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)
Biofer S.p.A.
Italy
Biofer S.p.A. is an independent Italian pharmaceutical company specializing in the manufacture of Active Pharmaceutical Ingredients (APIs) for nearly 40 years. Core products include iron complexes (antianemics), heparin and glycosaminoglycans, steroids, enzymes, and folinates. The company operates under strict GMP standards with an emphasis on quality, safety, and efficacy. FDA-registered with 3 inspections (0 NAI, 3 VAI).
Small Molecule APIFormulation DevelopmentAnalytical Services
Bioiberica S.A.U.
Spain
Bioiberica S.A.U. is a Spanish life science company and global leader in the manufacturing of heparin and glycosaminoglycan-based APIs. Core products include heparin sodium, heparin calcium, enoxaparin sodium, chondroitin sulfate, and hyaluronic acid. FDA-registered for API manufacture with 12 inspections (11 VAI, 1 OAI). The company supplies APIs to pharmaceutical companies globally but also has its own branded products. Operates major manufacturing facilities in Spain.
Small Molecule APIAPI ManufacturingAnalytical Services
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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