Shilpa Medicare Limited
Route Scouting

Route Scouting

Specialized infrastructure & expert teams for safe, compliant development & manufacture of high-potency APIs, including for oncology.

Overview

We provide end-to-end HPAPI services from early route identification through commercial-scale cGMP supply. Our facilities include multiple dedicated HPAPI suites (OEL / OEB compliance), isolator technology, enriched analytical lab support, and a robust payload/linker library. We support both oncology & non-oncology high potency compounds.

Specialized infrastructure & expert teams for safe, compliant development & manufacture of high-potency APIs

Including for oncology

Overview

We provide end-to-end HPAPI services from early route identification through commercial-scale cGMP supply. Our facilities include multiple dedicated HPAPI suites (OEL / OEB compliance), isolator technology, enriched analytical lab support, and a robust payload/linker library. We support both oncology & non-oncology high potency compounds.

Capabilities Summary

Fully contained dedicated HPAPI blocks with isolator / barrier containment for safe handling of very low occupational exposure limits (e.g., OEL / OEB Bands 1-5). Extensive experience with oncology intermediates, payloads, linkers, and cytotoxic compounds. Analytical labs specialized for HPAPI impurity control, particle size, residual solvents, stability, and potency. Scalable manufacturing: gram scale → clinical → commercial, with certified clean rooms, multiple dedicated blocks.

1. Route Scouting

Purpose & What We Do

  • •Identify synthetic routes (starting materials → intermediates → final HPAPI) that maximize yield, safety, cost-effectiveness, and minimize hazardous reagents
  • •Evaluate multiple potential pathways including alternative reagents, greener chemistry, fewer steps, and minimal waste
  • •Initial reaction screening: batch studies, microscopy, small-scale hazard assessment
  • •Feasibility for scale-up in terms of reaction kinetics, mixing, heat load, exotherms

Key Activities

  • •Collection of literature / patent review for route ideas
  • •Lab-scale reaction trials in controlled environments (mg → g scale)
  • •Hazard / safety review of reagents and reagents carry-over
  • •Preliminary impurity profile estimation

Feasibility & Commercial Assessment

  • •Alternative synthetic route design
  • •Cost-of-goods modelling
  • •Raw material sourcing assessment
  • •Intellectual property landscape review

Deliverables

  • •Route comparison dossiers (pros/cons, yields, safety, cost)
  • •Preliminary risk assessment (chemicals, thermal hazards)
  • •Workflows for selected route(s) for further development

Route Scouting at Raichur, Karnataka

Route scouting and feasibility work is carried out at Shilpa Medicare's Raichur, Karnataka facilities, part of a small-molecule CDMO platform spanning approximately 1,160 KL of reactor capacity across 21 blocks, including nine dedicated high-containment blocks engineered to OEL-4.