Shilpa Medicare Limited
cGMP Manufacturing

cGMP Manufacturing

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.

4. cGMP Manufacturing

Purpose & What We Do

  • •Deliver clinical-grade and commercial-grade HPAPI batches under full cGMP, following all regulatory guidelines
  • •Maintain consistency, compliance, safety, and traceability across production

Key Activities

  • •Use of dedicated HPAPI suites with isolator / barrier equipment, strict air handling, OEL level control. (Shilpa has 10 cGMP HPAPI suites capable of very low OELs < 0.01 µg/m³ for ADC payloads/payloads & linkers)
  • •Full documentation: batch records, quality control, cleaning validation, validation of process & analytical methods
  • •QC release: potency, purity, stability, residual solvents, heavy metals, impurity profiles, moisture etc.
  • •Packaging, containment, transportation in compliance with hazardous material standards

Deliverables

  • •cGMP HPAPI batches for Phase I / II / III and commercial use
  • •Regulatory ready dossiers (DMF / CEP / IND etc.)
  • •Full safety and compliance documentation

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