Manufacturing capabilities

FCC has a heritage of serving a stable customer portfolio comprising, among others, multinationals, generic manufacturers and innovative new tech start-up companies. We have established expertise and capability to develop, scale-up and commercially manufacture complex APIs. These competencies ensure that when you engage with FCC, you will be working with a reliable high-quality partner.

API chemical manufacturing capabilities

FCC specializes in chemical reactions and can combine this with developing the most efficient processes. Supported by a robust quality system, we ensure a high-quality product that is manufactured in compliance with cGMP, ICH and SHE regulations and standards. Through our global FCC network, we ensure flexibility and delivery reliability.

Expertise with HPAPIs

At FCC one of our strengths lies in manufacturing APIs at various production scales with a specialization in HPAPIs. Our HPAPIs are produced in units with OEB 4 and 5 classifications. We have a longstanding history of working with OEL levels as low as 0.05 μg/m3. Our heritage of manufacturing complex HPAPIs has enabled us to establish world class systems and procedures for the safe handling of these compounds.

Manufacturing facilities

Our cGMP production facilities are able to produce products from gram to kilo quantities to support clinical and commercial demands. All our facilities have been successfully inspected and approved by international health authorities, including the US FDA, EDQM, PMDA, as well as by our customers.

Our API infrastructure and capabilities

• FCC has a good balance of multi-purpose and fully segregated API manufacturing API facilities 
• A large range of specialised API manufacturing equipment including 75 stainless steel, glass lined and C22 reactor vessels ranging from 63 liters to 6300 liters.
• A good diversity of drying equipment including tray dryers, ANFD’s and agitated conical dryers 
• Large scale purification through crystallization, filtration and chromatography.
• State-of-the-art Powder Processing and Dispensing unit for sieving, milling and micronization.
• Batches are manufactured varying from grams to <400 kilograms. All finished products are handled in controlled environments that are designed and qualified by independent contractors to ISO 8 air quality standards as per ISO 14644.
• Manufacturing of alkaloids, heterocycles, narcotics, and cytotoxins. 
• Containment capability for manufacturing and handling HPAPI products from OEL 1 ug/m³ to 50 ng/m³ (TWA).