Pharmaceutical Formulation Intermediates (PFIs) have lesser shortfalls compared to APIs and also have a more stable shelf life and are less prone to temperature variations.
By purchasing PFIs, customers can focus their time on producing tablets instead of trying to create the proper granulation blend. In addition, PFIs can be designed to replicate the release properties of a brand leader’s finished dosage, so the manufacturer will have an easier time passing the bio-availability studies.
However PFIs require their own unique manufacturing equipment. Its machinery is expensive and complex, which makes it uneconomically and non feasible for customers to make their own PFI. Thus due to the complexity of the machinery, PFIs contribute to 80 per cent of the total cost of manufacturing a finished dosage.
In addition, there are many different processes and equipment a manufacturer can choose such as opting for a fluid bed dryer or rapid shear mix. The customer would have to learn the nuances of the machine and understand which technology is ideal for a particular finished dosage. In addition, customers tend to buy small-scale equipment to suit their immediate needs. This increases cost since they need to test for each batch and also reduces flexibility in case demand increases. By purchasing PFIs from a specialized player such as Granules, customers can reduce their costs and increase their ROI since they do not need to invest in machinery, technical know-how and personnel.
Finished dosage manufacturers would purchase Active Pharmaceutical Ingredients (APIs) from suppliers and manufacture PFIs in-house in order to prepare the material for finished dosage manufacturing. However, since most manufacturers only produce low volumes, they would create PFIs on a small-scale basis, which increase their testing costs. In addition, since they have multiple products, their facilities would not be properly utilized. They will also have to ensure clean practices in facility and production. The companies will need to clean the equipment after manufacturing a particular product. In addition, the user would need to have a complex supply chain since they would need several excipients. This would entail additional costs since the user would need to audit their suppliers and also keep a ready inventory of material in the warehouse. Finally, if a manufacturer wants to make a new product, they would needs to gain the expertise to make a particular PFI which involves allocating a large portion of technological resources with no guarantee to develop a cost-efficient product.
Hyderabad-based Granules pioneered the concept of marketing PFIs when they realized that it could provide substantial value to customers by producing the same on a large-scale basis.
The company commenced production of PFI in 1991, which was an unconventional business model. But today it has the largest facility in the world. By doing this, it provided compelling value to customers since it reduced their total cost, allowed for higher utilization of employees and equipment along with quicker access to market. Over time, the company continued to develop its expertise in the manufacturing of PFIs and added more value to customers by developing a process that uses a six ton batch size, which is the largest in the pharmaceutical world.
Many pharmaceutical manufacturers did not initially understand the value of commercializing PFIs. But now they have understood the nitty-gritty of manufacture which is why more companies are producing PFIs as a commercial product. However, Granules is the only company in the world that makes PFIs the core of its business model.
PFIs are a prime example of a manufacturing process to add value to the end-user. Some of Granule India’s PFIs are Ibuprofen and Metformin. Both are complex products that are difficult for many people to granulate.
There are an increasing number of companies look into expand their PFI manufacturing but very few of them are actively researching to find cost-effective production methods and are learning through a trial and error basis which will result in them taking a longer time to enter the market. Most companies are still choosing to focus on the API or Finished Dosage since because of being comfortable with them and prefer not to learn another new manufacturing process.
There are several Chinese companies that produce PFIs but they tend to focus on promoting their APIs . In the case of Granules, it is building on its 20 years of PFI manufacturing experience by having an in-house R&D team that develops process improvements.
The company focuses on finding more effective ways to manufacture the product. In addition, it works closely with several institutions to improve our PFI knowledge base by implementing granulation concepts from other industries.
The PFI market is the same size as the API market since it involves taking APIs and adding excipients to make the proper blend for the Finished Dosage. Most PFIs are made in-house, particularly for low volume drugs so the market size can vary based on one assumption.
There are several companies that manufacture PFIs on a commercial basis but very few of them actively promote their PFIs over their APIs or Finished Dosages. Granules is the forefront leader of PFIs since the company has gained a tremendous knowledge base by producing PFIs on a commercial basis for over 20 years, said Krishna Prasad Chigurupati, managing director, Granules India.
The opportunity in PFIs will continue to grow due to the value proposition of the product. Due to the rising cost of procuring APIs from non-regulated markets, the total cost of PFIs is lower than granulating your own APIs. This, in addition, with all the other benefits of PFIs such as lower regulatory costs, lower quality risks and a less complex supply chain have made PFIs the ideal product for customers who want to increase their profitability. In addition, more customers are looking at PFIs since their own in-house granulation equipment is obsolete and they cannot justify large capital expenditures when a third-party can offer significant savings, he added.
PFIs are challenging to efficiently manufacture on a large-scale basis, which is the primary cost-benefit driver. There are several companies that sell PFIs for commercial purposes but very few have been able to gain the technological know-how to quickly produce a PFI blend for their end customer. Manufacturers are able to granulate in-house but they might not be able to garner efficiencies if they. It takes time and experience to understand the unique characteristics of an API in order to manufacture a PFI that meets the required flow and compressibility characteristics.
Most companies have focused R&D efforts on API or Finished Dosage production. Companies that do not actively research PFI production will not be able to gather the competence that are required to create a cost-competitive product. Granules has over 20 years of technological experience which gives it an advantage over others in the market place. In addition, it works with outside consultants and universities to understand where it can make process improvements, he added.