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  • What We Do
    Our Services

    We offer the pharmaceutical and biotech industries a wide range of services for both Clinical and Commercial products.

    Drug Product Development

    Formulation and process development for liquid & lyophilized products

    Lyophilization

    Development and GMP manufacturing for lyophilized drug products

    Clinical Manufacturing

    GMP manufacturing and distribution for clinical trials

    Commercial Manufacturing

    FDA-registered facility currently making products for global distribution

    Biologics & Novel Modalities

    Drug product development and manufacturing for biologics and other novel modalities

    Analytical Services & QC Testing

    Method development, validation and testing

    Stability Studies

    Long-term, accelerated and in-use GMP stability studies

    Quality Assurance & Regulatory Support

    GMP manufacturing, testing and associated processes

    Labeling, Storage & Distribution

    ICH-compliant temperature controlled GMP storage and global distribution

  • How We Help
    Overview

    Pyramid Pharma Services has helped many clients on their journey from early stage all the way to commercial approval.

    Formulation & Development
    Formulation & Development

    Pyramid Pharma Services has a proven track record of helping clients successfully move from clinical stage to commercial approval.

    Clinical Supply
    Clinical Supply

    Pyramid Pharma Services has a proven track record of helping clients successfully move from clinical stage to commercial approval.

    Commercial Production
    Commercial Production

    Pyramid Pharma Services manufacture multiple commercial drug products for distribution to international markets.

  • About Us
    Who We Are

    We deliver the highest quality from early-stage development through commercial production.

    Our Expert Team

    Our accomplished team brings expertise in formulation, testing, and manufacturing — ensuring top-quality services.

    Work At Pyramid

    Join us in shaping the future of drug development and manufacturing, one breakthrough at a time.

  • News & Events
    News
    Upcoming Events
Contact us

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
Contact Our Experts

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 drug development and supply challenges. Learn more about what it means to differentiate your development process with Pyramid Pharma Services.

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A trusted drug development and manufacturing partner, 37 years and counting.
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