This week, SpeakPharma interviews Pete Werth III, the new president of ChemWerth, a company that has been at the forefront of the generic pharmaceutical industry for over four decades.
He shares his vision for ChemWerth, which includes his commitment to strengthening global manufacturing relationships, and enhancing supply chain resilience. Additionally, he highlights the key aspects of a successful drug master file (DMF).
HIGHLIGHTS// Pete Werth III, the new president of ChemWerth/ vision for ChemWerth/ commitment to strengthening global manufacturing relationships/ key aspects of a successful drug master file
Your father,
Peter J. Werth, is recognized as one of the founders of the generic
pharmaceutical industry, having built ChemWerth from the ground up over four
decades ago. How do you view his legacy? As you take the helm, what key lessons
or principles from his leadership do you intend to carry forward?
My father, Peter J. Werth, is a true pioneer in the generic pharmaceutical industry. Over his 42‐year tenure, he not only built ChemWerth from a humble garage startup into a global leader in generic API development but also established standards that many in our industry now take for granted. Under his leadership, we filed our very first DMF in 1987 and have since achieved more than 500 DMF filings. With an average review cycle of just 0.79, we have been far outperforming the industry average of 2.5 cycles.
His focus on quality, regulatory excellence, and a relentless commitment to customers’ success set the foundation for our reputation as a trusted supplier of over 500 APIs sourced from more than 30 cGMP-certified facilities worldwide. Equally inspiring is his dedication to nurture long-term, mutually beneficial relationships with manufacturing partners across the US, Europe, India, and China, as well as his passion for giving back to the community through philanthropic initiatives.
As I take the helm, I intend to build on his guiding principles — sustaining our high standards of quality and compliance while pursuing innovation in regulatory strategy, diversifying our supply chain, and embracing new technologies and approaches to remain competitive in an evolving market.
I will also strive to continue his legacy of
mentorship, ensuring that our company culture remains rooted in integrity and
diligence, with an unyielding focus on making safe, affordable medicines
available worldwide.
HIGHLIGHTS// trusted supplier of over 500 APIs/ 30 cGMP-certified facilities worldwide/ embracing new technologies and approaches to remain competitive
What are your top
priorities as the new president of ChemWerth? How do you plan to strengthen and
expand relationships with manufacturers worldwide?
My immediate priorities as the new president are
twofold: to enhance the value we deliver to our customers and, to deepen our
relationships with our manufacturing partners worldwide.
We will further diversify our supply chain and
broaden our product portfolio. Our expansion plans include upgrading equipment,
and hiring additional highly skilled scientists, engineers, and GMP auditors.
We will also leverage our proprietary product
selection and regulatory submission processes. These processes help us get the
regulatory filing right the first time, and allows us to be approved 44 percent
faster than the industry average. This helps our customers gain a competitive
edge in the market.
In essence, by strengthening operational excellence and expanding our global network, we intend to continue the company’s long-standing commitment to customer success and process innovation.
We plan to reinforce our long-standing relationships with our manufacturers — especially those in strategic markets like China and India — by helping our partners meet the highest standards of regulatory compliance and current good manufacturing practice (cGMP) quality. This balanced approach of strengthening existing partnerships while pioneering new ones is key to maintaining and growing our competitive edge.
HIGHLIGHTS// diversify our supply chain and broaden our product portfolio/ commitment to customer success and process innovation/ filings approved 44 percent faster than the industry average
When ChemWerth
last spoke to PharmaCompass, there
was a mention of investing millions of dollars in expanding manufacturing partnerships in China and India. Can you elaborate on the success of these partnerships, and how have they contributed to ChemWerth’s overall growth?
Our strategic, multimillion-dollar investments in manufacturing partnerships are a cornerstone of our growth strategy. Over the past few years, these joint ventures have proven their worth by diversifying our supply base and mitigating the risk of global supply chain disruptions — a lesson that became all too clear during the Covid-19 pandemic.
These investments are already paying dividends.
They help us support manufacturers producing steroids, hormones, veterinary
products, and large-volume APIs, while also accelerating the development of
small-molecule inhibitors and new generic APIs.
We have ensured that our partners are equipped
with the latest equipment and trained personnel to meet cGMP standards. By
partnering with facilities in these markets, we now have access to
state-of-the-art production capabilities that enable us to produce a wider
range of APIs at competitive costs.
The success of these partnerships is evident in our ability to consistently file DMFs rapidly — often on the first cycle — and deliver affordable, high-quality medicines to patients worldwide. This supports our clients’ growth trajectory and has helped us expand into new markets.
This strategy has reinforced our global footprint — supporting our presence in 38 countries with over 100 products — and positioned us well to capitalize on a global generic drug market projected to grow at a compounded annual growth rate of 5.4 percent from 2022 to 2030, to reach a size of US$ 671 billion by 2030.
HIGHLIGHTS// strategic multimillion-dollar investments/ support manufacturers producing steroid, hormone, veterinary products/ development of small-molecule inhibitors and new generic APIs/ ensured partners are equipped with the latest equipment and trained personnel
ChemWerth has an impressive track record, and an over 40-year relationship with the US Food and Drug Administration (FDA). What are the key aspects of a successful DMF? Are there specific challenges manufacturers face in preparing DMFs, and how does ChemWerth help them overcome these hurdles?
ChemWerth’s record of filing over 500 DMFs in 38 countries reflects our commitment to excellence in regulatory compliance and quality management. A successful DMF is built on comprehensive documentation that rigorously follows cGMP guidelines, robust analytical validation, and detailed tracking of every step.
Every DMF we file meticulously details the entire manufacturing process — from raw material acquisition to final batch production. This comprehensive approach ensures that our submissions meet the rigorous quality, safety, and efficacy standards expected by the FDA.
Our team stays continuously updated on the
evolving guidelines and protocols, which allows us to file DMFs that align with
current FDA practices. We recognize that many manufacturers face challenges
such as complex regulatory requirements, lengthy review cycles, and the need
for precise coordination between various production stages. ChemWerth helps
them overcome these hurdles by offering end-to-end regulatory support, detailed
internal audits, and continuous training on cGMP and FDA requirements.
Our efficiency is a critical competitive
advantage. By receiving approvals 44 percent
faster than the industry average, we help our customers get their products to
market faster, resulting in larger market share and increased profits.
HIGHLIGHTS// over 500 DMFs in 38 countries/ robust analytical validation/ end-to-end regulatory support
What is your
vision for ChemWerth over the next few years? How do you plan to navigate the
challenges and opportunities in the generic pharmaceutical industry?
I plan to continue to add value for our customers, and look for innovative ways to compete in today’s generic pharmaceutical landscape.
At ChemWerth, our vision for the future is rooted
in both our proud legacy and our relentless drive for innovation. We will
further diversify our supply chain and expand our product portfolio. We have
begun leveraging our expertise to supply APIs for biosimilars and new drug
applications (NDAs), while maintaining our reputation for rapid regulatory
approvals.
With unwavering determination, we uphold our “First to Quality. Fast to Market.” approach — delivering high-quality APIs to customers worldwide while leveraging our expertise to give them a competitive edge in their markets.
HIGHLIGHTS// supply APIs for biosimilars and NDAs/ give customers a competitive edge in their markets
In 2024, Big Pharma players consolidated
and maintained their dominance, even as innovation continued to reshape the
pharmaceutical landscape. The primary change last year was the meteoric rise of
glucagon-like peptide-1 (GLP-1) receptor agonists that treat diabetes and help
in weight loss.Amongst drugmakers, Pfizer retained its numero uno spot
with an impressive US$ 63.6 billion in prescription drug sales
(up 7 percent from US$ 59.56
billion reported in 2023), despite ever-shrinking Comirnaty sales, which
settled at US$ 5.35 billion in 2024 (from US$ 11.22 billion in 2023).Merck secured the second position
with revenues of US$ 57.4 billion, a growth of 7 percent over 2023. This performance was predominantly fueled by Keytruda, which now accounts for more than half of Merck’s total pharmaceutical revenue. Johnson & Johnson came a close third with US$ 57 billion in prescription drug sales
(up from US$ 54.76 billion in 2023).AbbVie held the fourth position with US$ 56.33 billion in sales, achieving 3.7 percent growth despite the ongoing erosion of Humira revenue. This flagship immunology drug saw sales plummet 37.6 percent to approximately US$ 9 billion, a US$ 5.4 billion reduction compared to 2023. Humira’s loss was offset by AbbVie’s newer immunology assets, particularly Skyrizi and Rinvoq, both of which demonstrated exceptional growth trajectories. View Our Interactive Dashboard on Top Drugs in 2024 by Sales (Free Excel Available)European giants Astra, Roche,
Novartis, Sanofi round out top 10 list; Novo, Lilly see astounding growthWhile the top four positions were dominated by American drugmakers, European giants dominated the lower half of the top 10 list.AstraZeneca secured the fifth spot with US$ 54.1 billion in sales, thereby posting impressive growth of 18.1 percent over 2023. Roche claimed the sixth position
with US$ 50.9 billion in sales while Novartis ranked seventh — with sales of US$ 50.3 billion. Novartis' impressive 10.8 percent sales growth is attributed to its
innovative medicines portfolio. Oncology therapies remained a cornerstone for
both these Swiss drugmakers.Bristol Myers Squibb (BMS) secured eighth
position with revenues of US$ 48.3 billion, representing 7.3 percent
growth over the previous year. At US$ 45 billion, Eli Lilly posted 32 percent revenue growth last year. Its GLP-1 drug Mounjaro helped Lilly move up from the tenth in 2023 to the ninth spot last year.Sanofi landed the tenth position
with US$ 42.6 billion in sales, propelled largely
by the expanding indications of Dupixent. The French multinational has
increasingly focused on this immunology blockbuster, while also garnering more
sales from its vaccine and rare disease portfolios.Novo Nordisk merits a mention as it
posted an incredible 26 percent year-on-year growth. It retained its eleventh
spot with US$ 40.25 billion in sales. Novo’s growth was driven almost exclusively by the extraordinary success of its GLP-1 receptor agonist portfolio. View Our Interactive Dashboard on Top Drugs in 2024 by Sales (Free Excel Available) Merck’s Keytruda retains throne with US$ 29.5 bn in sales, as Novo’s semaglutide nips at its heelsMoving on to drugs, Merck’s Keytruda (pembrolizumab) solidified its position as the world’s top-selling pharmaceutical product with sales exceeding US$ 29.5 billion and year-on-year growth of
17.88 percent (US$ 4.5 billion). This remarkable performance was driven by
steady sales growth across more than 40 indications in the US. In 2024 alone,
Keytruda secured four new approvals from the US Food and Drug Administration
(FDA).However, Novo Nordisk’s semaglutide sales (Ozempic, Wegovy and
Rybelsus) gave Keytruda a run for its money. Across the three blockbuster
drugs, semaglutide earned the Danish drugmaker around US$ 28 billion — i.e. a year-on-year increase of 38 percent.Novo’s Ozempic (semaglutide) reached over US$ 16.7 billion in sales — a 26 percent increase from 2023. Originally approved in 2017 to improve glycemic control, Ozempic bagged additional approvals in 2020, and in January 2025. It is now approved to reduce the risk of major cardiovascular events, as well as to reduce cardiovascular risk and to lower the likelihood of chronic kidney disease in type 2 diabetes patients.Sales of Wegovy (semaglutide), the other blockbuster GLP-1 drug
from Novo, grew by a whopping 85.7 percent to over US$ 8 billion.Sanofi and Regeneron’s Dupixent (dupilumab) secured the number three spot with sales of US$ 13.6 billion, representing an impressive 22.4 percent
year-on-year growth. In 2024, Dupixent received three new approvals and one
label update. Notably, it became the first-ever biologic medicine approved for
patients with chronic obstructive pulmonary disease (COPD). View Our Interactive Dashboard on Top Drugs in 2024 by Sales (Free Excel Available) AbbVie’s post-Humira strategy pays off as Skyrizi surges 51%; Lilly’s Mounjaro posts 124% growthGilead Sciences’ HIV treatment Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) showed robust growth of
13.27 percent, touching sales of US$ 13.42 billion in 2024 and emerging as the
fourth largest selling drug. Biktarvy now commands over 50 percent of the US HIV treatment
market. Unlike many other drugs on this list, Biktarvy faces no immediate
patent challenges, with key protections expected to remain intact until 2033.BMS and Pfizer’s anticoagulant Eliquis (apixaban) claimed the fifth position
with US$ 13.33 billion in sales, representing a 9.21 percent year-on-year increase. AbbVie’s Skyrizi (risankizumab)
emerged as one of the fastest-growing assets with a 50.95 percent year-on-year
increase, generating US$ 11.71 billion in 2024 sales, thereby surpassing Humira’s (adalimumab) diminished sales.This impressive performance, combined with Rinvoq’s (upadacitinib) growth, has prompted AbbVie to raise its long-term outlook for these products. The
company now expects combined Skyrizi and Rinvoq revenues to exceed US$ 31
billion by 2027, with Skyrizi alone projected to generate over US$ 20 billion.Johnson & Johnson’s Darzalex (daratumumab) claimed the seventh position with US$ 11.67 billion in sales, representing 19.77 percent growth over 2023.Lilly’s Mounjaro (tirzepatide) demonstrated dramatic
growth with sales increasing 123.51 percent to US$ 11.54 billion. This performance was complemented by Zepbound (tirzepatide, for weight loss), which contributed US$ 4.9 billion to Lilly’s revenue. By the end of 2024, Mounjaro received FDA approval for a new indication in
obstructive sleep apnea (OSA), becoming the first and only prescription
medicine for moderate-to-severe OSA in adults with obesity.Stelara (ustekinumab) ranked ninth, bringing J&J sales of US$ 10.36 billion, showing a modest decline of 4.91 percent from its 2023 sales.Vertex’s triple-combination therapy Trikafta (elexacaftor/tezacaftor/ivacaftor) for
treating cystic fibrosis rounded out the top ten list with sales of US$ 10.2 billion, up 14 percent from the previous
year. View Our Interactive Dashboard on Top Drugs in 2024 by Sales (Free Excel Available) Our viewIn 2024, transformative therapies like GLP-1 receptor agonists drove growth in the pharmaceutical industry. This year, we expect GLP-1 drugs to dethrone Keytruda from the number one spot. Along with novel immunology agents, we expect GLP-1 drugs to realign the pharmaceutical market.
Share
