of showcasing the kinds of products and services we offer, and the quality we deliver—we believe a lot of partners could benefit from our CDMO skillsets.

CP: What are your goals for Lannett in the years ahead?

Crew: Well, whether it’s the CDMO business or our core medicines operation, keeping costs down, keeping customers and partners happy, and keeping our pipeline projects progressing to patients is essential to our success. It sounds easy but it’s not. And we’ve got a team working very hard to make that happen.

For our CDMO efforts specifically, we think there’s a real opportunity to step in with reliable, high-quality supply right here in the U.S. with Lannett’s team of experts across various technologies in the oral solid dose space, including, modified technologies, complex formulations, high potency products, and seamless scale-up from pilot- to commercial-scale.

CP: Is there anything else you’d like Contract Pharma’s readers to know?

Crew: Reliability, quality and adaptability as it relates to the supply chain is a hallmark of Lannett. We’ve been in this business for a very long time and our delivery records are far higher than the average firm out there. I think our success starts with a commitment to quality—fostering a culture of quality by doing the right things right. This was demonstrated during the successful FDA inspection of our Seymour plant last fall. We continue to operate under a VAI status when many of the top manufacturers out there, on the generic side at least, have had more significant FDA observations. So, we’re proud of our record and know that our customers can rely upon us.

Ultimately, we want people to know Lannett is here, and we can help. We’ve been around for a long time. We’re easy to reach. We’re in the right time zone. We’ve got a great, experienced team supporting both our medicines and CDMO businesses, with a decades long record of successful partnerships in the industry. But don’t take my word for it, please give our team a call, ask for references and hear what our long-term partners have to say.

Learn more about Lannett Company here