PFIs

Pharmaceutical Formulation Intermediates (PFIs)

More than two decades ago, we pioneered the concept of commercialising of PFIs in the global pharmaceutical industry. We helped create the concept of a ‘ready-to-compress’ mix of APIs and excipients that could help compress and manufacture finished dosages into a one-step process.

Multiple actives: Paracetamol and Chlorpheniramine Maleate | Paracetamol and Diphenhydramine HCl | Ibuprofen and Pseudoephedrine HCl | Paracetamol and Caffeine

What is a PFI?

A PFI is the intermediate product between an API and a Finished Dosage. Sunaka pioneered the concept of commercialising PFIs, enabling customers to outsource the costliest component of finished dosage manufacturing. The proposition that PFIs could be outsourced was a radical notion that transformed the conventional pharmaceutical manufacturing model by offering customers significant savings, fewer handling hurdles and higher efficiency.

The Company’s concept is based on a ‘ready-to-compress’ mix of APIs and excipients that can be fed directly into a compression machine to manufacture finished dosages - a single step process.

Financial Benefits

Savings in capital expenditures and technical resources: In a typical oral solid dosage manufacturing facility, investment through the granulation stage accounts for up to 80% of the total cost. By providing a PFI outsourcing option, we help customers become attractively asset-light. By empowering customers to outsource PFIs, we have helped companies eliminate the need to reinvent the same granulation wheel, especially for difficult-to-granulate APIs like Ibuprofen and Ciprofloxacin. This has resulted in significant savings covering complex pre-formulation studies, process development and scale-up expenditure.

Lower testing costs: We possess an industry-leading six-ton PFI blender, which is 6-12x larger than the industry average. The result is that we can offer bigger batches at lower testing costs and higher product consistency.

Increased asset utilisation: We are liberating a number of customers from having to engage in time-consuming process and cleaning validation through a switch to PFI outsourcing.

Simplified supply chain: We are helping customers reduce the number of vendors they need to assess and reduce working capital since customers will can now buy from one source instead of multiple vendors.

Operational Benefits

Stability: Outsourcing PFIs from a dedicated specialist like us makes it possible for products to retain their compression and other quality characteristics throughout their shelf-life (compared with in-house granulations that remain stable for shorter periods).

Desired properties: The outsourcing of PFIs from specialists like us makes it possible to provide release properties similar to brand leaders, leading to finished dosage manufacturers getting favourable outcomes from their bioequivalence studies.

Dry Blending: We possess the capability for some PFIs to be dry-blended with other APIs without the need for further granulation to obtain homogeneous mixtures. This helps make finished dosage forms of controlled substances in combination with other APIs.