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
Ever since Donald Trump has moved into the White House for a second term, there has been turmoil across the world. One of the issues that has been of concern is ‘tariffs’. Trump is keen to reduce United States’ trade deficit through import tariffs.Since the mid-1990s, the US has been importing drugs from across the world largely tariff-free, and its drug imports have risen consistently. In 2024, the US imported US$ 213 billion worth of medicines, which was more than two and a half times the total of its drug imports ten years back.Until recently, it seemed like the administration would spare the
pharmaceutical sector. But at a fundraiser dinner held for the Republican Party last week, Trump said: “We're going to be
announcing very shortly a major tariff on pharmaceuticals”. The
pharma tariffs, he said, would be “at a level that you haven’t really seen before”.The US is the largest consumer of pharmaceuticals globally, accounting for 45
percent of global sales. Given the nature of the global pharma industry, ‘major tariffs’ would have far-reaching impact. PharmaCompass
studies the likely impact of tariffs on drug
imports into the US, and whether they would serve the purpose they
intend to.Cost of import tariffs, setting up domestic capacities
will be borne by US consumersThe Trump administration has two key objectives
behind implementing drug import tariffs.
One, it wants to secure US drug supply chains by onshoring
drug production. Two, it wants to create more manufacturing jobs in the US. Will tariffs be successful in achieving these objectives?Importers generally pay the tax and pass it on
to the consumer. Bernstein analyst Courtney Breen estimates that in the
worst-case scenario, tariffs could result in an extra US$ 53 billion in costs paid for pharmaceutical imports. According to economist Ernie
Tedeschi, “costs for prescription drugs
would rise by an average of around US$ 600 per year per household” in the US. Not all of that would be ‘out-of-pocket’, and families may “end up paying higher insurance premiums [and] higher co-pays”.Many drugmakers may want to avoid that cost, and shift manufacturing to the US. Though American drugmakers Eli Lilly and Johnson & Johnson have
announced mega investments in the US, it’s difficult to say if other
drugmakers will find it viable to set up capacities. Having
said that, just this week Novartis
announced a US$ 23 billion investment in the
US.Overall, resources
are expensive in the US. Due to heavy reliance on imports, the country does not
have industrial plants needed for large-scale production. Factors like labor regulations, high cost of living, mandatory benefits etc, have made the workforce quite expensive. It’s puzzling how any drugmaker will overcome these challenges and create manufacturing jobs. Even if they do, the high costs of manufacturing will translate into costlier drugs.According to a recent report undertaken
by RAND, prescription drug prices in
the US are on an average 2.78 times those seen in 33 other nations. With
tariffs, that gap will widen further.Drug supply chains are complex; moving capacities to
US costly, time-consumingAccording to the US Food and Drug Administration (FDA), as of August
2019, only 28 percent of the facilities producing APIs for the US market were
located domestically. The remaining 72 percent were overseas, with nearly half
of its generics coming from India.The US is also highly dependent on drug imports for critical therapies. In 2024, the European Union supplied US$ 127 billion worth of high-value branded medicines to the US.The pharmaceutical supply chain is complex. There are a series of chemical steps involved in making any drug, with each step often being performed in different locations.The supply chain is determined by a variety of factors, such as
availability of cheap labour, tax rates, supply of raw materials etc. For
instance, Ireland has a very low corporate tax rate. Therefore, it has emerged as a hub for the production of APIs used in blockbuster medicines, such as Lilly’s Zepbound and Merck’s Keytruda.Moving production to the US will take five to seven years per plant.
Each plant will cost US$ 2 billion or more. And it will have to go through several checks to meet America’s high regulatory standards. It is a long, arduous and unnecessary exercise, when
capacities, expertise and cheaper labor is already existing in other countries.Europe also plans to onshore, leading
to turbulent shift in trade dynamicsLike the US, Europe
too is heavily reliant on China
and India, and is working towards reducing its
dependence. Over the
years, Europe has moved significant resources into the US, especially in R&D. American drugmakers like Pfizer and Johnson & Johnson, on the other hand, manufacture many of their drugs in Europe and export them back to the US. Tariffs, therefore, will impact European exports
in a big way. Drugmakers confronted
European Commission President Ursula von der
Leyen soon after Trump spoke about the pharma tariffs. These drugmakers, led by Novo Nordisk’s CEO Lars Fruergaard Jørgensen, asked for a “rapid, radical policy change” so that R&D and manufacturing doesn’t get directed towards the US.According to these drugmakers, up to 85 per cent
of capital investments (about €50.6 billion, or US$ 56 billion) and up to 50 per cent of R&D expenditures (about €52.6 billion or US$ 58 billion) are potentially at risk. These figures
are taken from a total of €164.8 billion (US$ 182 billion) worth
of pharmaceutical investment planned
in the EU during 2025
to 2029.Tariffs will test low margins of
generics, may put a pause on dealmakingTariffs will have a different impact on generics. According to a Brookings
report, while tariffs will “provide a strong incentive for increasing US manufacturing of brand-name drugs”, it will not be incentive enough for older, off-patent generic drugs, which “represent over 90 percent of the volume but only a small share of spending”.It will be difficult for generic drugmakers to onshore due to high
capital expenditures and low and uncertain returns on investment. In fact,
tariff pressure will test the wafer-thin margins of generic drugmakers in both
the US and overseas. This could lead to product discontinuations or drastic
cost cutting, which in turn could erode product quality.In the end, as Arthur Wong, senior director of corporate ratings, healthcare, at S&P Global Ratings, puts it, all this
chaos is going to “put a pause [on] or distract” from another key pharma function: dealmaking. The time for executing M&As was now. But we can’t expect dealmaking to return until the second half of 2025.
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