Press release from Business Wire India
Source: GVK Biosciences Private Limited
Wednesday, March 18, 2009 01:10 PM IST (07:40 AM GMT)
Editors: General: Consumer interest; Business: Business services, Healthcare, biotechnology & pharmaceutical; Healthcare
Release no: 19492
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GVK Biosciences gets Approval from Ministry of Health, Turkey for Bioequivalence Studies
Hyderabad, Andhra Pradesh, India, Wednesday, March 18, 2009 -- (Business Wire India) -- The GVK Biosciences (GVK BIO) Clinical Pharmacology Unit at Hyderabad was inspected by a three-member delegation from Ministry of Health, Turkey and 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 GVK BIO to cater to generic drug manufacturers in Turkey as well as to those who intend to market their generic drug products in Turkey.
The Clinical Pharmacology Unit carries out Bioequivalence studies meeting international regulatory requirements like USFDA (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.
About Clinical Pharmacology Unit (CPU)
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 bioanalytical needs of Big Pharmas' new chemical entities (NCEs).
About GVK BIO
GVK Biosciences (www.gvkbio.com), Asia's leading Contract Research Organization, delivers integrated research services to Big Pharma and Biotech companies globally. GVK BIO accelerates the drug discovery and development process of its customers through science and innovation. GVK BIO has a diverse customer portfolio including 15 Big Pharma companies, Agri & Life-sciences companies, leading biotechs and academic institutions. Headquartered in Hyderabad, India, GVK BIO has more than 1,500 employees spread across research facilities in Hyderabad, Chennai, Mumbai and Gurgaon in India.
For any further information, please contact: bdcpu@gvkbio.com
CONTACT DETAILS
Sharada Alvakonda, Dy. General Manager - Corporate Communications, GVK Biosciences Private Limited, +91 (40) 66929999, sharada@gvkbio.com
KEYWORDS
CONSUMER, BUSINESS SERVICES, HEALTHCARE, HEALTHCARE
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