> Making generic solid dosage products at the same address since 1983
> Site acquired by Prinston in 2017
> FDA and DEA licensed
> State of the art Quality Systems
> Experienced management team
> Cost efficient operations with focus on On-Time In-Full delivery
Prinston Labs uses major brand name equipment. Large batch products are our specialty.
> Kikusui and Korsch tablet presses
> Bosch encapsulation
> Vector & Glatt fluid bed granulators
> Optel serialization equipment
Prinston Laboratory's employees come from diverse backgrounds and nationalities. Team Leads and Senior staff are true subject matter experts. Strong interpersonal relationships help the workplace foster a strong teamwork and can-do attitude. Quality focus is passed from generation to generation of employees. Potential roadblocks are tossed aside as together we achieve the goals.
Speaking of generational Quality focus, the Charlotte QC team has performed 100% on-time stability tests continuously since the 1990's, continuing excellent work through 4 changes of ownership and numerous changes in lab management. Under Prinston's ownership, this focus continues with new investments in lab equipment, data management and optimization of QC methods.
Safety and Hygiene
Working safely is the prerequisite. Typical annual safety metrics would produce a recordable incident rate of less than 1.0 with a lost time incident rate of 0.0. Regarding COVID-19, our site has remained open every day. Our sanitization and preventative measures have proven effective. Very few employees have missed work due to the virus, and there have been no cases of workplace transmission in 2020.
Quality Assurance and Regulatory Compliance
Prinston Laboratories has an excellent record of regulatory compliance. Under the Prinston ownership, the site has seen multiple US FDA general and pre-approval inspections with no 483 citations. Excellent compliance history is maintained with various other local, state and federal agencies including the DEA.
Well proven software systems help manage compliance. Systems provided by SAP, Sparta Systems, StarLIMS, Blue Mountain, Master Control, Eduneering, etc. document everything from training and change controls to batch progress, laboratory data and inventory.
Services for You
Prinston Laboratories offers Contract Manufacturing Services (CMO) tailored to fit your needs. Oral solid dosage batches from a minimum size of 85kg on up to 1800 kg, or as little as 160,000 doses to over 20,000,000 doses per batch.
With our focus on cost competitiveness and on-time delivery, and our convenient location near the intersection of I-77 and I-85 barely 10 minutes from the Charlotte Douglas International Airport, we can help you solve your supply problems. To discuss farther, please email us at CMOServices@prinstonpharm.com