The United States Pharmacopoeia, a non-governmental official public standards-setting authority for prescription and over-the-counter medicines and other healthcare products manufactured or sold in the United States, is expected to complete the expansion of its facility in Hyderabad by April this year.
The Hyderabad facility of the USP, which opened in the ICICI Knowledge Park in 2006, has an area of about 15000 sq feet at present and the new building will increase it 10 fold. The expansion involves an investment of US$ 15 million. It will be the largest centre of the USP outside the US after the expansion is completed. Currently, it has facilities to do analytical research and development, microbiology etc. Now it is in the process of setting up of bio-analytical laboratory.
Commenting on the expansion, Roger Williams, CEO, USP, told, Pharmabiz, “We believe it will be very beneficial to the Indian companies because they can use the facility to show the world that they are adopting best standards. It will also be useful for exporters for shipping ingredients to the buyers and for getting into the American market.” He added that the USP has laboratories all over the world, including Basel in Switzerland, Shanghai in China, Sao Paulo in Brazil and Hyderabad in India. The first offshore facility of the USP was in Hyderabad and it has been very successful, and therefore the first expansion is also in Hyderabad.
The main service that companies can avail from the facility is the reference standards provided by the USP. In addition it will provide US pharmacological courses and help in assuring quality of active pharmaceutical ingredients and dietary supplements.
“We also offer verification services by which manufacturers of active pharmaceutical ingredients, drug substances, excipients and dietary supplements can come to us and we will conduct an audit and do a documentary review and make sure the product used is right quality and is manufactured as per good manufacturing conditions that assure the consistency in quality of the products and ingredients. We provide some of the verification services in our Hyderabad facility”, said, V Srini Srinivasan, head, international sites and verification programmes, USP.