Science Based Organization
Lab Express International is a science based organization focused in developing Rx & OTC products in the forms of liquids, solids and topical products for sample distribution or commercialization. We succeed in all aspects of R&D, while providing our clients with products which comply with FDA cGMP/ICH requirements. Validation programs are in place for all products that are manufactured within our US FDA facility. Should you require a pilot batch for non-commercial or commercial use , we can meet your needs by offering a customized package for both product development and manufacturing in one location. The main focus within our R&D Department is continuing to take on product development projects that are complex and are offered under licensing/exclusivity agreements with long-term profit sustainability’s
We continue to invest in resources/equipment and personnel in order to better serve our customers. Moreover, we continue to offer new and existing formulas so that our customers can benefit in diversifying their product portfolio and further increase their sales, on niche products (NDA’s/ANDA’s/ OTC’s).
Product Development, Rx & OTC Service Offerings
Below are some of our services we offer within Product Development, Rx & OTC:
- Formulation Development Pilot Batches (Commercial or Non-Commercial)
- Accelerated, Intermediate and Long-Term Stability Studies (ICH Guidelines) in validated temperature mapped and calibrated chambers
- Stability Protocols
- Complete Release Testing for pilot and commercial size batches
- Product Development for NDA’s / ANDA’s / OTC’s
- Product Development for Liquids, Solids & Topical Creams and Lotions
- Process & Cleaning Validations
- Protocols for execution
- NDA & ANDA Submission Filings
- USDMF products
Liquid & Topical Dose Manufacturing
Lab Express International offers in-house liquid & topical dose manufacturing. We operate in a productive manner and continue increasing our production capacities to meet market/customer demands. We are committed to excellence in quality, regulatory and customer experiences. The Lab Express team is committed to making sure that our customers receive attention and solutions to their complex processes/products. Additionally our products are developed utilizing our validated USP Purified Water System, hot and cold mixtures and environmental controlled storage of components. We also provide in house quality laboratory capabilities with HPLC, FT-IR, UV-VIS, TLC, Analytical Balances, Specific Gravity, Melting Point, Viscosity testing, pH, Conductivity instruments.
Lab Express International conducts business with a pharmaceutical regulatory mindset. Many of our employees are from big Pharma with up to 30 + years in the industry and have developed and have US patented pharmaceutical products. Our core business is quality API and finished products, helping our customer to market will excellence and speed. We assure FDA requirements are followed and implemented for all products released from our facility.
We understand the importance of being able to obtain a fast quotation. Our Sales/Marketing staff is highly trained and knowledgeable so that complex processes are simplified for our customers. Our network of suppliers/vendors and component manufacturers gives us the opportunity to provide quick turnarounds on RFP’s.
Our minimum quantities are small to pilot batch and may vary on a project basis. No project is considered too small or too large. Our job is to perform the due diligence required and making the correct determinations on our customer future needs.
Liquid Dose Batch Size Availabilities and Equipment Capacities:
- Fully Automated Liquid Lines can fill 5ML, 10ML, 50 ML 1L, 4L, 1 gallon, 5 gallon and 55 gallons
- Liquid Manufacturing Tanks of 350, 500, 3000, & 5200 kg and coming soon 10,000 KG batches
- Current equipment can be used to manufacture solutions as well as solid-containing suspensions
- 2 GMP Suites and 4 more being built in 2015
Topical Cremes/lotion Dose Batch Size Availabilities:
- Our mixing tanks are 350 kg, 500kg, 1000 kg & 5200 kg
- Container Tube size filling availabilities: 2 oz, 4 oz, 6 oz
- 2 GMP Suites with 4 more under construction