About Us
A Leader in High Quality Generic APIs.
21st Century economic, social, technical and regulatory dynamics are dramatically changing the pharmaceutical world making it more challenging than ever to find profitable opportunities. That’s why it’s important to work with a supply-partner who knows how to navigate through the tough issues, help you overcome obstacles and get you to the market fast to gain a competitive advantage.
ChemWerth is that supply-partner!
Established in 1982
ChemWerth is a full service generic drug development and supply company providing high quality Active Pharmaceutical Ingredients to regulated markets worldwide.
Through exclusive development and partnerships with API manufacturers, ChemWerth provides expertise in product selection & development; analytical and regulatory services and strong project management to ensure the highest standards of quality.
Our knowledgeable, responsive pharmaceutical professionals are committed to providing our customers with a distinct competitive advantage. Our team of technical, analytical, regulatory and marketing experts can enhance your business by:
Advancing your product development and saving time in the ANDA approval process.
Collaborating with manufacturers in establishing appropriate protocols & methodologies to prepare a sound and complete Drug Master File (DMF).
Sourcing APIs from China, India, Germany & the US to provide our customers with the best value.
Advancing your Paragraph IV filings through our exclusive API development and supply partnerships.
Mission Statement
Continue to build on over 40 years of success as the leading supplier of reliable, high-quality, non-infringing active pharmaceutical ingredients at competitive prices and superior technical/regulatory support services.
Continue virtual development of ANDA’s with selected marketing partners by leveraging our knowledge and relationships in the industry.
To be widely recognized in the industry as a valued leader and resource in developing and training manufacturers of active pharmaceutical ingredients to become successful cGMP compliant and FDA approved ChemWerth sources.
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New Product Development
Where our FDA approved laboratory begins developing products, formulating and validating methods to ensure quality.
Compliance Audits
Where we audit and champion our partner factories to exceed cGMP standards set by authorities.
Regulatory Services
Where all submissions are filed with the knowledge and experience of our 550+ worldwide approvals on record.