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'Product Blog'

Providing Reliable cGMP Solutions for over 30 years

cGMP & Custom Synthesis

We deliver consistent quality and expertise in cGMP and custom synthesis production. All chemists at our Newburyport site are regularly trained on GMP standards and participate in GMP production to provide customers with reliable products and services.

cGMP Production

Custom synthesis services and process development are conducted under the strictest confidence. A broad range of chemical transformations are possible at our Newburyport facility. For pharmaceutical applications, manufacturing is conducted under current Good Manufacturing Practices (cGMP) in kilo-lab suites. This capability has been available at the Newburyport site since 1988. Complete documentation is provided, including validation and stability studies. Both Active Pharmaceutical Ingredients (APIs) and late stage raw materials for APIs are manufactured. Active Drug Master Files (DMFs) are also maintained in North America and Europe. Quality agreements are in place with major US and International drug companies.

Current APIs

  • Cisplatin
  • Carboplatin
  • Dexmedetomidine HCI*
  • Isoproterenol HCI*
  • Selenious Acid**
  • Cupric Sulfate Pentahydrate
  • Chromic Chloride
  • Pamidronic Acid*
  • Sodium Sulfide Nanohydrate

*Marketed exclusively through Chemwerth
**Available through Chemwerth if a DMF is required

Contact us today to learn more!



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