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)
B
Berko Pharmaceuticals
Turkey
Berko Pharmaceuticals is a Turkish pharmaceutical company involved in the development, manufacturing, and marketing of pharmaceutical products including solid dosage forms and suppositories. Listed on CPHI as a CDMO specializing in development and manufacturing, with FDA-registered facilities and a long track record of FDA-inspected production (2 NAI inspections). Also has 27 FDA recalls on record, indicating substantial US market supply history.
Small Molecule Drug ProductOral Solid DoseFormulation Development
BioIVT
United States
BioIVT is a global provider of biological research products and services, specializing in biospecimen solutions, ADME-Tox in vitro models, control matrices, and diagnostic solutions for drug and diagnostic development. They have opened a GMP-compliant facility for cell and gene therapy R&D materials but are primarily a biospecimen/research services company, not a drug manufacturer.
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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