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
The contract development and
manufacturing organization (CDMO) sector witnessed significant activity in the
first quarter (Q1) of 2025, characterized by strategic investments, facility
expansions, and collaborative partnerships.The quarter saw some
significant deals. WuXi Biologics agreed
to sell its vaccine manufacturing facility in Dundalk, Ireland, to Merck for € 500 million (US$ 521 million). Quadria Capital announced the acquisition of a 10 percent
stake in Aragen for US$ 100 million. This investment will help Aragen
accelerate its research and development efforts.Some CDMOs, like India-based Syngene International and Belgium-based Ardena expanded
their presence in the US market. Syngene completed
the acquisition of its first US biologics facility that it had purchased from Emergent Manufacturing Operations Baltimore
for US$ 36.5 million. And, leading
nanomedicine developer Ardena purchased a drug manufacturing unit in New Jersey from Catalent. View CDMO Activity Tracker for Q1 2025 (Free Excel Available) Axplora expands its ADC
capacities; Quotient Sciences wraps up HPAPI unit upgradeThe antibody-drug conjugate
(ADC) market saw considerable investments by CDMOs. Axplora expanded its commercial payload production capabilities at its Le Mans site in France, reinforcing its position as a leading player in ADC manufacturing. This expansion is part of the France 2030 program and builds on Axplora’s track record of supplying 40 percent of the world’s marketed ADCs and 50 percent of ADCs approved by the US Food and Drug Administration (FDA).Samsung Biologics said
it will support a series of LigaChem Biosciences’ ADC programs at its new dedicated ADC facility. Similarly, Cerbios-Pharma announced significant enhancements to its ADC production capabilities. Cerbios also announced the
expansion of its high potency active pharmaceutical ingredients (HPAPIs)
production capabilities. On March 31, Cerbios-Pharma got acquired by Healthcare Advanced Synthesis, a leading developer of APIs, HPAPIs and anticancer compounds. Both these global players are based in Switzerland. Overall, HPAPIs saw
significant investments.
Quotient Sciences made headlines with the successful completion of a US$ 1.4 million project
designed to improve high potency handling capabilities at its Philadelphia (US) facility. The initiative focused on upgrading infrastructure and implementing advanced safety protocols to manage HPAPIs more effectively.Polfa Tarchomin achieved significant
milestones in enhancing its pharmaceutical manufacturing capabilities. The
company successfully completed the site acceptance test (SAT) for its vial filling and packaging line
at the Center for Development and Production of Highly Potent Drugs, ensuring
full functionality and compliance with good manufacturing practice (GMP)
standards.Additionally, Polfa Tarchomin is installing a high-tech, high-containment robotic
ONCO LINE designed for aseptic production of highly potent pharmaceutical
products, including lyophilisates and liquid formulations in vials and
pre-filled syringes. Developed in collaboration with leading global suppliers,
this line supports multiple packaging formats and comes with advanced systems.
With an annual production capacity of up to 6 million units, this line will set
a new benchmark in pharmaceutical manufacturing.In a significant development
for analytical testing, SK Pharmteco launched an enhanced
laboratory specifically designed for HPAPIs. The new facility is in California
(US). View CDMO Activity Tracker for Q1 2025 (Free Excel Available) Evonik expands RNA portfolio; Catalent to support Galapagos’ CAR-T therapy trialsThe success of mRNA vaccines
and the growing interest in RNA therapeutics is luring CDMOs to rapidly expand
their capabilities in this emerging area. Evonik, in collaboration with ST Pharm, announced plans to
expand its portfolio of RNA and nucleic acid therapeutic services during Q1.
The partnership enables Evonik to provide customized nucleic acids from ST
Pharm alongside its portfolio of lipid and lipid nanoparticle (LNP) drug
product development services.ReciBioPharm secured a grant from the Bill & Melinda Gates Foundation to advance RNA manufacturing technologies that meet FDA standards
with a focus on improving access to RNA therapeutics in low- and middle-income
countries.The cell and gene therapy
sector also witnessed remarkable activity in Q1 2025. Catalent announced it will support Galapagos’ decentralized CAR T therapy trials for GLPG5101 for relapsed/refractory non-Hodgkin lymphoma
indications.Similarly, AGC Biologics announced it will manufacture and supply
lentiviral vectors for Adaptimmune’s solid tumor cell
therapy initiatives. And, Genenta and AGC Biologics
strengthened their cell therapy manufacturing pact through a collaboration agreement. This grants Genenta access to
the exclusive GMP suite at the AGC Biologics Cell and Gene Center of Excellence
in Milan, dedicated to manufacturing cell therapy products. View CDMO Activity Tracker for Q1 2025 (Free Excel Available) EUROAPI, StrainChem join
hands to develop peptides; Fermion expands flow chemistry capabilitiesEven traditional therapeutics like peptides and small molecules
saw considerable investments by CDMOs. For instance, EUROAPI and StrainChem announced a collaborative venture to develop liquid
phase peptides. The partnership aims to harness advanced synthesis techniques and innovative technologies for more efficient peptide manufacturing. Through this collaboration, EUROAPI and StrainChem will offer their customers a one-stop shop solution for peptides. In one of the most ambitious
expansions announced this quarter, CordenPharma unveiled plans to
invest over € 1 billion (US$ 1.10 billion) over the next three years in building and expanding small, medium, and large peptide manufacturing facilities across Europe and the US. That includes a new greenfield facility for peptide manufacturing in the Basel region of Switzerland, valued at over € 500 million (US$ 553 million).In obesity treatments, Viking Therapeutics agreed
to pay US$ 150 million to CordenPharma for the production of its dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) agonist VK2735.In a show of confidence, Indian
CDMO Neuland Labs’ board approved a ₹ 3.42 billion (approximately US$ 42
million) capital expenditure plan. The approved capex is earmarked for enhancing the company’s peptide synthesizer reactor capacity and building additional capacity to meet growing demand.In the small molecule space, Fermion announced a strategic investment to expand its flow chemistry
capabilities, aiming to enhance processes and sustainability by integrating
continuous flow techniques into manufacturing. This technology offers advantages in scalability,
process control, and safety, positioning Fermion at the forefront of
pharmaceutical innovation.Recipharm announced a major expansion of its aseptic
filling capabilities, encompassing process development, pilot-scale production,
and clinical supply operations. Similarly, Curia announced significant expansions to its global network of sterile fill-finish sites, aiming to enhance production capacity, streamline supply chains, and improve overall quality in sterile pharmaceutical manufacturing. View CDMO Activity Tracker for Q1 2025 (Free Excel Available) Our viewDuring Q1 2025, the CDMO sector continued to evolve towards higher-value and more complex services. This only underscores the crucial role CDMOs are playing in supporting growth and innovation in the pharmaceutical industry.With the Trump administration
in the US triggering a global tariff war, drugmakers have no option but to reshape their supply chains. And this means more business for CDMOs that manufacture
drugs in the US. In the coming quarter, we expect strong dealmaking and
increased focus on innovation in the CDMO sector.
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