AMRI builds upon Indian operations

New York-based AMRI has added to its Indian operations, following the acquisition of another manufacturing plant in the country.

The firm has bought Aurangabad-based FineKem Laboratories, for a reported price tag of "less than $2m" and the acquisition is expected to "significantly accelerate" AMRI's ability to make custom pilot scale intermediates in India.

The company already has chemical development process capabilities in Hyderabad, along with manufacturing facilities in Aurangabad and Navi Mumbai, and a company spokesperson said the new facility will help to "build a bridge" between all these facilities.

Production at the new site is expected to commence in the second quarter of 2008 with around 20 employees, although up until this time AMRI said it intends to implement upgrades over the next few months to bring the existing facilities into compliance with US Food and Drug Administration (FDA) regulations for the manufacturing of clinical trial materials and commercial drug substances.

Under the purchase arrangement, FineKem's managing director, Rakesh Doshi, will join AMRI India as executive director and COO, reporting to Dr Prasad Raje, managing director of AMRI's current Aurangabad and Navi Mumbai facilities.

AMRI chairman, president and CEO Thomas D'Ambra said: "As we continue to explore and expand the ability of AMRI to provide value and flexibility around the globe, the purchase of this site increases the cost-competitive solutions available to our customers for their outsourcing needs."

The US-based contract manufacturer has been busily embracing India with the purchase and construction of infrastructure to cement itself in this popular location.

The firm has invested heavily in analytical chemistry services in the country.

In October last year it had 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," said company spokesperson Garrett Dilley in an interview at the time.

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, as well as a new kilo lab.

The laboratories have also been given GMP status and so preclinical and clinical manufacturing services, such as chromatographic assays, stress degradation and method validation can be performed there, Dilly clarified.

Meanwhile, in July 2007 the company obtained its two manufacturing facilities in Aurangabad and in Navi Mumbai.

These two facilities currently make active pharmaceutical ingredients (APIs) as well as intermediates for the domestic market, although 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 this year.