Commercial Pharmaceutical Oral Liquids Manufacturing
Vici offers integrated pharmaceutical R&D and large-scale commercial manufacturing services for oral liquid pharmaceutical products. Both R&D and commercial manufacturing operations conveniently based in Maryland, USA.
Seamless R&D and Commercial Pharmaceutical Manufacturing
We can perform early-stage formulation development through process scale-up and commercial manufacturing with full regulatory filing support to provide a one-stop shop CDMO experience for our customers. Our highly qualified and trained technical and operations staff have years of experience developing and commercially manufacturing both NDA and ANDA oral solution and suspension pharmaceutical products. In addition, we can also develop and manufacture pharmaceutical products for-solution or for-suspension.
The commercial manufacturing facility is 54,000 sq ft and located in Maryland. The plant is equipped with a variety of modern manufacturing and packaging equipment to meet your oral liquid product manufacturing needs.
Oral liquid mixing tanks ranging from 150 liters to 1,500-liter capacity with further increase in capacity coming soon
A variety of mixing and homogenization capabilities to handle oral solutions and oral suspension products
Unit dose packaging machine for convenient oral liquid presentations suitable for patients on-the-go and in managed care facilities where the dose is administered by nursing staff
A full packaging line updated for serialization capability to fill bottles from 30 ml through over 500 ml
Certified for cGMP Manufacturing
The commercial manufacturing plant has a successful audit history with the US FDA and currently manufactures prescription branded and generic products for the US market. The plant operates under a robust quality management system to ensure cGMP compliance across all spheres of activity including sourcing, the warehouse, manufacturing, packaging, and quality control (QC) testing. An independent and experienced quality assurance (QA) team oversees all cGMP operations to ensure full compliance.
Quality Assurance and Quality Control
The QC laboratory, led and staffed by highly qualified chemists, is equipped with Waters HPLC running the latest version of Empower and is equipped with UPLCs for rapid throughput. Our QC lab is equipped with:
- Dissolution baths with auto samplers
- GCs
- Atomic absorption spectra capability
- Full range of ICH stability chambers for stability testing and establishing shelf life for pharmaceutical products
Our analytical chemistry team can fully develop, validate, and transfer all needed drug substance, excipient, and drug product release testing and stability testing methods.