Aspen API has expertise in manufacturing high potency APIs (HPAPIs) and cytotoxic APIs. Supported by a robust quality system, we produce a high quality product, manufactured in compliance with cGMP, ICH and SHE regulations.
Capabilities
At both Aspen Oss and Fine Chemicals Corporation our HPAPIs are produced in units with OEB 4 and 5 classifications. Aspen API has a long history in working with OEL levels going as low as 0.01 µg/m³. Our heritage in manufacturing complex HPAPIs has enabled Aspen API to establish world class systems and procedures for safe handling of these compounds.
At Fine Chemicals Corporation, cytotoxic product manufacturing is carried out in a dedicated purpose-built facility. Oncology products such as Vinblastine Sulfate and Vincristine Sulfate are manufactured from plant source by unique in-house methods using chromatography.
Manufacturing capabilities
- Manufacturing under full cGMP
- Batches ranging from 1 kg to 500 kg API
- Commercial manufacturing ranging from 100 to 10.000 liters
- Best-in-class cleaning procedures
- Isolator technology for micronization and milling of OEB 4 and 5 compounds
- Grade D clean room manufacturing for weighing and dispensing
Integration in our processes
- In-house SHE specialists with expert knowledge
- Well-trained staff and best-in-class safety protocols
- Safety assessments using calorimetry on processes, intermediates and APIs
- All intermediates and APIs on site assigned to OEB category
- ISO14001 and ISO 45001 certified
