Suppliers / Celltrion Pharm

Celltrion Pharm

South Korea 108 employees 4 duplicate records merged Updated 9 July 2026

Celltrion Pharm is a finished-dose manufacturer based in South Korea. It appears in 17 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with DAV (Vietnam), ARCSA (EC) and MINSA (CR). Its GMP standing is certified by US FDA, ANVISA (Brazil) and EMA. Its most recent recorded inspection, by US FDA, closed on 23 July 2024 as VAI.

0
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
17
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
1 of 1 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 23 July 2024 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
South, South Korea 3012279978
CHUNGCHEONGBUK-DO, South Korea Not on file
Cheongju, South Korea Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
DAV (Vietnam) 10 None
ARCSA (EC) 5 None
MINSA (CR) 2 None
US FDA None 1
ANVISA (Brazil) None 1
EMA None 1

Questions about Celltrion Pharm

Does Celltrion Pharm hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Celltrion Pharm. It does have 17 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Celltrion Pharm FDA-registered?
One site operated by Celltrion Pharm carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Celltrion Pharm's last inspection go?
The most recent inspection on record closed on 23 July 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Celltrion Pharm manufacture?
3 registered sites are on record, in South Korea (South, Chungcheongbuk-do and Cheongju). Every site is listed on this page with the register it came from.
Which regulators recognise Celltrion Pharm's GMP?
Current GMP certificates are on record from US FDA, ANVISA (Brazil) and EMA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was VAI, on 23 July 2024.

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates