How do I scale up my product for commercial launch?
Quotient is your answer.
Our commercial batch size capabilities include:
- Up to 500kg for solid oral dosage forms
- Up to 350L for liquid formats using an automated filling line
In addition to manufacturing products for NDA, ANDA, MAA and JNDA registration, the Quotient team can support 505(b)(2) and CBE-30 filings.
Process validation and registration batches
Whether you are preparing for NDA, MAA or Japanese NDA, Quotient has the expertise and regulatory approval to manufacture your validation and registration batches for the U.S., U.K., Europe and Japan.
Phase III and commercial drug product supply
Quotient can support all aspects of your drug product supply for Phase III clinical studies and commercial supply.
- Manufacture of all oral drug product dosage forms in our FDA-, EU- and PDA- approved facilities
- Packaging including bottles, blisters, tubs or tubes
Quotient has vast experience across an array of dosage forms that we manufacture for registration and commercial supply, including:
- Solid oral dosage forms
- Oral solutions and suspensions
High-potency API handling
Using our experience across the industry pipeline, Quotient has responded to the challenges associated with the manufacturing of today’s high-potency drug products by ensuring our facilities are capable of handling compounds with a maximum performance-based level of exposure classification.
When you need commercial manufacturing for a simple or complex drug product, Quotient is your answer.
Global formulation development and manufacturing capabilities
We provide full service support for small molecule non-sterile programs, from dosage formulation development through to GMP clinical trial manufacturing and commercial drug product supply.
We offer commercial manufacturing of small molecule products including niche therapies like oncology, orphan and pediatric indications.
Breathing new life into Phase 1 trials. Quotient's approach is helping Pulmatrix to develop a range of inhaled dry powder chemical entities based on its iSPERSE™ technology to meet unmet medical needs in multiple respiratory diseases.
An accelerated approach to clinical trials. Corcept Therapeutics is developing CORT125134, a promising candidate for the treatment of Cushing’s syndrome, a rare disorder associated with significant morbidity and mortality.