Pharmaceutical formulation intermediate (PFI) is a blend of active substances and excipients, frequently in a powdered form. On the other hand, an API is separately made and contains pharmacologically active ingredients or those that act on the symptoms of a disease.
API is the abbreviation for the active pharmaceutical ingredient, which is the chemical that makes the medicine work. Formulation refers to the finished product or intermediate stages in which various chemicals, including the active ingredients, are combined in specific ratios to produce a particular drug.
When you purchase a Paracetamol 500mg tablet, you are buying the API or active ingredient: 500mg of Paracetamol. However, in addition to this active ingredient, the tablet may also contain some colourants, fillers, preservatives, binders and other elements necessary for its production. These additional ingredients include maize starch, stearic acid soluble starch, and povidone.
An understanding of the legal aspect
After obtaining the approval number, pharmaceutical management requires that APIs be registered with the Drug Regulatory Authority and synthesized in a Good Manufacturing Practice-compliant plant. After receiving the approval number, pharmaceutical management requires that APIs be registered with the Drug Regulatory Authority and synthesized in a Good Manufacturing Practice-compliant plant.
Generally, APIs and PFIs are manufactured by pharmaceutical companies in their home countries. But many companies have chosen to shift their manufacturing overseas in recent years to reduce costs.
A pharmaceutical company must decide between purchasing a PFI or an API.
Acu process manufacturing is an innovative, cost-effective and safe technology that major pharmaceutical companies use for API formulation. The primary objective behind Acu process manufacturing is to eliminate the need for scales and processes used in traditional viscous mixing. The process involves dissolving the API in an organic solvent at low temperature with ultrasound energy to yield pure products by eliminating any impurities in the raw material.
Partnering with an external vendor for PFIs can be more profitable than handling PFI tasks internally.
Suppose large drug manufacturers want to save on expenditures to curb extra spending. In that case, they might need to decrease the number of suppliers they work with, especially during tough times like the Covid pandemic or other unexpected events.
From a supply chain management perspective, if there is a cross consolidation between APIs and PFIs, they will not have to deal with multiple suppliers like earlier.
Moreover, many pharmaceutical companies are in the UK and US, while most API manufacturers are overseas. Because finished dosage manufacturers purchase APIs from suppliers and manufacture PFIs in-house, the cost incurred for its technical production is way high (i.e., significantly higher than that of a typical product), increasing their testing costs. That said, many drug manufacturers these days prefer purchasing PFIs from a specialized manufacturer to reduce the cost and increase their ROI. (i.e., return on investment) so that they don’t have to make PFIs in-house and invest in machinery and human resources.
About Acu Process Manufacturing
Acu Process Manufacturing delivers cloud ERP that helps manufacturers meet the challenges of global competition. Get access to a single integrated system across finance, manufacturing and operations. Our secure cloud-based ERP solution can help improve efficiency in your business with increased automation and real-time visibility into production, inventory and supply chain management.
Sangeetha brings 20 years of experience in Information Technology which includes Solution architecting, building micro services, research, and evaluation of business applications, integrating apps.