Drug Substance

Drug Substance
Product Description

BioDuro-Sundia’s Drug Substance manufacturing services support production of small molecule APIs, RSMs and intermediates--both GMP and non-GMP .  We provide a full range of production scale, supporting all stages of drug substance development through IND submission.  Fully integrated CMC services boasts a proven track record of over 100 clients. With over 20 IND & Generic DMF Filings, our team has deep experience in complex Sugar Chemistry & heterocyclic compound manufacturing.
Facility Overview

  • Manufacturing facilities & storage – 20,000 ft2²
  • Capability of wastewater disposal: 50 tons/day
  • Utility: Saline water cooling, compressed air, soft water
  • 120 research fume hoods in Process Lab
  • Non GMP kilo scale lab: 17 reactors from 50 – 100L
  • cGMP kilo lab: 5 reactors from 100 – 200L
  • Temp reaction capability: 800C℃ – 2300C℃
  • Pressure reaction upto 1mPa (120 psi)
  • Clean room for API production
  • Non-GMP pilot plant with 20 reactors from 300L – 5000L
  • Chromatography column/Separation System: DAC 150 & DAC 300

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BioDuro

  • Country/Region:
    United States
  • Founded:
    1996
  • On CPHI since:
    2018
  • Certificates:
    2
  • Employees:
    1000 - 4999
Company types
Contract Service
View company profile
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BioDuro

  • Country/Region:
    United States
  • Founded:
    1996
  • On CPHI since:
    2018
  • Certificates:
    2
  • Employees:
    1000 - 4999
Company types
Contract Service
View company profile

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