🔒Woodbridge pharma company ChemWerth eyes overseas expansion

Acting as a broker between foreign manufacturers and U.S. drug companies, Woodbridge-based ChemWerth has grown from one man working in his garage into a multimillion-dollar international company.

ChemWerth recently announced expanded partnerships with factories in China and India and new multimillion-dollar investments in makers of key drug ingredients.

The company, which is marking 40 years in business in 2023, plans to bolster its stake in factories making steroid, hormone and veterinary products, along with small-molecule inhibitors like aspirin and allergy drugs, according to CEO Peter Werth.

Privately held, ChemWerth has revenues in the $50 million to $75 million range, according to Dave Moore, chief strategic officer. The company plans to hire scientists, engineers and manufacturing personnel worldwide in coming months as part of its expansion plans.

It has carved out a niche in the global generic drug development and supply industry by focusing on active pharmaceutical ingredients, or APIs. Those active chemicals are combined with other ingredients by drug companies to make dosages of popular drugs.

ChemWerth partners with global API manufacturers, offering services and consultation related to product selection and development, analytical and regulatory issues and project management. That includes helping overseas manufacturers develop drug ingredients and ensuring that their products comply with U.S. safety and effectiveness rules.

The global generic market is projected to grow to $671 billion by 2030 from $439 billion in 2022, with an annual growth rate of 5.4% over that period, according to Precedence Research.

“ChemWerth is a generic pharmaceutical company specializing in the development of active pharmaceutical ingredients,” Moore said. “With those contract manufacturers, we supply or provide the regulatory and the compliance assistance to make sure that the drugs are safe and that they have efficacy, and that they will be Food and Drug Administration (FDA) approved.”

ChemWerth employs 30 people in Woodbridge in offices at 1764 Litchfield Turnpike. Another 25 work in Shanghai, China, and two people are based in Hyderabad, India.

Many employees specialize in the regulatory and compliance needs of pharma companies and have experience working with the FDA, allowing ChemWerth to routinely earn approval on its first pass, according to the company.

ChemWerth employees work with manufacturers to track and document the active pharmaceutical ingredients-making process from start to finish, and also keep in contact with companies that formulate the drugs to ensure consistency and accuracy in the end product.

Increasingly, the company is also creating new products for the pharma marketplace.

“We’re full service — we provide not only the regulatory support but new product ideas and then finally, logistics and customer service,” Moore said.

From garage to boardroom

ChemWerth got its start in 1983 in the garage of Peter Werth, a Stanford-trained chemist with an interest in the potential of generic drugs. He was among the first to explore pharmaceutical manufacturing in China, and traveled there to develop relationships with factories.

Werth’s business plan was super-charged in 1984, with the passage of the federal Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Act, which eased rules around the use of generics in the U.S. pharmaceuticals industry.

Since then, ChemWerth has steadily grown at about 7% a year, with employee headcount increasing by 5% a year.

“We’ve never had a layoff in the history of the company. We don’t borrow money. We’re 100% financially secure,” Moore said.

ChemWerth now sells more than 100 products and does business in 35 countries. Over its history, the company has filed more than 500 drug master files, or submissions to the FDA relating to pharma manufacturing products.

The company has also weathered recent crises like the COVID-19 pandemic by anticipating supply-chain disruption, Moore said. U.S. drugmakers were urged to order their raw materials in advance as the pandemic intensified, avoiding shortages.

Going forward, ChemWerth’s expansion in India and China makes sense in the longer term, as both countries continue to grow as pharmaceutical markets and manufacturing centers. Adding new products is also a priority.

“We have diversified both our product portfolio and our manufacturing portfolio,” Moore said.

Cancer drugs are a growing part of the product mix, along with veterinary drugs used for pets like cats and dogs.

“We see a lot of opportunity in the animal health space,” he said.

Giving back to higher ed

As his company has prospered, Peter Werth has used his wealth to benefit local universities.

Werth pledged $22.5 million to UConn in 2017 to create the Werth Institute for Entrepreneurship and Innovation, the second-largest such gift in university history. The institute brings together programs intended to spark startups founded by students and faculty.

Werth also pledged $1 million in 2021 to establish the Werth Entrepreneurship and Innovation Center at Bridgeport’s Housatonic Community College, the largest gift in the school’s history.

The family’s foundation has also funded the Werth Center for Coastal and Marine Studies at Southern Connecticut State University.

Other beneficiaries include the Massaro Community Farm, Monroe Playground Foundation and Werth College of Science, Technology and Mathematics at Fort Hays State University in Kansas.

“He’s very much about giving back,” Moore said of Werth, adding that salaries at ChemWerth are at the top of the range for the industry. “We worked hard to build the business. [Werth] has made a good living, and he gives back to employees and to the community at large.”