Almost every one of us is curious to know how much does it cost for a pharmaceutical company to produce a medicinal product. Before we get a realistic answer we need to understand the detailed specifications of the company’s aims / targets and essentials for the medicine with respect to manufacturing, quality control, quality assurance, packaging, labeling and regulatory submission involved behind the ‘Making of the medicinal product’.
A tablet preparation is available in variety of forms and functions, which can have an impact on price.
In this context first we need to look from a production angle what will be the mode of operation for the preparation of the tablet. This can be best assessed in the operating mechanism, whether it’s an immediate release, modified release, sustained release or bio-adhesive and many more and will be formulated with its own active pharmaceutical ingredients and excipients.
Usually, sustained release tablets’ cost will be little expensive due to specialized polymers while immediate release tablets are produced with less steps and are available at lower costs. Whereas controlled release involves complex processes, which can step up the production costs. Other formulations such as bi-layer tablets, can give added costs due to multiple production steps. Again coated or not coated tablets will have important impact on cost. Coated tablets can add approx 25- 30% production hours and thus finished product costs will be changing.
Tablet Composition vs. EHS (Environmental Health and Safety) factors
EHS has an important role in deriving the cost of the tablets. We know each medicine is composed of active pharmaceutical ingredient (API which has its own mechanism of action and unique steps for preparations. Therefore bio-pharma companies follow strict EHS practices to protect their resources as well as society & environment from the hazards. Drug companies classify the API in terms of safety and then implement with the required compliance procedures. These entire practices directly influence the cost of the overall product.
Specialized packaging elements often subject to taking in to specialized change components.
Many of the medical products need unique packaging in specialized container & closure. Cost derivation depends on the packaging elements such as a specialized container or a unique container closure system. This packaging cost is reflected in the overall cost of the product.
Analytical testing, regulatory parameters also play important roles in the overall costing of the product. So it is quite difficult for us to find out the costing of tablet or any pharmaceutical finished product as several parameters are involved like product technical data, machinery, resource, regulatory strategy and many more.