Methodology and sources
Sources
Every establishment registered to manufacture, test, package or label drugs for the US market, worldwide.
Refreshed each business day by the FDA; ingested weekly.
Marketed drug products and the labeller responsible for each.
Updated daily by the FDA; ingested weekly.
Approved products, patents and regulatory exclusivity. Drives the patent cliff pages.
Monthly.
Products currently reported in shortage, with availability and therapeutic category. The feed carries no reason-for-shortage field.
Ingested daily.
The joined result of all four sources is available as a CSV dataset, with a free sample: the register as data.
How companies are resolved
The hard part is not obtaining the data, it is joining it. The same company appears as “TEVA PHARMACEUTICALS USA, INC.” in one file, “Teva Pharmaceuticals USA, Inc.” in another and “TEVA PHARMS USA” in a third. We reduce every name to a normalised key by stripping legal forms, regional qualifiers and industry filler, then group on that key.
Two deliberate exceptions. Some names collide across genuinely unrelated companies: Merck & Co. of Rahway, New Jersey and Merck KGaA of Darmstadt share a name for historical reasons and are separate businesses, so those are kept apart by their legal form. And generic business words are stripped only from the end of a name, so that “Linde Gas & Equipment” and “Linde Inc.” resolve together without “Air Products and Chemicals” losing its identity.
Roughly one FDA drug establishment registrant in five is a medical gas supplier, a medicated animal feed mill or a home medical equipment provider. Oxygen is a regulated drug, so a welding gas distributor can hold hundreds of registrations. These are validly registered and we keep them, but they are classified into separate segments so they do not dominate rankings of pharmaceutical companies.
Reading a company entry
- Registration is not approval. An establishment on the FDA register is one the FDA knows about and may inspect. It is not an FDA approval, endorsement or certification of the company or of anything it makes. Drug approvals are granted to applications, not to companies.
- Registered operations are what each site is registered to perform (manufacture, API manufacture, analysis, packing, labelling and so on). They are the regulatory record, not a list of the services a company markets.
- No registered site is normal for an application holder that outsources manufacturing: its products are made at establishments registered to other firms.
- NDC counts are the number of distinct products labelled for the US market. They are not a measure of sales or manufacturing volume, and a repackager can outnumber a large manufacturer. A labeller is the firm named on the label, which is not always the manufacturer.
- Shortages are listings in the FDA drug shortage database that name the company. The feed carries no reason-for-shortage field, so no cause is stated.
- Patents and exclusivities are unexpired Orange Book entries where the company is the application holder. Exclusivity codes are the FDA's own (for example NCE, new chemical entity; ODE, orphan drug exclusivity; PED, paediatric exclusivity).
- Data as ofis the latest date on which any of the entry's own federal records changed.
- Thin entries. An entry whose whole record is one establishment or one product listing, with no patent, shortage or claim, stays on the site but is not offered to search engines.
Limitations
- Registration is not endorsement. A registered site is authorised to perform an operation. It says nothing about quality, capacity or whether the site would pass your audit.
- Corporate groups are messy. Subsidiaries, joint ventures and recently acquired entities may appear separately until the federal record catches up with the deal.
- Patent expiry is not loss of exclusivity. Paediatric extensions, regulatory exclusivity, 30-month stays and settlements routinely move the effective date.
- This covers the US market. A manufacturer that supplies only non-US markets has no reason to register with the FDA and will not appear.
On contact details
The FDA publishes a named contact and email address for every registered establishment. We ingest that field but deliberately never display it. Republishing several thousand individual work email addresses would make this site a scraping target and would be a poor way to treat the people named in a regulatory filing. Contact routes on a profile are ones the company chose to publish by claiming it.
Corrections
If something here is wrong, tell us and we will fix it. Email [email protected], or claim your profile to edit it directly. We do not accept payment to remove or alter facts drawn from the federal record.