cGMP Manufacturing

Custom cGMP manufacturing services you can trust

Powered by Avanti Research™ and Croda Pharma

Avanti Research™ and Croda Pharma together deliver end-to-end support for your drug development journey—from preclinical innovation to GMP-grade manufacturing. While Avanti Research focuses on high-purity, research-use-only (RUO) lipid-based products, Croda Alabaster is the FDA-inspected GMP manufacturing division of the company, offering pharmaceutical-grade solutions for excipients, APIs, and adjuvants.

How Can We Help?

cGMP manufacturing facility overview

Croda Pharma operates state-of-the-art, FDA-approved cGMP manufacturing facilities with over 80,000 sq/ft across five buildings on our Alabama campus. These facilities include:

  • Synthetic Organic Laboratories for early product development
  • Formulation development and manufacturing
  • GMP manufacturing for excipients and active pharmaceutical ingredients (APIs)
  • GMP adjuvant production for vaccines and immunotherapies
  • GMP analytical laboratories for method development, product testing, and stability studies

Our infrastructure supports small- to large-scale production while maintaining strict adherence to current Good Manufacturing Practices (cGMP).

What we offer

API and excipient manufacturing

Croda Pharma specializes in the manufacture of lipids and hydrophobic small molecule APIs, with capabilities spanning:

  • Preclinical R&D through Phase III clinical trials

  • Commercial-scale API production

  • Custom excipient development and scale-up

  • Full regulatory support (IND/NDA)

Every step is backed by the precision, purity, and regulatory alignment that defines Avanti’s legacy of excellence.

Development expertise that scales with you

Whether you're starting from a research concept or scaling a clinical product, our dedicated Development Team ensures a seamless transition through each development milestone. You’ll work with our seasoned synthetic organic chemists and lipid analysts who specialize in:

  • Synthetic process development

  • Non-GMP and cGMP scale-up

  • Analytical method development and validation

  • Full-scale cGMP manufacturing with process validation

  • IND/NDA support and commercial launch readiness

Products


    cGMP Analytical Testing Services

    As an FDA-licensed manufacturing and testing facility, Croda Alabaster delivers high-quality cGMP-compliant analytical services, including:

    • Method design, development, qualification, and validation

    • SOP development and full sample traceability

    • Lipid raw material and product release testing

    • ICH-based stability testing protocols

    • Quality assurance review and documentation

    We offer validated assays for NMR, HPLC-ELSD, LC-MS/MS, and GC, with robust protocols to ensure compliance, reproducibility, and regulatory readiness.

    Popular analytical services:

    Method validation
    We provide full method validation under 21 CFR 211.194(a)(2), including:

    • System suitability

    • Linearity, specificity, LOD, LOQ

    • Accuracy and precision

    • Robustness and reproducibility

    Stability testing of lipid-based products
    Custom ICH-compliant stability testing protocols ensure data-driven decision-making for shelf-life and performance of your lipid-based APIs or excipients.

    Why choose Croda Pharma for GMP manufacturing?

    By partnering with Croda, you benefit from:

    • 50+ years of lipid expertise from Avanti

    • Full cGMP compliance across excipient, API, and adjuvant production

    • Regulatory excellence and analytical rigor

    • A seamless bridge from research to GMP manufacturing

    • Flexible batch sizes and responsive project management

    • Peace of mind through traceable, transparent processes

    Whether you’re a researcher, startup, or pharmaceutical giant, we’re here to support your molecule from concept to commercialization.

    Let's start your GMP journey

    Ready to learn more about our cGMP services or request a quote?

    Email our GMP business development team directly at:
    avanti.gmprequest@croda.com