Seventy (70%) percent of our contract development and manufacturing services business is in generic drug product sector.
Halo Pharma has ongoing contract development and pharmaceutical manufacturing business relationships with 4 of the top 5 Global Generic companies including the manufacturing of multiple drug product families with several customers.
With an extensive and proven US regulatory track record, you can rest easy knowing your product will be manufactured to the highest quality standards and avoid the regulatory pitfalls exhibited by the many less experienced and “lowest cost” service providers.
Fifty (50%) of our generic development and manufacturing services come from repeat business. We have developed generic pharmaceuticals in multiple therapeutic areas but have very recent expertise and extensive experience in the development and manufacturing of controlled substances (CI-CV).
We provide our clients with prototype and pilot BE (bioequivalence) batches, pivotal BE batches and registration and commercial services. Our lean cost structure enables us to be very competitive with in-house pharmaceutical manufacturing.
We manufacture difficult to formulate drug products and provide bioavailability solutions to meet critical clinical endpoints.
Halo Pharma partners benefit from a single Project Team providing continuity as products progress through the following stages that include:
- Analytical Development, Transfer and Validation Activities
- Drug Development and Formulation Technical Transfer
- Manufacturing Non-GMP Laboratory Batches & Stability Programs
- QbD Optimization Batches
- cGMP Pilot Batches (Pharmacokinetics-Bio Batches)
- cGMP Pivotal Batches (Bioequivalence Batches)
We can provide turn-key solutions including assisting you in the sourcing of API and thus lessening the burden on you, letting you focus on sales and marketing and regulatory approvals.