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Peter J. Werth, Chief Executive OfficerA leading full-service active pharmaceutical ingredient (API) development and supply company, ChemWerth provides current good manufacturing practices (cGMP) quality APIs to regulated markets for producing complex generic drugs.
“ChemWerth manufactures the active pharmaceutical ingredient that goes into the finished dosage our customers file for actual patient use,” says Peter J. Werth, CEO of ChemWerth.
With its extensive experience in custom synthesis and process optimization, ChemWerth addresses the increasing demand for complex and specialized APIs that are difficult to produce or not readily available in the market. This helps pharmaceutical companies develop their products, enter new markets, and stay ahead of competitors.
Its expertise in chemical synthesis, process development, and analytical testing ensures its products meet strict regulatory standards and are of consistent quality. This helps pharmaceutical companies streamline their production processes, reduce costs, and ensure patient safety. To guarantee that these high standards are met, ChemWerth assigns a chemist, an analyst, and a regulatory expert from its Shanghai office to each of its factories, along with other employees.
While an average DMF gets approved in about 25 months with two or three deficiencies, ChemWerth’s DMFs take about nine months to get approved with at most one deficiency. This is feasible due to its team’s experience, expertise in compliance and regulation, and the presence of former FDA workers. The regulatory expert assists in writing the DMF in accordance with FDA guidelines and obtaining approval. In addition, being familiar with the FDA’s deficiencies and having submitted DMFs in the past, ChemWerth knows what to modify in the DMFs.
ChemWerth ensures it abides by local rules and regulations while keeping the environment in mind. This helps address the growing concerns about environmental impact and the need for more sustainable manufacturing practices in the industry. In addition to its headquarters in Connecticut, ChemWerth has offices and manufacturing facilities in China and India.
ChemWerth manufactures the active pharmaceutical ingredient that goes into the finished dosage our customers file for actual patient use
With its state-of-the-art facilities and highly skilled team of experts, ChemWerth has established itself as a trusted partner for pharmaceutical companies worldwide. Its factories meet ICH Guidelines, are WHO-compliant, and USFDAapproved, guaranteeing the API is compliant, effective, and meets regulatory criteria in global markets. Its focus on difficult-tomanufacture compounds and expertise in process development and optimization make it an attractive partner for pharmaceutical companies seeking to bring drugs to market. The tagline, ‘First to Quality, Fast to Market,’ certainly justifies ChemWerth’s position in the pharmaceutical space.
Company
ChemWerth
Management
Peter J. Werth, Chief Executive Officer and Vincent Asaro, CFO; Patrick Lajoie, Marketing Specialist
Description
ChemWerth is a full service generic active pharmaceutical ingredient (API) development and supply company providing cGMP quality APIs to regulated markets worldwide.
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WOODBRIDGE - ChemWerth, a leading supplier of generic active pharmaceutical ingredients (APIs), announced today that company founder Peter J. Werth has stepped down as president and CEO to spend more time on his entrepreneurial ventures and many philanthropic efforts, effective immediately.
Widely recognized as one of the founding fathers of the generic pharmaceutical industry, Peter J. Werth founded ChemWerth in 1982 and led the company for 42 years. He will continue to serve as chairman of ChemWerth’s board of directors and will remain engaged in product selection and development.
Pete Werth III, who has been deeply involved in the company since its inception, succeeds his father as the new president of ChemWerth. Werth III has held several leadership positions over the years. He most recently served as a member of ChemWerth’s board of directors and was a senior advisor to the company.
“I am very proud to be able to continue building upon the strong foundation and reputation ChemWerth has established. Not only is my father an exceptional entrepreneur, but he is also a pioneer in the generic pharmaceutical market,” said Werth III. “I plan to continue to add value to our customers and look for innovative ways to compete in today’s generic pharmaceutical landscape.”
“After 40-plus years, the time was right for me to hand over the reins to the next generation. Pete has been working closely with me for many years, and I have the utmost confidence in his skills and experience to take ChemWerth to the next level,” said the elder Werth. “I would also like to express my gratitude to our employees, customers and manufacturing partners who have been part of our journey over the years.”
Under the direction of Werth III and the senior leadership team, ChemWerth aims to continue to grow its position as a global leader in the development and supply of generic APIs. In addition to its core generic API business, ChemWerth has begun leveraging its expertise to supply APIs for biosimilars and New Drug Applications.