Sterile Drug Dosage Forms

We understand the unique challenges of sterile injectable development and offer a broad range of capabilities to address the specific needs of your drug product, including:

  • Small-volume parenterals
  • Large-volume parenterals
  • Liquid filled vials
  • Lyophilized vials
  • An extensive range of vial sizes including ISO standard vials
  • Pre-filled syringes
  • Pre-filled cartridges

Why Choose Us

Flexibility, speed, expertise, and experience are needed to advance your sterile injectables drug product from the pre-clinical phase to approval. Patheon, part of Thermo Fisher Scientific, offers experience, reliability – and a very broad range of sterile injectables clinical and commercial capabilities. We have an enviable record of steriles commercialization success for our clients. No CDMO has more sterile injectable new drug application (NDAs) than we do: from 2006-2017, we helped our clients earn 26 NDA approvals for sterile injectables.

Rapid growth continues in the biologics (large molecule) sector. The focus on patient and caregiver safety and convenience is mounting. All these elements are driving a strong increase in new therapies being delivered in sterile injectable dose forms. In addition to speed and flexibility in developing a broad range of sterile dose forms, we offer:

  • Flexible approaches to maximize speed and cost
  • Formulation and process development optimization for cost and quality
  • Proven technology transfer experience
  • Scalability to commercial manufacturing
  • A strong regulatory track record

Let us help you transform your discovery into a drug product with the best possible chance for approval. Contact us to discuss your steriles development project.

Download our full Dosage Form Brochure.