Owning and running a tadalafil powder factory requires meticulous procedures. Tadalafil is a raw material for the production of APIs and generics, which are products intended to treat erectile dysfunction primarily. There are ones on the market that cost up to $10,000 per kg for high-quality raw materials in order to make sure they work correctly and are safe.
In first phase raw materials go through some very rigid quality controls tests. These tests determine purity and represent 20% of the total cost of production, ensuring nothing but a maximum of.1 % impurity. The production environment should be controlled at a temperature of 20~25 ° C and humidity <30% to ensure that the active pharmaceutical ingredient(API) does not deteriorate.
The chemical synthesis of tadalafil is a complex process. Temperature of reaction, which is usually set at 75°C for around 48 hours and the mixture synthesized needs to then be purified using crystallization or by filtration. The crystallization process necessary to achieve the desired purity can yield pure tadalafil with a level of 99.5%.
This powder is tested by a variety of standards regulation bodies such as the FDA & EMA after synthesis. On top of price, tests like High-Performance Liquid Chromatography (HPLC) to validate purity levels at about $1,500 per batch. It helps the market approval and protects buyers.
The second part is, of course packaging and uplifting which are vital processes for the production also. Once the nutrient syrup is blended and balanced, it is then put in moisture-tight containers to keep it stable well beyond its 24-month shelf life under optimal conditions. Packaging is done with robots that help produce, increase efficiency and reduce labor costs by 15%.
An example of a strict regulatory compliance is the recall incident faced by a top pharmaceutical company in 2018. The company found itself pulling 1.2 million tablets off the shelves at a cost of more than $5 million after it failed to meet purity standards The incident proves the point that quality control should take place every single step of production.
By and large, to run a Tadalafil Powder Factory takes meticulous attentionto every aspect of the business process as well significant financial investmentand adherence to some of the strict regulations. The partner understands the pharmacovigilance system and auditing procedures as well to meet industry regulations for tadalafil powder production decisions.