Highly potency & oncology APIs

FCC 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.

At Fine Chemicals Corporation our HPAPIs are produced in units with OEB 4 and 5 classifications. Our heritage in manufacturing complex HPAPIs has enabled FCC to establish world class systems and procedures for safe handling of these compounds.

At Fine Chemicals Corporation, cytotoxic product manufacturing is carried out in dedicated purpose-built facilities. Our anti-spasmodic, narcotic and oncology products such as Vinblastine Sulphate and Vincristine Sulphate are manufactured from plant source. Our oncology products are manufactured by unique in-house methods using chromatography in a dedicated facility.

Manufacturing capabilities

• Manufacturing under full cGMP
• Batches ranging from 0.5 kg to <400 kg API
• Commercial manufacturing ranging from 63 to 6300 liters
• Best-in-class cleaning procedures
• Isolator technology for micronization and milling of OEB 4 and 5 compounds
• ISO 8 air quality 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 

World leading API products which are manufactured and not limited to: