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)
Polpharma API
Poland
Polpharma API is a European producer of Active Pharmaceutical Ingredients since 1951 and a CDMO provider, part of Polpharma Group. Headquartered in Poland with over 70 years of experience in process development, scale-up, and cGMP manufacturing. Advancing high potent API capabilities with OEL as low as 10 ng/m3 (OEB 5-6). Expanding into oligonucleotide production with GMP-compliant manufacturing up to 50g batch sizes. Offers cryogenic chemistry capabilities down to -90C. Operates kilo-lab, pilot, and commercial scale with Hastelloy and glass-lined reactors.
API ManufacturingSmall Molecule APIProcess Development
PolyCrystalLine S.r.l.
Italy
PCL Research & Manufacturing (PolyCrystalLine S.r.l.) is an Italian privately owned CRO/CDMO leader in contract research, development, and manufacturing, specializing in crystal form science for active pharmaceutical ingredients. Over 15 years of experience in solid state and crystallization chemistry. FDA-inspected analytical laboratories, GMP-certified by AIFA (Italian Medicines Agency). Authorized for HPAPI handling up to OEB5. Offers services from early-phase drug discovery to kilogram supply including polymorph screening, salt/co-crystal screening, crystallization process development, and kilo-lab scale manufacturing (up to 50L).
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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