Simplifying The Supply Chain With Large-Volume Western CDMO Partners

When considering primary and secondary sourcing options, it is important to balance price and security of supply. Partnering with an integrated, Western contract development and manufacturing organization (CDMO) with large-volume production capabilities for registered starting materials (RSMs), advanced intermediates, and active pharmaceutical ingredients (APIs) can provide countless advantages, including reliability and superior communication, at a competitive cost.

Quality and Reliability Benefits of Partnering with European CDMOs

Even just 10 years ago, it was common practice for pharmaceutical companies to purchase RSMs and intermediates from low-cost manufacturers in China and India. Cheap labor and limited environmental and safety regulations led to significant cost differentials.

However, in the past few years the Chinese government has implemented new environmental, health, and safety regulations and policies moving closer to the stricter requirements found in Western countries. Many older Chinese plants have been shuttered, and additional closures continue to occur on a frequent basis. Prices are rising, and in some cases products are no longer available, leading to significant supply interruptions while a new source is established. In India, issues related to quality problems are frequently reported by established pharmaceutical newsletters and often can be traced back to noncompliance with cGMP manufacturing requirements. In 2019, Indian pharmaceutical companies received 19 of the 41 warning letters issued by the U.S. FDA, the country’s most in four years.¹ In some cases, these quality issues are severe enough to halt import of products into Western countries. 

Regardless of where a CDMO is located, pharmaceutical companies should look to partner with service providers that are committed to forming strategic collaborations and long-term relationships.