Antibiotics and anti-infectives

Several of these products have special manufacturing requirements. Beta-lactam antibiotics must be made in segregated facilities to avoid cross-contamination, and sterile APIs for injections need aseptic processing and endotoxin testing. Fermentation-derived antibiotics are often supplied as intermediates, such as 6-APA and 7-ACA, which are converted to the final product by semi-synthesis.

Specify the salt or hydrate form (for example amoxicillin trihydrate or ceftriaxone sodium), sterile or non-sterile grade, potency, related substances, residual solvents and, where relevant, microbial limits. Ask for the regulatory dossier status for your market. Veterinary grades exist for some antibiotics and should not be confused with human-use grades. In customs, antibiotics fall under HS heading 2941, while many synthetic antivirals and antifungals are classified as heterocycles.