Whether you access standalone API manufacturing service or require API in conjunction with finished dosage form manufacturing capabilities, our CDMO partner can add value to your project incl.below:
API – MANUFACTURING SERVICES
Expert team currently manufactures over 30 different APIs on-site, distributing to over 50 countries around the world. You can access products from own generic opiate API manufacturing portfolio or use custom API manufacturing services.
Due to its range of facilities and technologies, production site is highly suited to the production of complex, multi-step products. You can acces also the high- level security required to manufacture controlled drugs, Pharma´s range of opiate APIs.
All facilities comply with European Good Manufacturing Practice (cGMP). The Pharmaceutical and Medical Device Agency (PMDA) and the Ministry of Food and Drug Safety (MFDS) have inspected sites and given their seal of approval, which can meet your supply needs in Japan and Korea, too.
Expertise
Experienced team of synthetic and analytical chemists are committed to delivering focused solutions to your API manufacturing challenges, complemented by our highly experienced regulatory professionals and supply chain experts to ensure all aspects of your API project are handled with expert care.
API manufacturing services incorporate a wide range of processes including:
- equipment for different chemical reactions, purification, isolation, drying, sieving, milling and micronisation
- manufacturing pilot, pre-validation, validation and commercial batches
- in process control and technological supervision through all phases of manufacturing
- cleaning verification and validation
- stability testing
- REACH agenda
preparing DMF and CEP support documentation