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GVK BIO Announces USFDA Approval for its cGMP Analytical Services Laboratory

July 03, 2019

The company received No Action Indicated (NAI) compliance status with zero 483 observations

Hyderabad, India — July 03, 2019 — GVK BIO, a leading global Contract Research and Development Organisation, announced today that United States Food and Drug Administration (FDA) has approved its cGMP Analytical Service Laboratory located at IDA, Mallapur Campus, Hyderabad. The inspection was conducted between May 1 to May 03, 2019 and the audit was concluded with NIL 483 observations. The company received No Action Indicated (NAI) compliance status with zero 483 observations from the USFDA which signifies compliance and conformance to applicable cGMP regulations.

According to Mr. Manni Kantipudi, Director & CEO GVK BIO, “The USFDA clearance with zero 483 observations and the NAI is a testimony to GVK BIO’s commitment to global standards of quality and compliance. At GVK BIO, ‘Safety, Quality and Compliance’ come before Business and Quality is given the highest priority. In addition to the USFDA accreditation the facility has an ISO 17025 NABL accreditation, CDSCO/DCA Approval, FEI# 3011573185 and DUNS number- 650953990.”

GVK BIO offers a range of Formulations & Analytical Solutions that include pre-formulation development, formulation development, analytical R&D, reformulation, stability studies, clinical supplies and manufacturing of exhibit batches. Our expertise in Analytical Solutions address the most complex challenges right from research, chemical, analytical to quality control in the drug development process.

Our Analytical Solutions include, analytical method development, validations & optimization, identification and isolation of trace level impurities, method development & quantification of genotoxic impurities and trace elemental, characterization of polymorphs/pseudo polymorphs, stability studies, dissolution profile, particle size distribution analysis, extractable and leachable Studies and Microbiology. We also perform stability analysis of drug products and active ingredient (APIs), packaging as per ICH, quality control testing and release as per cGMP requirements.

GVK BIO, a leading Contract Research & Development Organization servicing the global Biopharma industry; is headquartered in Hyderabad, India with operations in five sites including California, USA. Established in 2001, GVK BIO has over 18 years of experience across the Research and Development value chain with a focus on speed and quality while ensuring safety and compliance. GVK BIO’s team of over 2100 highly qualified scientists, backed by a no-conflict business model, well-defined and scalable processes, modern facilities, and a strong customer-centric partnering approach, focus on bringing its customers’ products to market.