Sourcing APIs: An overview
Costly and time-consuming, sourcing the right APIs can be arduous for many pharmaceutical businesses.
Increasingly, companies are finding that they need to have a more in-depth understanding of regulations, manufacturing processes and global supply chains just to stay ahead. Below, we highlight the key things pharma businesses need to consider when sourcing effective APIs.
Choosing the right API sourcing partners
First and foremost, manufacturers should question the long-term stability of potential partners. It is always important to consider if they can consistently offer the costs and flexibility needed to manufacture the products in question.
Quality is also key when it comes to choosing partners. Double checking that the company has a strong cGMP compliance record is a sensible place to start. It can be tempting to choose a business offering the lowest price, however, this may mean that quality is compromised. As such, manufacturers should always look into the reputation of the company before accepting a low-cost proposal.
Key concerns in the industry
One of the key concerns in the industry today is the sustainability of supplies. Because of this, contract development and manufacturing organisations (CDMOs) with strong links to good suppliers and raw materials are highly sought after, as supply shortages and time delays are extremely unlikely.
Here at Saneca, for example, our in-house morphine extraction is popular among prominent narcotic APIs. Because we have consistent access to our own supply of raw materials, complete control over our operations and long-term supply capabilities, we can always deliver competitive prices and high-quality products.
It is vital that pharmaceutical companies think carefully about logistics, suppliers must always have the relevant registration documentation needed to be included in marketing authorisation (MA) before commercial supply commences. Stability studies should also be carried out to determine the packing material, transportation and shipping conditions needed to ensure that the products are delivered safely and securely. The information collected at this stage should also be stored in an Active Substance Master File so that it can be referenced at any time during the product’s journey.
Over the past decade, multiple pressure groups have called on pharmaceutical companies to carefully consider the environmental credentials their API suppliers have. As a result, many firms have even begun asking for specific accreditations within their proposal requests.
Going forward, it is also more likely that customers will ask CDMOs what they are doing to reduce their carbon footprint, maximise their energy efficiency and incorporate green chemistries. This means that the industry as a whole will have to consider how it will be more environmentally friendly going forward.
What does the future hold?
China and India are undoubtedly the world leaders when it comes to supplying APIs. However, many manufacturers are now considering using APIs supplied in other parts of the world. This is, in part, because the rising cost of labour means that these countries are no longer seen as the only low-cost option.
This marks a key change in the industry as we know it today. Europe and the US are quickly becoming viable options for many companies, particularly for speciality APIs and companies requiring careful handling for their products.
Although many factors come into play when it comes to sourcing APIs, it is clear that pharmaceutical companies are placing increased value on factors such as reliable workforces, environmentally friendly systems and efficient logistics.
See our API development and manufacturing services to find out more.
And in this online exclusive, Tomasz Bokas, European CMO sales manager at Saneca Pharma, discusses the benefits of soft gel capsules, the manufacturing and handling considerations that should be considered and overcoming the potential barriers to their adoption by manufacturers.
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