Range of Product Manufacturing Requirements
Product and Process Development
Pre-Ind Clinical Manufacturing: For animal toxicity studes, For chemical stability studies, Typical batch size up to 1,000 units
IND Phase I: For efficacy testing, For dosage-range finding, For human safety studies, For drug stability studies Typical batch size up to 5,000 units
IND Phase II: For expanded clinical studies, For investigation of specialized delivery systems, For finalization of dosage form for market, Typical batch size up to 10,000 units
IND Phase III: For expanded clinical studies, For final development of label claims, For final development of contraindications, For additional supplies required for compassionate use, For process validation, Typical batch size up to 100,000 units
NDA Submission
Ben Venue Laboratories is the only source for the US that can provide the complete range of product manufacturing requirements from development through commercial manufacturing for both liquid and lyophilized products.
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