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With over decades of experience, Aurigene Pharmaceutical Services specializes in manufacturing of High Potent Active Pharmaceutical Ingredients (HPAPI) (up to OEL 0.1 µg/m³). We offer HPAPI products manufactured in our FDA-approved cGMP API manufacturing facilities with comprehensive containment processes and strict QC/QA.

Why Aurigene Pharmaceutical Services?

OEB level 5 (OEL as low as 0.1 µg/m³)

OEB level 5
(OEL as low as 0.1 µg/m³)

+50 APIs Manufactured

+50 APIs
Manufactured

+200 High Potent Steps

+200 High
Potent Steps

5 Facilities Across 3 Continents

5 Facilities
Across 3 Continents

 

We have the capability to handling potent compounds inclusive of cytotoxic, backed by special unit operation capable of micronization and spray drying. Our facility is designed to give an output as low as 500 gm to multi-tons.

Infrastructure to support HPAPI manufacturing

  • Multipurpose facility with reactors
  • Isolator technology in place for containment to handle OEB 5 compounds
  • Haestelloy ANFD with isolator
  • Facility for milling, blending and packing under isolation techniques with isolators
  • Analytical instruments (HPLCs, GC, FTIR, UV-Vis, polarimeter & microbiology laboratory)
  • Cleaning-in-place (CIP) practiced under closed condition
  • Separate effluent detoxification reactor
  • Isolator technology in place for containment

Aurigene Pharmaceutical Services is

a leading CRO/CDMO

providing research and manufacturing services

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