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API R&D, CCS and Manufacturing

Providing you the best range of API and Intermediate Manufacturing, Analytical Services and CCS & PRD with effective & timely delivery.

API and Intermediate Manufacturing
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R&D :
  • Developing non-infringing chemical processes for generic drugs and intermediates
  • Optimizing and validating the process at the lab, pilot and plant scale
  • Providing complete impurity profiles as required by competent regulatory bodies
  • Providing complete documentation for DMF filing
Manufacturing :
  • Manufacturing of generic API and key intermediate
  • State of the art manufacturing facility approved by US FDA, EDQM, PMDA, KFDA
  • Committed to quality, on time delivery, safety and environment

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Analytical Services
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Analytical Services

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At GVK BIO, we offer a range of Analytical Services from Discovery to Commercial Phase III. Our high quality services are ably supported by state-of-the-art instrumentation and cutting-edge technology. The Analytical Services portfolio includes:
  • Method Development and Validation
  • Stability Studies
  • Analytical Testing and Release
  • Structure Elucidation
  • GMP Separation
  • CMC Support

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CCS & PRD
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CCS & PRD

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GVK Biosciences offers CCS and PRD, contract manufacturing services, API and intermediate manufacturing, analytical services through its associate company- Inogent Laboratories. GVK BIO is engaged in providing Process Development & Custom Research and Manufacturing services for developing and synthesizing molecules; API and advanced Intermediates, from early development  (lab) to commercial launch (industrial scale) to meet the challenging manufacturing  needs of our pharmaceutical, cosmetic, electronic and fine chemical industry customers. Over the years we have acquired technical capabilities in scaling up complex chemical and biochemical processes. Our cGMP accredited pilot plant is fully equipped to develop intermediates and final products. Our Process Development team selects, develops and optimizes synthetic routes to provide our customers with cost-effective solutions, thus lowering the overall synthesis cost and time during scale up.

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