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Contract cGMP-API Manufacturing:
We have the experience and resources to meet all of your Active Pharmaceutical Ingredient (API) requirements. We support all facets of chemistry manufacturing and controls (CMC) preparation related to APIs, including structure elucidation, specifications development, methods validation, drug substance stability as well as preparation of documentation for submission.
Our manufacturing facility in Riverview, Michigan includes pilot plant and commercial scale glass-lined vessels with volumes ranging from 10 to 500 gallons and operating temperatures ranging from –80° to 200°C. Our isolation and purification technologies include extraction, filtration, centrifugation, barrier isolation systems (highly-potent or air-sensitive compounds) and distillation. Drying and finish equipment includes a variety of forced air and drying ovens, as well as class 10,000 (M5.5) clean suites.
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