Bachem is the world´s leading independent manufacturer of peptide active pharmaceutical ingredients (APIs) and a well established manufacturer of small molecules APIs. Each year, Bachem manufactures hundreds of batches of drug substance for projects in clinical trials and for products on the market.
Bachem is currently involved in more than 150 cGMP development projects targeting NCEs and Bachem offers a range of more than 30 generic drug substances. We have the capacity to produce peptide APIs from gram scale up to annual quantities of hundreds of kilograms and small molecules APIs from gram scale up to annual quantities of tens of tons. Our GMP manufacturing facilities are located in Switzerland and the United States and are regularly inspected by the FDA and local authorities.
In addition to more than 40 years of experience in the manufacture of drug substance, Bachem also has a strong regulatory background and we are well prepared to fully support you with the required regulatory documentation such as drug master files (DMFs). For complex development projects we support you with dedicated project teams comprising of our experts from R&D, production, quality control, quality assurance and regulatory affairs. A team of experienced Business Development Managers and Generics Managers look forward to working with you for your future requirements.