Compare CDMOs with FDA registration for US-market pharmaceutical manufacturing. Filter by product type, inspection history, and manufacturing capabilities.
3 companies listed
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.
Taiwan
Standard Chem. & Pharm. Co., Ltd. is a pharmaceutical CDMO offering comprehensive services.
India
Srikem Laboratories Pvt Ltd is a pharmaceutical CDMO offering comprehensive services.
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France
STERIGENE is a pharmaceutical CDMO offering comprehensive services.