Pharma/Fine Chemicals Case Study #1
A European API producer wanted to source one advanced intermediate from China. Although the product was available from the internet and from various traders, they were looking for a reliable source with low and stable prices but also insurance that they could qualify this starting material and list the source in their DMF. They needed the plant to be not only audited but also monitored by QA professionals in China.
They also wanted to be able to exchange with a reliable, knowledgeable and well equipped QC on the impurity profile of this intermediate as it had an impact on the impurity profile of their API. As they had to answer questions from agencies and customers that could not suffer delayed or vague answers, they needed responsiveness and accuracy. Eastarperfectly matched all the customer’s expectations. The customer’s project was successfully carried out and it continues to be managed reliably by Eastar.