Outsourcing APIs And GMP Consulting
Pharmaceutical companies have been outsourcing the production if ingredients from US production companies to Asia. GMP consultants have however recently announced that more ingredient manufacturing is returning to the US. The reasons behind the move back to the US are varied and they will be discussed in this article.
When pharmaceutical companies decided to move the production if Active Pharmaceutical Ingredients (APIs) to Asia, they thought they would be getting a good deal on price. Production costs like labour and premises rent is better value than in the US. However, hidden costs in terms of logistics and communication are making this outsourcing more expensive than they expected.
Quality Issues
After the deaths and illnesses caused by contaminated Heparin that has been produced in China made its way onto the US market, the quality of drugs made in Asia has been under question. And we have seen a bigger demand for quality products made on American soil from consumers, healthcare professionals and the pharmaceutical companies. Quality is stringently measured by the FDA so GMP regulations have to be met by US based manufacturers.
Logistics
The logistics behind outsourcing part of the drug production to a country on the opposite side of the world are massive and expensive. The costs of this are now hitting home. Additional costs include the price to hire a translator, any travel that takes place between the countries and renting out offices or production space. These expenses on top of the other complications that are involved in oversees outsourcing can add up.
Communication Issues
As was mentioned in logisitcs, many manufacturers have to hire translators to interpret all of their communication between themselves and their foreign partners. And when you can barely get through a daily conversation without becoming confused, how are you supposed to clearly convey technical information. Pharmaceutical companies also need to take into account the different time zones that the continents are on and this will slow down communication. Consumers and regulators demand instant information and when you have to wait for your partners to start their working day before you can get in touch with them, you put yourself in a difficult position.
Pharmaceutical companies have not seen the high profits that they expected to see after outsourcing their ingredient manufacture to Asia. In fact, by moving your production back to the US you are filling your customers with confidence of quality and can make bigger profits.
Tags: APIs, gmp consultants, GMP Consulting, pharmaceutical ingredients