GMP API Manufacturing

A Global Network for Integrated Manufacturing Solutions

Renowned in the industry for the flexibility and innovation of our processes, J-STAR can scale our chemistries to handle quantities from milligram to multi-kilos, with capabilities including the manufacture of intermediates and impurities, reference standards, non-GMP APIs and raw materials.

For volume exceeding the capacity of our NJ facilities, we can also leverage our parent company (Porton) to support larger scales spanning to commercial capacity.

non-gmp

Non-GMP Labs

J-STAR Research has the ability to rapidly scale production from milligram to multi-kilo quantities. In the event that requirement exceeds our capacities, we also have the flexibility of leveraging the production facilities of our parent company Porton, Inc, one of the world’s leaders in the manufacturing of pharmaceutical intermediates and APIs.

GMP labs

GMP labs

Once a practical synthetic route has been demonstrated and the critical process research required for scale-up has been performed, J-STAR can then provide API prepared under cGMP guidelines to support Phase I human clinical trials. This is typically done after supplying material for GLP toxicology studies.

GMP Quality Assurance

GMP Quality Assurance

The J-STAR Research GMP Quality Assurance team has over 45 years collective experience with GMP systems for the manufacture, testing, and release of APIs for use in clinical trials. GMP operations at J-STAR Research are carried out in compliance with the Q7 guidance, as it pertains to APIs for use in clinical trials.

Potent and High Potent Capabilities

Potent and High Potent Capabilities

Our state-of-the-art facility can help meet the needs of your high potency development programs as our subject matter experts ensure that we will handle your API programs with the highest level of care and safety to ensure success.

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J-STAR Research helps pharmaceutical small molecule R&D programs succeed in all phases of development.