Generics manufacturer Alvogen is investing in the contract research organisation (CRO) to support its own activities and generate additional revenues through the Indian clinical trial sector.
Norwich Clinical Services is setting up in Bangalore, India and will initially offer pharmacovigilance monitoring, bioanalytical studies and medical writing services. Later this year its offering will expand into Phase I to IV studies when a 60-bed clinical trial facility opens.
The facility is equipped to conduct pharmacokinetics in healthy volunteers, drug metabolism studies, bioavailability and bioequivalence work, dose proportionality trials and multiple dose investigations.
To support these activities Norwich has appointed people with experience of clinical research and the Indian market. Between them the team has completed more than 50 clinical trial programmes and 2,000 bioanalytical studies.
Alvogen predicts the CRO will employ 100 people within its first year of operation. Doug Drysdale, CEO of Alvogen, added that the CRO “will be a pivotal component to growing our business as we continue to expand capabilities to meet the demands associated with new markets”.
In addition to the CRO, Alvogen is setting up an active pharmaceutical ingredient (API) sourcing office in Bangalore. This will operate under the Alvogen name and help the company strengthen its relationships with Indian suppliers of raw materials.
For Norwich the CRO represents the latest step in a period of expansion. Earlier steps include investment in a pilot scale plant and addition of potent compound development capabilities.
Together these expansions represent a strategic shift to broaden the company’s offering, beyond its traditional focus on commercial manufacturing and packaging, to allow it to support clients throughout the lifecycle of a product.