# Who may make drugs for the US market and who just stopped.

Canonical URL: https://www.rastriq.es/en/fda-drug-establishment-data/ · Spanish version: https://www.rastriq.es/datos-establecimientos-farmaceuticos-fda/

> All 10,500 firms registered with the US FDA to make, test or pack drugs, with FEI, DUNS and operations, plus the daily new, renewed, changed and removed firms.

The FDA drug establishment register (DECRS) as data: active ingredient makers, finished-dose plants, testing labs and packagers worldwide, with their FEI and DUNS identifiers. The FDA only publishes today's list; the actor keeps what the FDA does not: who registered, who renewed, what changed and who disappeared.

QUICK ANSWER

**Quick answer:** Every establishment registered with the US FDA to make, test, pack or label drugs worldwide, with FEI, DUNS, country, operations and expiry, plus the daily new, renewed, changed and removed firms the FDA does not keep. Sample of 100 rows in CSV and JSON.

10,451

Active establishments

2,506

Active ingredient (API) makers

Daily

New, renewed, changed and removed

See use cases → See real rows

CONTEXT

## What the FDA establishment register is

Every plant that makes, tests, packs or labels drugs for the US, wherever it is, must register with the FDA every year.

**Why it matters outside the US.** The register includes 1,184 establishments in China, 1,060 in India, 258 in Germany, 190 in France, 183 in Italy and 143 in Spain. It is the official list of who may supply the US pharma chain, with an FEI and a DUNS identifier to join with inspections, import alerts or the European EudraGMDP register.

| Operation | What it means | Establishments |
|---|---|---|
| MANUFACTURE | Drug manufacturing | 5,656 |
| ANALYSIS | Testing and control lab | 3,444 |
| API MANUFACTURE | Active ingredient manufacturing | 2,506 |
| LABEL · RELABEL | Labelling and relabelling | 2,259 · 657 |
| PACK · REPACK | Packing and repacking | 2,094 · 876 |
| STERILIZE | Sterilisation | 257 |
| POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION | PET drugs | 157 |

One establishment can declare several operations. Count on 12 October 2026.

**What the source does not keep.** The FDA replaces its file without keeping versions: a lapsed or withdrawn registration simply vanishes. The actor does: in *Delta* mode every run compares the complete file with the previous one and returns only what is new (`new`), what changed (`changed`, with `changed_fields` and the old values in `previous_values`) and what disappeared (`removed`).

**Filters never fool the history.** The actor always reads the whole source; filters only decide which rows you receive. So a removal is never missed or invented because of a filter, and runs where the source has not changed finish in seconds and only charge the start fee.

USE CASES

## What FDA establishment data is used for

Seven use cases: who uses them, what you do and which fields you need.

1 · Supplier qualification and CMO / CDMO due diligence

QA, procurement and sourcing teamsBefore approving a contract manufacturer or an API source, check by FEI or DUNS that it is registered, for which operations and until when; the missing US agent flag points to risks.**Result:** a dated qualification record, with the FDA file it came from.

Fields: `fei_number`, `duns_number`, `operations`, `expiration_date`, `source_updated_at`

2 · Alert when a supplier drops off the register

Supply-chain risk and vendor managementSchedule Delta daily for the countries you source from and filter `change_type = removed`. The first real comparison already showed 8 removals from one day to the next.**Result:** an early warning before a shipment or an audit finds out.

Fields: `change_type`, `last_seen_at`, `firm_name`, `country_iso3`

3 · New API sites in India and China

Market intelligence and sourcingDaily Delta with countries `IND` and `CHN` and operation `API MANUFACTURE`: `new` rows are new Asian API makers entering the US chain (today 564 in India and 533 in China).**Result:** a live list of new entrants.

Fields: `firm_name`, `country_iso3`, `operations`, `registrant_name`, `agent_name`

4 · Regulatory competitor radar

Regulatory affairs, strategy and analysts `changed` rows say what changed and how it was before: a competitor adding sterilisation, moving site or switching US agent, without rereading the whole list every month.**Result:** capacity and structure changes at competitors, on the day they happen.

Fields: `changed_fields`, `previous_values`, `operations`, `agent_name`

5 · Prospecting for US agent and registration services

Regulatory consultancies and US-agent providersForeign establishments need a US agent and a yearly renewal. Pick new and renewed firms outside the US and look for those with no agent, or use the expiry date to time your outreach.**Result:** a list of companies (never people) refreshed daily.

Fields: `change_type`, `agent_duns`, `quality_flags`, `expiration_date`

6 · Enrich a supplier master by FEI or DUNS

Master-data teamsJoin your vendor table to the register on DUNS (always 9 digits) or FEI + DUNS, the unique key. Flags tell you which IDs were repaired or are shared.**Result:** registration status, operations and agent on every vendor, and a key to join with EudraGMDP.

Fields: `duns_number`, `fei_number`, `quality_flags`

7 · Track the renewal campaign (October–December)

Compliance and account managersAlmost every registration expires on 31 December. `renewed` rows show who has renewed (with the old date); in a full snapshot, firms still on the old date have not. On the first compared day alone there were 381 renewals.**Result:** who has and has not renewed, in time to act.

Fields: `change_type`, `expiration_date`, `previous_values`

REAL SAMPLE

## One day of changes and two saved tasks

What the FDA does not publish (the changes) and two ready-to-use extracts. Samples download without signing up.

### New, changed and removed firms in a single day

| change_type | firm_name | country_iso3 | operations | changed_fields |
|---|---|---|---|---|
| new | BioSpectra Inc. | USA | API MANUFACTURE | — |
| new | Pherros Biosciences | USA | ANALYSIS \| LABEL \| MANUFACTURE \| PACK | — |
| changed | American Welding & Gas, Inc. | USA | MANUFACTURE | firm_name \| expiration_date |
| changed | Radix Acquisition Company, LLC | USA | ANALYSIS \| LABEL \| MANUFACTURE \| REPACK | address_raw \| operations \| expiration_date |
| removed | Westway Feed Products LLC | USA | MEDICATED ANIMAL FEED MANUFACTURE | — |
| removed | FORTUNE PHARMACAL COMPANY, LIMITED | HKG | MANUFACTURE | — |

Real rows from a Delta run on 12 October 2026 over the whole register: 381 renewals, 23 changes, 9 new firms and 8 removals from one day to the next.

### API makers in India and China

| fei_number | firm_name | country_iso3 | operations | expiration_date |
|---|---|---|---|---|
| 1000172912 | Biocon Limited | IND | ANALYSIS \| API MANUFACTURE | 2026-12-31 |
| 1000202341 | Oriental Aromatics Limited | IND | API MANUFACTURE | 2027-12-31 |
| 1000212072 | Capri Aromatics Pvt Ltd | IND | API MANUFACTURE | 2026-12-31 |
| 1000283831 | Embio Limited | IND | ANALYSIS \| API MANUFACTURE | 2026-12-31 |
| 1000308605 | Inner Mongolia Huashu Biological Technology… | CHN | API MANUFACTURE | 2026-12-31 |
| 1000390117 | Chifeng Pharmaceutical Co. Ltd | CHN | API MANUFACTURE | 2026-12-31 |

Real rows from the "new API makers in India and China" task (first run, baseline).

### European manufacturers registered with the FDA

| fei_number | firm_name | country_iso3 | operations | expiration_date |
|---|---|---|---|---|
| 0000001196 | Italfarmaco SPA | ITA | ANALYSIS \| LABEL \| MANUFACTURE \| PACK | 2026-12-31 |
| 1000171152 | Astrea Monts | FRA | ANALYSIS \| LABEL \| MANUFACTURE \| PACK | 2026-12-31 |
| 1000173162 | FAREVA Mirabel | FRA | ANALYSIS \| LABEL \| MANUFACTURE \| PACK | 2027-12-31 |
| 1000181428 | INTERCOS EUROPE SPA | ITA | MANUFACTURE | 2026-12-31 |
| 1000261402 | Boiron | FRA | LABEL \| MANUFACTURE | 2026-12-31 |
| 1000268008 | CIS Bio International | FRA | ANALYSIS \| API MANUFACTURE \| MANUFACTURE \| PACK \| STERILIZE | 2027-12-31 |

Real rows from the "FDA-registered drug manufacturers in Europe" task (Germany, France, Italy and Spain).

**No personal data.** The FDA file carries contact names and emails: the actor never collects them, and when the registrant or agent is an individual the name is removed and flagged.

[FDA establishments CSV](https://www.rastriq.es/muestras/fda-establecimientos.csv) [FDA establishments JSON](https://www.rastriq.es/muestras/fda-establecimientos.json) [Browse all samples](https://www.rastriq.es/en/samples/)

RECIPES

## Inputs ready to copy

Paste the input into the actor's JSON tab and press Start. Countries use three-letter ISO codes.

| Task | Input (JSON) | What it is for |
|---|---|---|
| European manufacturers | `{"mode": "snapshot", "countries": ["DEU","FRA","ITA","ESP"], "operations": ["MANUFACTURE"]}` | Saved sample task: supplier shortlist. |
| New APIs in India and China | `{"mode": "delta", "countries": ["IND","CHN"], "operations": ["API MANUFACTURE"]}` | Saved sample task, scheduled daily. |
| Removal alert for my countries | `{"mode": "delta", "countries": ["ESP","ITA","IND"], "includeRenewals": false}` | Only real changes, without renewal noise. |
| Spanish, Italian and German CMOs | `{"mode": "snapshot", "countries": ["ESP","ITA","DEU"], "operations": ["MANUFACTURE","ANALYSIS"]}` | Manufacturers and labs to join with your vendor master. |
| Worldwide register with daily changes | `{"mode": "delta", "maxItems": 0}` | Full base on day one, then only changes. |
| Instant full dump | `{"mode": "preloaded"}` | Copy prepared by Rastriq at the lowest price per row. |

On days when the FDA file has not changed, the Delta run finishes in seconds with no per-row charge.

| Mode | What it returns | When to use it |
|---|---|---|
| snapshot | The full current picture with your filters | A one-off extract or a first load |
| delta | 1st run: everything as baseline. Then only new / changed / removed | Scheduled: alerts, monitoring, history |
| preloaded | Full copy prepared by Rastriq, instantly and cheaper per row | Bulk dump with no waiting and no history |

FIELDS

## Field dictionary

One row per establishment, keyed by FEI + DUNS.

| Field | Description |
|---|---|
| `fei_number · fei_raw` | FDA establishment identifier (normalised to 10 digits) and original |
| `duns_number` | Establishment D-U-N-S (9 digits). FEI + DUNS is the unique key |
| `firm_name · address_raw · country_iso3` | Firm, address and country |
| `operations · operations_raw` | Registered operations: MANUFACTURE, API MANUFACTURE, ANALYSIS, PACK, LABEL, STERILIZE… |
| `expiration_date` | Registration end date (almost always 31 December) |
| `registrant_name · registrant_duns` | Company that registers the establishment |
| `agent_name · agent_duns` | US agent (companies only; no contact details) |
| `is_excluded` | Establishment excluded by the FDA (optional) |
| `source_updated_at · first_seen_at · last_seen_at` | FDA file date, first and last seen |
| `change_type · changed_fields · previous_values` | baseline / new / renewed / changed / removed |
| `quality_flags` | fei_zero_padded, shared_fei, fei_missing, agent_missing_foreign, expiration_past, agent_name_person_removed… |

DELIVERY

## How you receive the data

Run it yourself, receive it on a schedule or commission the project.

Apify

You run the actor with your filters and download Excel, CSV or JSON. About $1 per 1,000 establishments, $5 per 1,000 changes and $0.50 per 1,000 in preloaded (Bronze plan). The full worldwide register costs about $10.

Channels: console, API, MCP

Recurring dataset

Full register or your countries with the daily history of new, renewed, changed and removed firms.

Channels: S3, CSV, JSON

Custom project

Matching with your supplier master and with the European EudraGMDP register for an EU + US view of every plant.

[EudraGMDP data →](https://www.rastriq.es/en/eu-pharma-licence-data/)

FAQ

## Frequently asked questions about FDA establishment data

### Where does the data come from?

From the public drug establishment registration file (DECRS) the FDA publishes on accessdata.fda.gov. Every row carries its source file and date.

### What does it add over downloading the FDA file?

The file is only today's picture. The actor keeps state and tells you every day who registered, who renewed, what changed (with the old value) and who disappeared. It also normalises FEI, DUNS and operations and removes personal data.

### Can I ignore renewals?

Yes. October to December brings many renewals; switch off "include renewals" and they are neither returned nor billed, and they do not come back later.

### Why does one FEI appear on several rows?

Because an establishment can be registered under two DUNS numbers or two address variants (about 6 % of rows). Use FEI + DUNS as the key; those rows carry the `shared_fei` flag.

### Is personal data included?

No. Contact names, emails and phone numbers are always discarded, and registrants or agents who are individuals are blanked and flagged.

### Can it be joined with EudraGMDP?

Yes, as a custom project: we match each FDA-registered plant with its European licences and GMP certificates for an EU + US view of each supplier.

FREE SAMPLE

## Get an extract for your countries and operations

Tell us countries, operations or firms and we will send an extract in the schema you would receive.

- Over 100 countries
- New, renewed, changed and removed
- No personal data

Received. Meanwhile, download the real samples at [/en/samples/](https://www.rastriq.es/en/samples/).

RELATED PAGES

## Keep exploring

[EudraGMDP data Licences and GMP in Europe.](https://www.rastriq.es/en/eu-pharma-licence-data/) [Public data Every official data source.](https://www.rastriq.es/en/public-data/) [Buy datasets Catalogue with downloadable samples.](https://www.rastriq.es/en/buy-datasets/) [Rastriq for AI How agents read this data.](https://www.rastriq.es/en/ai/)