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

Kalexsyn is a world-class chemistry Contract Development Manufacturing Organization (CDMO), whose scientists average 15 years’ experience in hit validation, lead optimization and solving tough synthetic problems. Its cGMP Kilolab and QC Laboratory manage supply for clinical Phase 1 and early Phase 2. On top of this, the Company offers an outstanding CRO experience with fixed quote as well as short and long-term FTE arrangements. It provides stable label synthesis, custom synthesis, process impurity synthesis, and process route development to Dipharma Group world-wide clients.

Compliance status

Fully cGMP compliant Quality System

  • 2020 cGMP, FDA registered
    FEI: 3004853226
    DUNS: 137538224

Plant hardware

Kalexsyn’s laboratories occupy a total area of about 1858 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

Kalexsyn’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 ion probe H, F, C, N, P etc.
  • Multiple Agilent 1100 HPLC units
  • Seven preparative chromatography systems (CombiFlash abd Biotage) including ELSD and reverse-phase prep capability
  • Two walk-up LC/MS spectrometers
  • Two GC systems
  • 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

cGMP Kilolab

  • 2020 cGMP, FDA registered

FEI: 3004853226

DUNS: 137538224

  • Wet chemistry Line
  • 30 L (2) mobile reactors with walk-in hoods for up to 10 kg output (chemistry dependent)
  • Temp ranges -40 C to 200 °C

Dedicated teams to support the wet line with development for custom synthesis API projects

Visitors information

Kalexsyn 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

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

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

Dipharma Inc.

4502 Campus Drive
Kalamazoo, MI 49008, USA
T +1 269 488 8239
F +1 269 488 8490

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