FDA-Registered Drug Establishments Outside the U.S.
81 countries outside the U.S. · 4,815 locations
There are 4,815 FDA-Registered Drug Establishments Outside the U.S. in 81 countries as of October 2026.
4,815 drug sites outside the U.S. with a current FDA registration, read on 26 October 2026 from FDA's Drug Registration and Listing System file.
More about this list
These are the plants and labs that make, test or pack drugs and active ingredients shipped to the U.S. China has 1,192, India 1,063, Germany 259, Canada 229, France 191 and Italy 181, out of 81 countries. 1,979 are registered to make active ingredients (API) and 2,393 to make finished drugs. Each row has the address, FDA's operations, the FEI and DUNS numbers, the registrant, the contact name and email, and the site's U.S. agent. Pharmaceuticals are under a Section 232 national security investigation (opened 1 April 2025).
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●Where the rows are
≡Sample Data Preview
| name | address | city | state | zip | registrant | operations | operation count | manufactures drugs | manufactures api | sterilizes | country code | contact name | registrant contact name | registrant email | us agent | fei number | duns number | registrant duns number | registration expires | section232 sector | address as published | name as published | source file | source date | row id | directions url | naics code | naics title | sic code | sic title | updated date | address quality | country | source url | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Minakem High Potent | Rue Fonds Jean Paques 8, 1435, Mont-Saint-Guibert | (Corbais) | 1435 | Minakem High Potent | Analysis; Api Manufacture | 2 | N | Y | N | BEL | Marie-Jose De Andrade | regulatory.affairs@minakem.com | Stephanie Boffa | stephanie@interchem.com | 785628368 - Interchem Corporation - stephanie@interchem.com - 1-201-261-7333 | 3002807801 | 370937537 | 370937537 | 12/31/2026 | pharmaceuticals | Rue Fonds Jean Paques 8, 1435,, Mont-Saint-Guibert, (Corbais), 1435, Belgium (BEL) | Minakem High Potent | https://www.accessdata.fda.gov/cder/drls_reg.zip | 2026-10-26 | 370937537 | https://www.google.com/maps/dir/?api=1&destination=Rue%20Fonds%20Jean%20Paques%208%2C%201435%2C%20Mont-Saint-Guibert%2C%20(Corbais)%2C%201435%2C%20Belgium | 325412 | Pharmaceutical Preparation Manufacturing | 2834 | Pharmaceutical Preparations | 2026-10-26 | no_house_number | Belgium | https://www.accessdata.fda.gov/scripts/cder/drls/default.cfm | |
| Zoetis Belgium S.a. | Sragh Technology Park | Tullamore | Co. Offaly | Zoetis Inc | Manufacture; Analysis; Api Manufacture | 3 | Y | Y | N | IRL | Conor O'Dea | conor.odea@zoetis.com | Tonya Murphy | tonya.murphy@zoetis.com | 078579659 - Richard Osborne - richard.osborne@zoetis.com - 1-973-443-2944 | 3015596301 | 986062582 | 828851555 | 12/31/2026 | pharmaceuticals | Sragh Technology Park, Tullamore, Co. Offaly , Ireland (IRL) | Zoetis Belgium S.a. | https://www.accessdata.fda.gov/cder/drls_reg.zip | 2026-10-26 | 986062582 | https://www.google.com/maps/dir/?api=1&destination=Sragh%20Technology%20Park%2C%20Tullamore%2C%20Co.%20Offaly%2C%20Ireland | 325412 | Pharmaceutical Preparation Manufacturing | 2834 | Pharmaceutical Preparations | 2026-10-26 | no_house_number | Ireland | https://www.accessdata.fda.gov/scripts/cder/drls/default.cfm | |
| TaiMed Biologics Inc. HsinChu Branch | No. 18, Lane 15, Shengyi 5th Rd. | Zhubei | Hsinchu County | 302041 | TaiMed Biologics Inc. HsinChu Branch | Analysis | 1 | N | N | N | TWN | Julie Chen | zchen@taimedbio.com | Jimmy Chang | cchang@taimedbio.com | 018943424 - Taimed Biologics USA Corp. - jho@taimedbio.com - 1-917-803-7770 | 3016969638 | 657479860 | 657479860 | 12/31/2027 | pharmaceuticals | No. 18, Lane 15, Shengyi 5th Rd., Zhubei, Hsinchu County 302041, Taiwan (TWN) | TaiMed Biologics Inc. HsinChu Branch | https://www.accessdata.fda.gov/cder/drls_reg.zip | 2026-10-26 | 657479860 | https://www.google.com/maps/dir/?api=1&destination=No.%2018%2C%20Lane%2015%2C%20Shengyi%205th%20Rd.%2C%20Zhubei%2C%20Hsinchu%20County%2C%20302041%2C%20Taiwan | 325412 | Pharmaceutical Preparation Manufacturing | 2834 | Pharmaceutical Preparations | 2026-10-26 | no_house_number | Taiwan | https://www.accessdata.fda.gov/scripts/cder/drls/default.cfm |
| Livzon Group (Ningxia) Pharmaceutical Co.,Ltd. | Toushi Road West, 301 Provincial Highway South, Pingluo Industrial Park | Shizuishan | Ningxia | 753400 | Livzon Group (Ningxia) Pharmaceutical Co., Ltd. | Analysis; Api Manufacture | 2 | N | Y | N | CHN | Tong Wu | nxnnrzc@126.com | Tong Wu | nxnnrzc@126.com | 791459840 - Pharmaports LLC - ppl@pharmaports.com - 1-610-524-7888 | 3012375554 | 543265333 | 543265333 | 12/31/2026 | pharmaceuticals | Toushi Road West,301 Provincial Highway South, Pingluo Industrial Park, Shizuishan, Ningxia 753400, China (CHN) | Livzon Group (Ningxia) Pharmaceutical Co.,Ltd. | https://www.accessdata.fda.gov/cder/drls_reg.zip | 2026-10-26 | 543265333 | https://www.google.com/maps/dir/?api=1&destination=Toushi%20Road%20West%2C%20301%20Provincial%20Highway%20South%2C%20Pingluo%20Industrial%20Park%2C%20Shizuishan%2C%20Ningxia%2C%20753400%2C%20China | 325412 | Pharmaceutical Preparation Manufacturing | 2834 | Pharmaceutical Preparations | 2026-10-26 | complete | China | https://www.accessdata.fda.gov/scripts/cder/drls/default.cfm |
| KAKEN Pharmaceutical Co., LTD | 301 Gensuke | Fujieda-shi | Shizuoka | 426-8646 | KAKEN Pharmaceutical Co., LTD | Manufacture; Analysis; Api Manufacture; Label; Pack | 5 | Y | Y | N | JPN | Hidenori Funamizu | funamizu_hidenori@kaken.co.jp | Akihiko Okuyama | okuyama_akihiko@kaken.co.jp | 828710405 - Premier Research International LLC - Laura.Kilgore@premier-research.com - 1-919-627-9100 | 3002807376 | 706296951 | 690543079 | 12/31/2026 | pharmaceuticals | 301 Gensuke, Fujieda-shi, Shizuoka 426-8646, Japan (JPN) | KAKEN Pharmaceutical Co., LTD | https://www.accessdata.fda.gov/cder/drls_reg.zip | 2026-10-26 | 706296951 | https://www.google.com/maps/dir/?api=1&destination=301%20Gensuke%2C%20Fujieda-shi%2C%20Shizuoka%2C%20426-8646%2C%20Japan | 325412 | Pharmaceutical Preparation Manufacturing | 2834 | Pharmaceutical Preparations | 2026-10-26 | complete | Japan | https://www.accessdata.fda.gov/scripts/cder/drls/default.cfm |
{}What's in each row
| Field | What it is | Rows filled |
|---|---|---|
| name | Establishment name as registered with FDA (all-capitals names set in title case) | 100% |
| registrant | Firm that filed the registration | 100% |
| operations | FDA's list of what the site does: Manufacture, API Manufacture, Analysis, Label, Pack, Repack, Relabel, Sterilize and others | 100% |
| operation | How many FDA operations the site is registered for | 100% |
| manufactures | Y when the operations include Manufacture | 100% |
| manufactures | Y when the operations include API Manufacture (active ingredients) | 100% |
| sterilizes | Y when the operations include Sterilize | 100% |
| address | Street address of the site | 100% |
| city | City | 100% |
| state | Two-letter state code (U.S. lists); region as FDA writes it, Canadian provinces as two-letter codes (foreign lists) | 72% |
| zip | ZIP or postal code | 95% |
| country | Country (U.S. lists: US) | 100% |
| country | FDA's three-letter country code | 100% |
| contact | Contact person FDA publishes for the site (drugs: establishment contact; devices: official correspondent) | 100% |
| Establishment contact email FDA publishes | 100% | |
| registrant | Registrant's contact person | 100% |
| registrant | Registrant's contact email | 100% |
| us | U.S. agent FDA lists for the site: DUNS, name and email | 100% |
| fei | FDA Establishment Identifier (FEI) | 98% |
| duns | DUNS number of the registered site (one row per DUNS) | 100% |
| registrant | DUNS number of the registrant | 100% |
| registration | Date the current registration expires | 100% |
| section232 | Section 232 investigation the site falls under (pharmaceuticals; medical devices and PPE) | 100% |
| address | The address line exactly as FDA writes it | 100% |
| name | Establishment name exactly as FDA writes it | 100% |
| source | FDA's public search page for the register (devices: the registration's own page) | 100% |
| source | FDA bulk file the row was read from | 100% |
| source | Date of the FDA file | 100% |
| row | Row id: the site's DUNS number (drugs) or FDA's registration record key (devices) | 100% |
| directions | Google Maps directions link to the site | 100% |
| naics | NAICS code (drugs 325412, devices 339112) | 100% |
| naics | NAICS title | 100% |
| sic | SIC code (drugs 2834, devices 3841) | 100% |
| sic | SIC title | 100% |
| updated | Date the list was built | 100% |
| address_ | complete, no house number, po box, missing city or zip or missing | 100% |
Rows filled is measured on every row of the delivered file.
✓Where this data comes from
Each row names the public source it came from, so any record can be checked against where it was published.
October 26, 2026
Snapshot built
36 fields
Columns in the file
Fill measured
On every row of the delivered file
How we build and date every file: methodology.
Using ChatGPT, Claude or an API?
No setup needed. Ask ChatGPT or Claude your question about the FDA-Registered Drug Establishments Outside the U.S. and give it this page: it can open https://locationlists.com/find?dataset=foreign-fda-registered-drug-manufacturer-list with the filters you need and show you the count and price.
Using ChatGPT or Claude? Tell it to answer from locationlists.com/find — no account, no connector.
How assistants ask
No connector needed. Any AI assistant can answer from this site with a web link, no connector, no account: open https://locationlists.com/find with the question as query parameters.
If a question needs filtering, distance, combining lists or a price, open a /find link: either put the question itself in q=, or build the structured link. The answer does not need an API, a connector or an account.
Simplest, the question itself: https://locationlists.com/find?q=<the question in plain words>
Or set the parts yourself: https://locationlists.com/find?dataset=<slug>&state=<ST>&city=<city>&county=<county>&zip=<zip>&near=<place or zip>&radius=<miles>&where=<column>:<op>:<value>&total=<rows>
Leave out what the question does not need. Distance is radius, in straight-line miles; near can name several places separated by | to reach from any of them. To ask about several lists at once, use datasets with two or more names, or category with a kind of business. To compare two lists, add relate=nearest and the other list with b. in front of its parameters. To count by area, use areas=county (or zip, state, metro). To keep only places whose county, ZIP code, metro area or state meets a Census figure, add area_where (for example county:population>1000000); with areas, per=100000 gives counts per 100,000 residents.
Links an assistant can open, each showing how many rows match, a few preview rows and the price for just that part:
- Only rows where manufacturesDrugs is Y: https://locationlists.com/find?dataset=foreign-fda-registered-drug-manufacturer-list&where=manufacturesDrugs%3Aeq%3AY
- The whole list: add a city, state, ZIP code or distance:
https://locationlists.com/find?dataset=foreign-fda-registered-drug-manufacturer-list
Optional: connect for repeat use or wallet payments:
Read https://locationlists.com/skill.md and follow the instructions to connect LocationLists. Then show me the FDA-Registered Drug Establishments Outside the U.S. list.Your assistant will walk you through setup and show you the price before you pay.
For developers
At 4,815 records this dataset is not sold by the row — buy the file. Without a connector, open https://locationlists.com/find?dataset=foreign-fda-registered-drug-manufacturer-list. An agent connected to https://locationlists.com/mcp can still search it, read a free sample file of up to 10 rows and buy the whole file itself. How agent purchasing works
?Frequently Asked Questions
How many FDA-Registered Drug Establishments Outside the U.S. are there worldwide?
There are 4,815 FDA-Registered Drug Establishments Outside the U.S. in 81 countries as of October 2026.
Which sites are in it?
Every site outside the U.S. with a current registration in FDA's drug registration file on 26 October 2026. One row is one DUNS number, the unit FDA registers.
What is the U.S. agent?
FDA requires every foreign drug site to name an agent in the U.S. The usAgent column has the agent's DUNS, name and email as FDA publishes them.
How are the addresses split?
FDA writes a foreign address on one line. We split it into street, city, region and postal code. The original line is kept in addressAsPublished. Foreign rows have no map point.
How current is the data?
Snapshot built on October 26, 2026. It is a one-time snapshot and is not rebuilt on a schedule.