By IANS,
Hyderabad : GVK Biosciences, a leading contract research organisation, Wednesday said it has received approval from Turkey to conduct bioequivalence studies.
A three-member delegation from Turkey’s ministry of health inspected the GVK Bio clinical pharmacology unit (CPU) here and carried out a detailed audit of the facility for systems and processes.
This approval enables GVK Bio to cater to generic drug manufacturers in Turkey as well as to those who intend to market their products in the country, said a statement from GVK Bio.
The clinical pharmacology unit carries out bioequivalence studies meeting international regulatory requirements of the Food and Drug Administration (US), ANVISA (Brazil), AFSSAPS (France) and World Health Organization (Geneva).
“These accreditations, coupled with GVK Bio’s delivery engine, have helped GVK Bio build a loyal and growing list of top generic drug players globally and in India,” it said.
The clinical pharmacology unit 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. The CPU has conducted around 500 studies of which 100 studies are for FDA submission.