API Development and Manufacture
Almac’s strength in API development and manufacture is proven by being the partner of choice for many pharma and biotech companies seeking integrated drug development solutions from molecule to market.
Our technical expertise and extensive facilities enable us to offer integrated API contract manufacturing solutions through all stages of the drug development lifecycle. We are fully supported by dedicated analytical and regulatory teams.
In addition, we offer numerous support capabilities, including: rapid implementation of chromatography for purification, containment equipment for potent compounds and micronisation to control particle size. Our dynamic team successfully address many complex project challenges, and implementing our on-site biocatalysis technology expertise is one example of our responsive solutions.
Project management is critical for the effective execution and delivery of our customers’ complex projects. Our project managers are experienced scientists, working with clients to anticipate and respond to project priorities.
Almac has an excellent regulatory history with regular inspections by all appropriate regulatory bodies (FDA, MHRA) and our clients.
API Development and Manufacture – Early Phase
API Development and Manufacture – Late Phase