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)
Shaoxing Renhe Capsule Co., Ltd.
China
Shaoxing Renhe Capsule Co., Ltd. is a world-leading manufacturer of empty hard capsules, specializing in both gelatin and Hypromellose (HPMC) vegetable capsules. The company supplies pharmaceutical excipient capsule shells to drug manufacturers globally and is FDA-registered, but does not manufacture finished pharmaceutical products or drug substances.
Shenzhen Boomingshing Medical Device Co., Ltd.
China
Shenzhen Boomingshing Medical Device Co., Ltd. (BMS Medical) is a Chinese manufacturer of plastic medical consumables and life science lab consumables. Products include microplates, deep well plates, PCR tubes/plates, pipette tips, and sequencing instrument accessories. The company provides end-to-end manufacturing for plastic consumables via precision injection molding and cleanroom production, serving IVD, life sciences, hemodialysis, and surgical robot markets. It does not manufacture drugs or pharmaceutical products.
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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