AMRI embraces India
with the purchase and construction of infrastructure to cement
itself in this popular location, delegates heard at this year's
CPhI in Milan.
The firm has invested heavily in analytical chemistry services in the country, having recently completed construction of new contract research laboratories, moving from a smaller, leased site that it had occupied since 2005. "Feedback from our clients has been that contract research organisations in the country are undeveloped in regard to these services, in relation to both staff capabilities and technology investment," company spokesperson Garrett Dilley told Outsourcing-Pharma.com. The new 57,000 square foot facility in Hyderabad now has over 60 staff and focuses on lab scale custom synthesis and non-GMP analytical chemistry for preclinical drug substances and intermediates, and by December a new kilo lab will be up and running. The laboratories have just been given GMP status and so preclinical and clinical manufacturing services, such as chromatographic assays, stress degradation and method validation can be performed here, Dilly clarified. Meanwhile, the company has also recently acquired two manufacturing facilities, one in Aurangabad and one in Navi Mumbai. These two facilities currently make active pharmaceutical ingredients (APIs) as well as intermediates for the domestic market, however, the firm is looking to convert some capacity over to also making some of the intermediates here that are currently made at its New York facilities, by early next year, said Dilley. "Typically our US customers want their APIs made in the US, but for intermediates, cost is a major factor, so by giving them the opportunity to have their intermediates produced in India, we can offer them the chance to take advantage of the cost savings this country offers." The two Indian facilities are not US Food and Drug Administration (FDA) inspected, but Dilley said that AMRI is "interested in pursuing this avenue to bring the sites up to GMP standard." This would allow the manufacturing of some of the APIs to be also transferred from the New York site. However, there is no timeline for this, he said. "It depends on customer demand and the capacity left over after the intermediates are transferred here."
