Part of US based
Semler Group of Companies,
in business since 1946


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Semler Research Center not only possesses the tools, expertise and assets to support our clients' ANDA submission efforts, we also have a strong commitment to optimize our operational costs and processes in a way that benefits our sponsors in bringing low-cost drugs to market faster and cheaper.

Our team of seasoned 'generic' specialists is adept at developing formulations to match Reference Listed Drug (RLD) specifications, combined with accurate analytical development and skilled technology transfer. We also undertake compilation of Complete Technical Document (CTD) dossiers, are familiar with electronic filing and can support our clients with regulatory global submissions for generic drug product approvals across the globe.

ANDA Service Highlights

  • Analytical development and validation based on ICH guidelines
  • RLD evaluation
  • Drug excipient interaction studies
  • Formulation development to match the dissolution properties of RLD in OGD and multimedia dissolution
  • Accelerated stability in primary pack along with RLD
  • Identification of critical process parameters and process optimization, and scale-up
  • Technology transfer
  • Bio-batch or exhibit batch manufacturing with strategic partners



About This Service

SRC offers top-notch scientific expertise across dosage forms and modes of administration. Our scientists have several decades of experience in developing products for US, EU, India, Brazilian, Turkish, South African & other markets across diverse therapeutic areas.