Tipperary company sits among the giants of the Irish pharmaceutical sector

The Irish pharmaceutical sector is home to some of the world’s largest companies and most recognisable brands - companies such as GlaxoSmithKline, Johnson & Johnson (J&J), Merck, Abbott, Astra Zeneca and Eli Lilly.

And while perhaps not a name that springs immediately to mind, we have, located on our own doorstep in Cashel, a company that now rightly sits among such giants of this life-essential business sector – Amneal Pharmaceuticals.

Founded in 2002 by brothers Chirag and Chintu Patel - Indian immigrants to the United States in the 80s – Amneal now has 15 sites across the world. Six in the US, eight in India and one in Ireland (Cashel). These sites are responsible for a multitude of functions including Research and Development, Production, Packaging, Sales and Distribution. The company employs over 7,500 people globally and is the developer and producer of more than 270 generic, specialty, biosimilar and injectable pharmaceutical products.

And Amneal Ireland, located on the Cahir Road site occupied until the end of 2011 by J&J, is just about to reach a major landmark in the company’s history; in the middle of this year the Cashel plant expects to transition from being a research and development function to a fully operational commercial entity. It is a truly exciting and motivational time for all at the Cashel operations and great news for the town of Cashel, the county of Tipperary and its people.
It is an impressive story of rebirth, regeneration, success and joy.

I am at the site to meet with Niall Prendergast, Vice President of Operations and Site Head for Amneal Ireland.
Originally from Crecora in Limerick but a resident of Killenaule since 1999 with his wife Eleanor and children Sean (21) and Anna (19), Niall is a pharmaceutical industry veteran with over 30 years’ experience in senior engineering and operations roles. Amneal’s hugely positive and impressive developments in Cashel are also particularly poignant for him, as he was previously part of the leadership team in 2011 that was given the responsibility to move J&J’s operations away from Cashel and to close the site down. At that time, he, too, was to lose his job as part of those developments. But more of that later.
I ask Niall about the journey to commercial operations and the importance to the company.

CASHEL SITE BOUGHT BY AMNEAL IN 2015
“The site was bought by Amneal at the end of 2015 to design and manufacture generic inhalation products which, at that time, was a new product area for the company, a whole new business stream. One product platform is a metered dose inhaler and another a dry powder inhaler for the US market for customers such as the larger pharmacy chains, hospitals and clinics. They will be branded as Amneal, our own labelled product for the US market.
At the moment all the products are in the latter development stage, and our first products for commercial use are undergoing review towards approval by the US Food and Drug Administration (FDA).
Our submissions for these products were made in 2022 and at the beginning of 2023 and we expect to start commercial production in earnest in the middle of this year upon FDA approval.
At the moment we have 90 people on site and are currently recruiting another 20 plus. We’ll then be ramping up and hiring another 50 or so people as we get ready for commercial manufacturing and launch toward the middle of the year
The majority of staff are Tipperary based - Cashel, Clonmel, Cahir, and Thurles, but we do have some from Limerick, Kilkenny, Cork, Waterford and the Portlaoise areas.”

And what originally brought you to Tipperary that led to your journeys with J&J and Amneal?
“I was an Electronics Engineering graduate from the University of Limerick, and my first jobs were in engineering and automation for water treatment plants for county councils and chemical reactor control systems for big chemical plants in Cork.
Myself - and my wife to be at that time - were looking at where we wanted to locate ourselves and we had veered towards Tipperary – my wife is from Killenaule - and a good opportunity came up with Merck Sharp and Dohme (MSD) in Ballydine in 1997.
I spent six years there and in 2002 this site in Cashel had been acquired by J&J and was being designed and constructed and in early 2003 the opportunity came up for me to take the role as Lead Process Engineer for the plant and I joined in that role. At the end of 2003 the Director of Engineering position was offered to me. I was involved in starting up this plant, ramping up the operations, adding a significant expansion from 2007-2009, and then shutting it down at the end of 2011!”
I ask Niall about the closure of the plant in 2011. As a local myself, I remember very well the closure and its impact upon people and the area. It was major news and a talking point at the time and a worrying time for the area. I asked Niall what happened at that time to cause the closure?

“It was a combination of factors, not least being timing and a strategy to change products at the site. Older products had been transferred out and new products were being transferred in. However, a design issue arose with the new product platform which meant that the product would not be launched. So, the site ended up in a situation with no product to manufacture which led on to a company decision to close in late 2010.
It took about a year to close the plant down. The closure was announced at the end of 2010 when there was a very tight jobs market. We used 2011 to decommission the whole plant and to run an outsourcing support programme for all the employees to help them find alternative employment.

The site was then empty from the end of 2011 up until the end of 2015 when Amneal bought it.”
How did Niall reflect career wise and life wise on that journey? Having been with J&J and having a leadership role in closing the business down and in the process, making himself redundant? And now being here with Amneal, and not just seeing the business and its people grow but being the lead for the site as it approaches such a landmark moment with commercial operations imminent? I receive an immediate, forthright, and powerful reply.

“For me J&J was a very positive experience. They were a good company and a good employer with good products. They gave me many opportunities from a career perspective and great experience over nine plus years.
While the ending probably wasn’t what we wanted, if I look back, I think that as a company J&J supported the site and its leadership team with everything, we needed to support the workforce with programmes to help seek and secure alternative employment. While it is never a nice decision it is how you behave and how you support the people through that process that is most important.

MANAGEMENT AND LEADERSHIP
Such events give you a huge amount of experience – not in the technical space but in the management and leadership space. It also provides you with an extra motivation when you go into future roles that you never want to end up in such a situation again. To be able to draw on the experience of the circumstances that led up to it and the experience of managing people through a very turbulent time in their own working lives, it gives you life experience and motivation going forward.
I was on the redundancy list also. We all were and I was one of the last ones out of the door.”
And how did you arrive back at the site for Part Two of your Cashel journey?
“After J&J, I moved to Sanofi, the Biotechnology group based in Waterford, and held Director roles in Engineering and Operations. It was a plant where we produced oral dose tablets and injectables for rare diseases such as enzyme deficiency diseases, enzyme replacement therapies – all very specialised medicines. I was there for eleven years.
In mid-2022 I was approached by Amneal about the role here. The eleven years I was at Sanofi I was still located in Killenaule so this was an opportunity to get back more local. But, importantly, to get back to a site that I had such fond memories of even though I had to go through the process of closing it down. We had a great group of people here.
Anytime I’d drive through Cashel and see the empty site I’d think what a shame it was to see the empty facility. So, when the opportunity came up it was a great opportunity for me to be part of giving the site a second lease of life. I started with Amneal in October 2022.
It was hugely attractive to have a leadership role in creating new opportunities for people who live around the area.

AMBITION TO BUILD SOMETHING SPECIAL
I have such a strong ambition to help build something special on this site again and create an outlet for people to become part of the journey”
I asked Niall what he was particularly proud of in this story of growth and what now is the main challenge as Amneal Ireland approaches a commercial reality.
“We had the FDA on site in November last year to do their pre-approval inspection. When they are formally reviewing a product for approval they will come and do an audit of the manufacturing site to make sure that you are able to operate to the standards that they require for supply into the US market. We had a full week audit with zero observations by the FDA - there was not even one minor observation for improvement to be made. You can’t get any better than that! This was a great and true reflection on our people and the work they do here.

The challenge now is that we need to start to get ready to ramp up to a much different environment. One which is a continuous production environment, a commercial supply environment. It is a journey we need to go through but everyone sees the importance of becoming commercial and starting to become a revenue generator for the company
Our complete focus is on delivering complete reliability of supply and a competitive cost of goods.”
Our conversation moves onto his family, life in Tipperary, his community and sport.
Niall has been the treasurer of Killenaule GAA club for the past eight years and is the newly appointed treasurer of St. Rita’s Camogie club in Fethard. He is also involved with Killenaule - Moyglass ladies soccer club, all of which takes up several nights a week
Checking my notes and a quick bit of arithmetic allows me to conclude that Niall has been living in Tipperary longer than he lived in his native Limerick and – given his personal investments in sports in his communities – I ask him would it be fair to say that he was both a proud Tipperary man and a proud Limerick man.
“I suppose that’s fair enough” he says with a chuckle. “With the whole background of the GAA, it is all about club roots and it is all about community roots. It is my community and I am proud to be involved with the clubs in it. If Limerick aren’t involved in a game I’d always be shouting for Tipp.

THREE TIPPERARY JERSEYS AND A LIMERICK ONE
Both my children, like my wife, were born in Tipperary and both are currently studying at The University of Limerick to become secondary school teachers. They are huge Tipperary fans. When there is a Tipperary/Limerick match on there is one Limerick jersey and three Tipperary jerseys going out the door……that has always been the way.”
In our interview, Niall spoke about Amneal’s mission “to make healthy possible” and provide broader access to more affordable essential medicines. That resonated with me and I left the meeting with Niall with a great sense of optimism and pride. Optimism for the positive impact Amneal can have on Cashel and Tipperary as it becomes a global commercial entity and pride that the town is the host to such a story of recovery and growth and that products designed and manufactured in the town will soon be enhancing and saving lives.

This article was published in The Nationalist as part of a series called Doing Business In Tipperary by Martin O'Connor (pictured above).