Certification
FDA-Registered CDMOs
Compare CDMOs with FDA registration for US-market pharmaceutical manufacturing. Filter by product type, inspection history, and manufacturing capabilities.
729 companies listed
About FDA Registration for CDMOs
FDA registration means a manufacturing facility has registered with the US Food and Drug Administration as required by the Federal Food, Drug, and Cosmetic Act. Every domestic and foreign establishment that manufactures, repacks, or relabels drugs for the US market must register annually. Registration is a legal requirement, not an endorsement of quality.
Registered does not mean approved. FDA registration is a notification, not a certification. The FDA does not "approve" manufacturing facilities -- it approves specific drug products. However, registered facilities are subject to FDA inspection, and inspection history is public record. Look up any facility's inspection results, Form 483 observations, and warning letters on the FDA's website.
What matters more than registration itself is inspection outcome. A facility with a clean inspection history (no Form 483 observations, or observations that were promptly remediated) demonstrates stronger quality systems than one with repeated citations. Voluntary Action Indicated (VAI) outcomes are common and acceptable. Official Action Indicated (OAI) outcomes suggest systemic quality problems.
Companies (729)
U
uBriGene
United States
uBriGene Biosciences Inc is the same entity as uBriGene (duplicate entry, different ID). This is the China-headquartered entity of the same global CRDMO providing one-stop viral vector-based CDMO services for research and clinical applications. Series C+ funding of 150M CNY (~$20M USD). Same website, same capabilities. See uBriGene entry (ID 10a6a05c) for full details.
Cell & Gene TherapyViral VectorsCell Therapy
Veeda Lifesciences
India
Veeda Lifesciences (formerly Veeda Clinical Research) is a tech-driven global CRO headquartered in Ahmedabad, India with presence in 9 countries and sites across 26 geographies. They rebranded in January 2025 and now operate through four Strategic Business Units: Clinical Trials, Healthy Volunteer Services, Biopharma Services, and a fourth unit. Services include pre-clinical research, bioanalytical testing, clinical development for generics/innovators/biotherapeutics, real-world evidence, regulatory affairs, medical writing, pharmacovigilance, and data science. They have 2,100+ employees and are transitioning to a CRO-CDMO model per recent announcements, though their current core business remains contract research. Specializations include hemato-oncology, monoclonal/bispecific/trispecific antibody development, and multiple myeloma trials.
Frequently Asked Questions
What does FDA-registered mean for a CDMO?+
FDA registration means the manufacturing facility has filed its annual registration with the FDA, identifying the establishment and listing the drugs manufactured there. This is a legal requirement for any facility making drugs for the US market. It does not mean the FDA has inspected or approved the facility. Think of it as the FDA knowing the facility exists and what it produces -- the inspection and approval processes are separate.
How do you check a CDMO's FDA inspection history?+
Search the FDA's Establishment Inspection Database at fda.gov. Enter the company name or FEI (FDA Establishment Identifier) number. The results show inspection dates, outcomes (NAI, VAI, or OAI), and any Form 483 observations issued. You can also check the FDA Warning Letters database for more serious enforcement actions. Ask the CDMO directly for their last 3 inspection reports and any CAPA (Corrective and Preventive Action) plans.
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