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/ 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
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