Cambrex

1 Meadowlands Plaza
East Rutherford, NJ, 07073
T: 201-804-3000
E: info@cambrex.com
Twitter: twitter.com/cambrex
LinkedIn: linkedin.com/company/cambrex/
Website: www.cambrex.com
Number of employees: 1,650
Year established: 1981

Cambrex is the leading small molecule company that provides drug substance and drug product services across the entire drug lifecycle. Driven by passion, our pharmaceutical products, expertise and technologies accelerate our customers’ small molecule therapeutics into markets across the world.

 

 

 

  • We put all of our energy and experience into being your partner of choice
  • We create value for customers through manufacturing excellence, reliable quality and innovative science
  • Our people are the experts that our customers enjoy working with

We truly offer our customers an end-to-end partnership for the research, development and manufacture of small molecule therapeutics at every stage of the drug lifecycle.

TECHNICAL SERVICES

 Drug substance development and manufacturing expertise in:

  • Route selection
  • Process development and optimization
  • Contract process research
  • Analytical development and validation
  • Synthesis and purification of analytical reference standards
  • ICH stability studies
  • Safety and toxicology assessments
  • Controlled substances R&D and manufacturing
  • Process and analytical validation
  • Lab, kilo and pilot scale manufacturing for pre-clinical studies and all phases of clinical trials – supplying mg to kilogram quantities
  • Commercial manufacturing for product launch and in-market supply for kilogram to 100+MT quantities
  • Quality Assurance and Quality Control
  • Regulatory support and filings
  • Leading range of more than 100 generic APIs; 90 of which are commercially sold and free from patent with 90 DMFs filed globally
  • Support for NDAs and 505(b)(2) NDAs for existing APIs
  • Commercial scale cGMP manufacturing

Drug product development and manufacturing expertise in: 

  • Controlled substances (DEA Schedule I-V)
  • Extended/modified release tablets/capsules
  • Hot-melt extrusion
  • Extrusion/spheronization
  • Sustained release beads
  • Micro and mini tablets
  • Fixed-dose combination tablets
  • Bi-layer tablets
  • Film-coated tablets
  • Solvent-based formulations
  • Powders
  • Liquids
  • Creams
  • Non-sterile ointments
  • Sterile ointments
  • Suppositories

MAJOR PRODUCTS/SERVICES

Drug substance services: 

  • Custom development
  • Custom manufacturing
  • Generic APIs

 Drug product services:

  • Formulation development
  • Clinical supply
  • Custom manufacturing
  • Packaging
  • Analytical services

Specialist technologies include enzymatic biotransformations, high potency APIs, high energy chemical synthesis, controlled substances, hot melt extrusion, fixed-dose combinations and continuous processing.

FACILITIES

Cambrex has a presence in nine locations globally, which include:

  • Headquarters in East Rutherford, NJ, USA
  • Drug substance facilities in Charles City, Iowa, USA, High Point, North Carolina, USA, Karlskoga, Sweden, Paullo (Milan), Italy, Tallinn, Estonia and Wiesbaden, Germany
  • Drug product facilities in Whippany, NJ, USA and Mirabel, Montreal, Canada