Pharmaceutical APIs And GMP Consulting

Filed in Health and Fitness on Feb.04, 2010

In the past decade, many pharmaceutical companies have outsourced ingredient production to Asian countries including China and India in the hope of lowering production costs and increasing profits. But now GMP Consulting firms are seeing companies move this production back onto US soil. The reasons behind the move back to the US are varied and they will be discussed in this article.

Pharmaceutical companies were looking for cheaper costs and bigger profits when they moved the production if Active Pharmaceutical Ingredients or APIs to Asia. Production costs like labour and premises rent is better value than in the US. However, now manufacturers are beginning to realise that there are many costs and logistical issues which make this outsourcing more expensive than first thought.

Quality Issues
The US has been scrutinising the quality of Asian-produced drugs since the contaminated Heparin affair last year which saw death and serious illness across the nation. Now, consumers, healthcare professionals and drug producers are demanding high quality ingredients and they are looking for the security that US manufacture provides. 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. And now the pharmaceutical companies are truly beginning to realise the true cost of this outsourcing. There are costs for employing solicitors, for hiring offices and for travel. These expenses on top of the other complications that are involved in oversees outsourcing can add up.

Communication Problems
When you outsource products overseas, communication is often the most complicated factor. And when you can barely get through a daily conversation without becoming confused, how are you supposed to clearly convey technical information. Communication will also be slowed down when you have to compete with different time zones. You are putting your company at a poor position when you have to wait for time zones to align in order for you to be able to communicate with your suppliers abroad.

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.