GVK Biosciences Clinical Pharmacology Unit at Hyderabad which was inspected by a three-member delegation from Ministry of Health, Turkey has been approved for conducting bioequivalence studies.
The team from the Ministry of Health, Turkey inspected the facility and carried out a detailed audit of the facility for systems and processes meeting Good Clinical Practice (GCP) and Good Laboratory Practices (GLP) requirements, before granting approval.
This approval enables us to cater to generic drug manufacturers in Turkey as well as to those who intend to market their generic drug products in Turkey, Manni Kantipudi, president, GVK Biosciences said.
The Clinical Pharmacology Unit carries out Bioequivalence studies meeting international regulatory requirements like US FDA (USA), ANVISA (Brazil), AFSSAPS (France) and WHO (World Health Organization, Geneva) and has successfully cleared their audits. These accreditations coupled with GVK BIO's delivery engine, has helped GVK BIO build a loyal and growing list of top generic drug players globally and in India.
The Clinical Laboratory is also accredited by NABL (National Accreditation Board for testing and calibration Laboratories), Department of Science and Technology, Govt of India for meeting ISO 15189:2007 standards.
The Clinical Pharmacology Unit (CPU) located at Hyderabad, is one of the largest units in India for Bioavailability and Bioequivalence studies with state-of-the-art infrastructure to cater to global regulatory requirements. This CPU with 144 beds and a comprehensive volunteer database has the capability of undertaking studies for special population and dosage forms like injectables in addition to the conventional studies, which sets it apart from the competition. As of now, CPU has conducted around 500 studies of which 100 studies are for USFDA submission. The bioanalytical unit of CPU has developed and validated more than 150 bioanalytical methods for generic drug molecules including some of the most complicated ones. It also has been catering to the bio-analytical needs of Big Pharmas' new chemical entities (NCEs).