Dipharma Inc.
4502 Campus Drive
Kalamazoo, MI 49008 USA
Tel. +1 269 488-8488

Dipharma Inc. is a world-class chemistry Contract Development and Manufacturing Organization (CDMO), whose scientists average 15 years’ experience in pharmaceutical development, from lead optimization through process development for clinical development. Its cGMP Kilolab and QC Laboratories manage supply for clinical Phase 1 and early Phase 2 deliveries. Dipharma Inc. also offers an outstanding CRO experience for your challenging synthetic projects. It provides process route development, analytical development, custom synthesis (including stable label), and process impurity synthesis to Dipharma Group clients world-wide.

Compliance status

Fully cGMP compliant Quality System

  • 2020 cGMP, FDA registered
    FEI: 3004853226
    DUNS: 028683144
  • 2024 US FDA inspection

Plant hardware

Dipharma Inc.’s laboratories occupy a total area of about 22,000 square feet, 2044 square meters. The laboratories are divided into R&D and GMP areas. The equipment for each of these areas is given below.

In house R&D

Dipharma Inc.’s R&D Laboratory has a state-of-the-art complement of instrumentation and equipment.  This includes:

  • 400 and 300 MHz NMRs, with auto-samplers and variable temperature
  • Multiple nuclei probe for 1H, 19F, 13C, 14N, 31P etc.
  • Multiple HPLC units, including UV-Vis, ELSD, and CAD detectors
  • Seven preparative chromatography systems (CombiFlash abd Biotage) including ELSD and reverse-phase prep capability
  • Two walk-up LC/MS spectrometers
  • Two GC systems with headspace and direct injection capabilities
  • KF titrator
  • Access to CHN, ROI, LOD, Exact Mass
  • Electronic Notebook system
  • Two 15 liter reactors
    • Temperature range of -60 to 200 °C
    • Working pressure range of full vacuum to ambient pressure
  • One 50 Liter reactor
    • Temperature range of -60 to 200 °C
    • Working pressure range of full vacuum to ambient pressure
  • One 20 liter jacketed nutsch filter
  • Labconco benchtop lyophilizers (2 units)
    • Approximately 2 L capacity
  • Parr hydrogenators
    • 500 mL Shakers (2 units)
    • 5 L Shaker
  • Parr high pressure reactor vessels
    • 2 L Hastelloy® vessel rated to 3000 psi @ 500 °C
    • 8 L Hastelloy® vessel rated to 2000 psi @ 22 °C
    • Several smaller vessels made of SS
  • Ozone generator
  • CEM Discover Microwave reactor

cGMP Kilolab

  • Wet chemistry Line
    • 30 L (2) mobile reactors with walk-in hoods for up to 5 kg output (chemistry dependent)
    • Temp ranges -60 C to 200 °C

Dedicated teams to support the development for custom synthesis API projects; including analytical development, Quality Control support, and a fully-compliant Quality Management System.

Visitors information

Dipharma Inc. is located in a state of the art facility in the Western Michigan University
Business Technology Research Park in Kalamazoo Michigan – US

To view our site location or find directions to our site, you can visit the Google Maps Page.

GPS coordinates
N 42° 15′ 26″ W 85° 38′ 22″

Hotels with corporate agreement
Please contact us for any assistance with booking, and to benefit from our corporate rates.

Locations
More about our sites

Dipharma Baranzate
Headquarters and production site

Dipharma Francis S.r.l.
Via Bissone, 5
20021 Baranzate (MI) – Italy
T + 39 02 38228.1
F +39 02 38201075

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Dipharma Caronno
Production site

Dipharma Francis S.r.l.
Via Origgio, 23
21042 Caronno Pertusella (VA) – Italy
T + 39 02 96440.1
F +39 02 96440599

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Dipharma Mereto
Production site

Dipharma Francis S.r.l.
Via XXIV Maggio, 40
33036 Mereto di Tomba (UD) – Italy
T + 39 0432 866711
F +39 0432 865072

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Dipharma China
Beijing Repr. Office

Dipharma Francis S.r.l.
Room 527 Building 6
No. 9 in Fangyuan Nanli
Chaoyang District
100016 Beijing, China
T +86 10 64376931