Contract Pharmaceutical Manufacturing
CoreRx™ offers diversified technical resources, capacity, flexibility, and the experience to develop and manufacture virtually any clinical dosage form with strict quality compliance. We partner with you to provide expert scientific resources throughout the manufacturing process. CoreRx is not a large-scale, impersonal contract drug manufacturer. Instead we focus on full pharmaceutical development support for customers with small-scale manufacturing needs. Our commitment to flexibility, expertise, communication, and value will keep your pharmaceutical manufacturing project on time and on budget.
Strict Quality Control & Collaborative Services
At CoreRx, our goal is to move quickly and efficiently from clinical development into cGMP manufacturing. Throughout the manufacturing process, scientists continue to monitor and analyze results to ensure that your drug product is delivered according to specifications and regulations. A full range of pharmaceutical manufacturing services are ready to meet the demands of your project.
Full cGMP compliance, accountability and document traceability
cGMP compliant contract drug manufacturing services are available for any dosage form including combination products, solids, liquids, semi-solids, and topical. Compliant with Title 21 CFR part 11, all data 100% inspected and quality audited to ensure full manufacturing compliance.
Packaging and labeling of various dosage forms
We have the ability to package and label products in a variety of packaging including blisters packs, bottles, and tubes.
Process development, scale-up, technical transfer
Manufacturing process development experience ensures effective scale up from less than 1kg to multi-kilo batches, and transfer of manufacturing processes to client.
Manufacture matching placebo for clinical studies
In support of blinded clinical studies, CoreRx provides batch manufacturing of placebo matching the appearance of active containing batches.
Process qualification, cleaning verification
CoreRx follows the FDA guidance and incorporates appropriate elements of process validation for the manufacture of human and animal drug products. Additionally, cleaning verification studies are conducted and fully documented for each contract manufacturing project.
Optimizing process operations
Improving the process for manufacturing the dosage forms, especially with oral solids involves manipulation of particle size of active, as well as excipients. While larger particles flow well, smaller particles improve dissolution and absorption.
Innovative contract drug manufacturing capabilities for challenging products
Our facilities have the ability to manufacture unique delivery forms such as bi-layer, tri-layer tablets, as well as thin film strips for oral delivery. We have unique expertise with modified and controlled release, in addition to taste masking of bitter compounds. Capabilities also include potent compound pharmaceutical manufacturing and DEA controlled drugs.
Ability to customize manufacturing to client demands
From drug development to manufacturing and packaging of clinical supplies, CoreRx keeps open scientific communication to ensure that every client need is met. Whether it is dosage aesthetics, special packaging requirements, or fast-track timelines, CoreRx will meet and exceed your expectations.