ChemWerth
Approved API Development to Simplify Drug Production

Generic drug development can be challenging, especially for medicines with complex active ingredients, formulations, dosage forms, or routes of administration. It is also difficult to obtain FDA approval, meet changing market demands, deal with supply chain disruptions, and compliance with environmental regulations. Having a partner to guide you through these challenges of development can be very beneficial and result in you getting to the market faster and having a significant competitive advantage.

A 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.

ChemWerth looks for products that are niche, difficult to develop chemically, or have other entrance obstacles, and produces them at its FDA-approved manufacturing facilities. The chemist executes their tasks, choosing the appropriate method, intermediates, and assisting in the production of the APIs. The analyst keeps track of the tests implemented, the methods used, and the project, ensuring the products are of high standards.

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 manufactures the active pharmaceutical ingredient that goes into the finished dosage our customers file for actual patient use

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.

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.