Quality & compliance

Assuring quality and compliance

Rethinking generics means setting higher standards.

At our Norwich, New York manufacturing headquarters, Alvogen successfully meets – and often exceeds – quality and compliance requirements.

Customer-Centric-Packaging

Our quality requirements

Our commitment to quality is comprehensive and includes:

  • Unparalleled regulatory compliance history – including a 20-year compliance record with no FDA-483 citations
  • Continuous improvement philosophy
  • Ongoing self and customer auditing to help ensure a compliant state is maintained
  • Training systems for all aspects of the business
  • Stringent SOP management ensures compliance
  • Extensive measurement and tracking systems to ensure on-time performance

In addition, we provide full service Quality Assurance/Quality Control capability, including:

  • Analytical and Microbiological Laboratories provide raw material, packaging component, chemical intermediate and finished product testing services to the production operation.
  • The Stability Services Group provides sample storage, full testing, statistical analysis and report writing capability to customers who need support up to and including the requirements of ICH.
  • The Quality Systems Organization provides validation, change control, production support, documentation control, and other cGMP services to the plant and to our customers.

International compliance and quality assurance

Product

Alvogen also has access to first-class regulatory, development and manufacturing capabilities in Asia and Europe. We set high standards in quality, strong compliance systems and dependable on-time delivery. 

Beginning with our strict R&D guidelines and continuing right through until our products hit your shelves, you can count on receiving only high quality products and services, on time, every time.

Connect with Alvogen Americas

Would you like to learn more about our portfolio, business development, or do you have an idea for partnership or future collaboration? We would like to hear from you.