manufacturing@nastech.com

Nastech has fully validated and FDA approved manufacturing operations in both its Bothell, Washington location and in Hauppauge, New York. The manufacturing operations support Nastech’s development efforts, as well as contract manufacturing for our partners and other pharmaceutical companies.

Manufacturing Expertise:

Nastech has invested substantial time, money and intellectual capital in developing our manufacturing facilities and know-how. We have a dedicated and flexible manufacturing team with the ability to fast-track projects. These capabilities are available to give you a competitive advantage for your products.

• 2 FDA licensed facilities providing clinical or
  commercial production
• DEA approved
• Schedule II and Schedule IV Research licenses
• Schedule II Manufacturing license
• Liquid filling capability from 0.5 ml to 100 ml
• Clinical supplies or full commercial production
• Secondary packaging operations
• Contact and contracts with leading suppliers of active pharmaceutical ingredients, excipients, and
  packaging components
• Special expertise in nasal sprays and gels

Quality Assurance and Control Expertise

Nastech’s quality systems maintain a high level of quality assurance and quality control for both the manufacturing and development processes. Our systems and facilities have been audited and approved by the FDA, various European agencies, and numerous partner pharmaceutical companies (U.S. and international). Nastech’s capabilities include:

• Raw material and finished product testing
• Methods development
• Change management and impact assessment
• Full stability programs