C GMP
Ascensus delivers consistent quality and expertise in cGMP and custom synthesis production. All chemists at the 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.

Site Capabilities

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GMP Suites & Facilities
  • 3 ISO Class 7 rooms
  • 2 controlled, nonclassified GMP rooms
  • Dedicated glassware
  • Dedicated production suite
  • Verified Line Clearance prior to project change-over
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Equipment & Scale
  • Kilo-lab production Up to 22L dedicated glassware
  • Capable of 50-75L
  • Expansion capacity (150L)
  • 10s to few 100s of kilos of API
  • Cryogenic (down to -78°C)
  • Max temperature 265°C
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Analytical Support
  • Method Development
  • Methods Transfer
  • Methods Verification/Validation
  • Data Integrity
  • Release and Stability Testing
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Cleaning
  • Dedicated glassware
  • Cleaning SOPs
    • Rinse release
    • Depyrogenated
    • Swab-released
  • Cleaning Validation

Current APIs

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

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

Inquiries for additional products are accepted - please contact our team using the form below.

With Ascensus you are choosing more than the best product, you’re choosing a partner.

We are equipped to customize a solution and support you every step of the way–from applications development and field evaluation to startup, ongoing assistance and troubleshooting, we are committed to you.

Contact us today.

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