The Mumbai based Accutest Research Lab (I) Pvt Ltd recently entered into a strategic alliance with the leading contract research organisation, Fuji Biomedix Company Ltd to cater the needs of Japanese pharma market.
The alliance is expected to support Accutest an Indian CRO with largest number of US FDA approvals, which has already established business development activities in the Japanese market. The company, recently received US FDA approval for its 21st biostudy, is conducting BA/BE studies for the Indian firms in Japan. The company which provides an array of services, has its core expertise in BA/BE studies, Phase I to Phase IV clinical trials and formulation development.
Commenting on this development Dr Satish Sawant, director and founder Accutest India, said, "21 US FDA approvals are an indication of our commitment to quality, technology and processes. It is the teamwork that has enabled us to achieve this honour".
The Accutest, with three centres in India, Mumbai, Pune and Ahmedabad, have conducted 200 studies till date. Out of which 88 submissions are to US FDA, 11 submissions to WHO, and 31submissions to EMEA, 8 submissions to ANVISA, 6 submissions to Canada and 44 submissions to other regulatory bodies. The company under its expansion programme has expanded its all the three facilities. The facilities have a combined capacity of 190 beds and 16 LC-MS/MS including the API 5000 in addition to API -2000, 3000, 4000, Thermofinigans And Waters.
Accutest has a separate 28-bed Phase 1 facility in Deenanath Mangeshkar Hospital, Pune.
An entirely new laboratory has been set up for the Formulation Development (F&D) at Mahape, Navi Mumbai. The F&D has 16 scientists working in the team. It plans to become a 'total partner in drug development process' by 2010. It conducts clinical bioavailability studies throughout the major stages of drug development.
With the objective to emerge as the complete partner in drug development, in August 2006, the company forayed into formulations development activity. A total area of 30000 sq ft has been earmarked for this activity. 1st phase spread over an area of 3500 sq ft is fully operational and the 2nd phase would be completed by December 2007.
The company, with class 100,000 GMP area and conforming to cGMP, offers services like pre-formulation, formulation of wide variety of dosage forms, analytical method development and validation, stability studies as per the ICH guidelines and product development report.