Our capabilities

Development and formulation

We offer the technical capability, skill and experience to perform rigorous evaluations of your drug candidates.

Working as your partner, we ensure your candidates’ compatibility with the InstaPill™ platform and help to develop efficient, robust processes and analytical approaches that ensure you have the data you need to successfully commercialize the right products.

Our offering includes:

  • Screening and identification of drug candidates for the proof-of-concept (POC) studies.
  • Support for extensive pre-formulation studies like API solubility study, solid state characterization including compatibility studies.
  • API and formulation characterization via expert analysis and data interpretation throughout the development cycle and support for regulatory filings.
  • In-house analytical and regulatory services.
  • Clinical capability for designing strategies related to various bio studies.
  • Stability data generation.
  • Clinical studies (bioequivalence, bioavailability).
  • Human taste assessment.
  • Full turnkey product/brand LCM from prototype development.
  • Capability to develop a robust product and process technology using QBD, DoE principles.

Lyophilization

Our specialists can help you formulate a lyophilized ODT with effective task masking, which is either equivalent or superior to conventional ODT performance (with dose up to 200 mg for insoluble APIs and 20 mg for soluble APIs).

Our facilities are equipped with the latest models of lyophilizers at different working ranges from lab and pilot scale to commercial scale.

Our team has expertise in optimizing lyophilization cycles using advanced technologies, helping to reduce the cost of manufacturing and providing lyophilized RDTs at a more affordable price.

This means you can successfully commercialize lyophilized RDTs with advanced taste-masking and flavor-enhancing techniques.

Manufacturing

From our state-of-the-art manufacturing facility in India, InstaPill™ offers highly automated operations to improve speed, accuracy, and quality to ensure dosage uniformity and precision.

Our capacity allows us to scale-up for our partners and produce approximately 270 million rapid dissolve tablets annually, ensuring consistent supply.

Our facilities:

Bengaluru development

  • R&D center.
  • Expertise in clinical affairs, regulatory and analytical capabilities.
  • Lab and exhibit-scale manufacturing and scale-up including clinical supply.
  • Approved by various regulatory agencies including FDA, EMA, Health Canada and TGA.

Bengaluru manufacturing

  • 21 CFR Part 11 compliant line with global serialization requirements incorporated, adaptable to e-batch record manufacturing.
  • Capacity to produce 270 million RDTs annually.
  • Integrated end to end line – from base foil introduction to case-package collection.
  • Extensive automation to provide high cGMP compliance.
  • Auto Guided Vehicle (AGV) system introduced for loading and unloading of blister tray to/from Lyophilizer.
  • Approved by various regulatory agencies including FDA, EMA, Health Canada and TGA.