Commercial Production
With deep commercial manufacturing experience—across the US, Canada, EU, Japan and beyond—we offer the knowledge of international regulatory requirements to seamlessly bring your product into markets across the globe. We emphasize operational stability and reliability so you can count on us to support your needs through on-time product release, no matter where you are today.
Our process
Commercial Manufacturing for International Markets
We currently manufacture multiple drug products for distribution to markets across the globe. Our quality and regulatory staff have extensive experience supporting clients through the Pre-Approval Inspection and approval process, including designing and executing validation batch (PPQs and PV) studies to support your NDA submission.
01
Vial & Prefilled Syringe Filling
Since our inaugural commercial manufacturing run in 2015, we have specialized in vial and prefilled syringe filling for several commercial products intended for global markets.
02
Packaging, Storage & Distribution
Our controlled access and video-monitored labeling and packaging suites are adjacent to controlled-temperature storage, for seamless transfer between areas before international shipment.
03
Regulatory Support
We offer extensive experience with regulatory filing, FDA inspections, QP inspections, mock inspections, commercial audits and international regulatory approval processes.
Our services
Dependable, from Commercial Manufacturing to Compliance
Our services are designed to deliver on your specific needs, bringing the right mix of scientific acumen and regulatory expertise to move your product through manufacturing and approval.
Lyophilization
Development and GMP manufacturing for lyophilized drug products
Labeling, Storage & Distribution
ICH-compliant GMP storage. Global distribution
Commercial Manufacturing
GMP Drug Product Manufacturing for International Markets
Our capabilities
Our Commercial Know-How. Your Peace of Mind.
Whether your product is on the path to approval or has been on the market for years, Pyramid Pharma Services can enhance the value and security of your commercial supply chain. We’ve assisted numerous clients in achieving successful commercial approval across the US and international markets.
- IMA vials fill line equipped with 100% weight check for liquid and lyophilized drug products
- Filling of prefilled syringes
- New Groninger high-speed line for syringes, vials and cartridges
- Commercial packaging & labeling
- Commercial production of approved products for markets in the US, Canada, EU, Japan, Australia and more
Our facilities
Liquid or Lyo, Vial or Syringe
For over 24 years, Pyramid Pharma Services has been a reliable partner for commercial manufacturing. Whether it’s liquid or lyophilized, vial or syringe, we can scale our capabilities to align with the needs of your commercial program. Our three facilities at the Costa Mesa, CA site host state-of-the-art equipment, including fully Annex 1 compliant, highly automated filling lines.
How Can We Help?
Let us apply our 37+ years of experience to help you solve your development and supply challenges. Learn more about what it means to differentiate your development process with Pyramid Pharma Services.