Shilpa Medicare Limited
Oncology Intermediates

Oncology Intermediates

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.

Oncology Intermediates

Purpose & What We Do

  • •Support the development and manufacture of intermediates used in oncology drug pipelines (payloads, linkers, reactive moieties)
  • •Ensure special handling, rapid development and scale-up aligned with tight timelines & high safety

Key Activities

  • •Synthesis of oncology-related intermediates with HP properties (cytotoxic, genotoxic etc.)
  • •Purification, impurity control especially for genotoxic / mutagenic impurities
  • •Stability / shelf life, degradation studies of intermediates
  • •Supply of sufficient quantities for late preclinical / early clinical conjugation or ADC assembly

Deliverables

  • •Oncology intermediate batches with required quality specifications
  • •Safety / Geno toxicity / impurity controls documentation
  • •Integration potential (linker, payload, antibody conjugation)

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