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Key considerations when sourcing pharmaceutical materials By Tanja Schaffer, Vice President Global Pharmaceutical Industry

Colorful test tubes

Finding the right supplier for your pharmaceutical intermediates and ingredients will make or break your business

As the pharmaceutical industry becomes more competitive and processes more rigorous, manufacturers are hard pressed to manage a complex network of raw material suppliers including for pharmaceutical ingredients. For example, China’s pharmaceutical industry alone needs more than 2,000 types of raw materials and intermediates to meet its market demand each year.

When we talk about pharmaceutical ingredients, it usually involves the following components: pharmaceutical intermediates and active pharmaceutical ingredients (APIs). For the layman, pharmaceutical intermediates are chemical compounds that form the building blocks used to produce APIs, while APIs are the substances used in the manufacture of drug products.

Here are some key considerations you need to think about when sourcing for materials for your business: 

 

The pharmaceutical supply chain is a complex process. There are stringent manufacturing processes to abide by and intricate regulatory requirements to be familiar with in each respective market you are intending to enter.

The constantly changing market and pricing trends and the rising number of specialized drugs available in the market today have also resulted in the increase in the complexity of these compounds and raw materials used to develop new drugs.

As these ingredients are used in a highly regulated market, any alteration to the quality of raw materials or any single change can affect the final product’s quality and consumer safety. Any mishap at this stage could prove costly for your business.

Despite the industry being a highly regulated one, untoward accidents do occur. Whether it is disruption to the supply of intermediates and APIs following natural disasters or contamination of raw materials, often, the entire industry, from manufacturers right up to consumers, is affected.

With consumers becoming more conscious of the choices available in the market, manufacturers are seeking out suppliers with credible environment-conscious processes, good manufacturing practices and eco-friendly products. For manufacturers looking to source raw materials from suppliers in emerging markets, a major challenge is to ensure supply chain transparency.

Manufacturers must seek out suppliers that have in place fully compliant audit and process controls throughout their supply chain. These suppliers must, for example, can readily share data about their manufacturing procedures, technical capabilities and quality control measures taken.

A good place to source for pharmaceutical intermediates and APIs will be the upcoming Chemspec Europe exhibition. To be held in Munich, Germany, from May 31-June 1, the event features leading manufacturers, suppliers and distributors of fine and specialty chemicals from all over the world.

Together with the more than 320 exhibitors from 24 countries, DKSH will be showcasing its diverse portfolio including APIs, intermediates, excipients, coupling agents and activating agents. Come and meet us at Chemspec Europe, or drop me a thought here on what your current challenges in finding the right sources for pharmaceutical materials, intermediates or APIs are.

Tanja Schaffer

About the author

Tanja Schaffer is a doctor in chemistry, based in Switzerland. She is currently responsible for DKSH’s Business Line Pharmaceutical Industry globally (excluding Japan).