Heumann’s API business stands on three legs: API’s for the generic market, custom-manufacturing of lifecycle-end products for big pharma and NCE’s. The business is successful based on Heumann’s strengths in process development and customer service. For most of the API’s manufactured, Heumann has developed independent, proprietary processes which yield highest quality products and which are characterized by high volume yields, environmental compatibility, and the avoidance of waste and dangerous reagents. The current reaction portfolio covers more than 50 reactions in organic chemistry and every year 30 to 35 products are manufactured in a range from 10 kg to tens of tons. With the new Chem III facility Heumann offers manufacture of the final stages of the API processes in a pharmaceutical environment with ISO 14644 Class 7 and 8 rooms. Projects with customers are typically started with comprehensive technical information packages that contain all information required by the customer for dosage form development and regulatory filings. Ongoing support is given by sharing of specifications, analytical procedures, validation documents, and reference and impurity standards from a unique program with currently more than 550 substances. Most importantly, in combination with the Pharma division Heumann can offer the one-stop shopping solution sought by an increasing number of customers: API and drug product manufacturing in one site. Regulatory compliance is a basic prerequisite for success in regulated international markets. Heumann’s track record of regulatory inspections and customer audits is outstanding, the three latest FDA inspections were passed without a Form 483 issued. More than 50 annually updated Drug Master Files are submitted in the US, Europe and other countries and Heumann further on holds 11 CEP’s for its major products.