Elite Pharmaceuticals, Inc. is a leading specialty pharmaceutical company focused on developing and manufacturing oral, controlled-release drug products. Leveraging proprietary technologies, Elite creates high-barrier generic pharmaceuticals to address complex therapeutic needs. Elite maintains a strong foothold in the generic pharmaceutical industry with a portfolio that includes multiple generic products, some licensed to Prasco, LLC and TAGI Pharma.
Operating from a cGMP and DEA-registered facility in Northvale, NJ, Elite Pharmaceuticals is committed to upholding the highest quality standards. The company meets rigorous FDA regulations, ensuring excellence in every stage of product development and manufacturing. Known for its innovation and regulatory expertise, Elite Pharmaceuticals continues to serve both domestic and international markets with its broad range of oral solids and semi-solid dosage forms.
Challenges
Elite Pharmaceuticals faced significant hurdles with their existing methods of stability data management, resulting in operational inefficiencies. Key challenges included:
- Manual data tracking: Inconsistent and time-consuming manual processes for stability testing and reporting.
- Data fragmentation: Difficulty in consolidating stability data from multiple sources across departments, hindering accurate decision-making.
- Compliance management: Struggles to maintain adherence to global regulatory requirements and standards due to disparate systems.
- Audit inefficiencies: Lengthy manual processes led to delays and inefficiencies during regulatory audits and inspections.
To learn how Elite Pharmaceuticals overcame these challenges with the implementation of a robust Stability Management System, fill out the form below to download the full case study!
Industry
Pharmaceutical Manufacturing
Location,
USA
Employees,
65+
Where is your business office?
In the India locations.
Time for deliveryÂ
35 days
What do you want us to do in this ?
We will assure our best services. In this time and in case of any need we will be there for you.Â
