Suppliers / Mylan Dublin

Mylan Dublin

Ireland Updated 9 July 2026

Mylan Dublin is an API and finished-dose manufacturer based in Ireland. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its filings concentrate with US FDA, JFDA (JO) and MCAZ (ZW). Its GMP standing is certified by CDSCO (India) and MHRA (UK).

2
active US DMFs
0
valid CEPs
12
registered plants
558
filings across 4 regulators

Registered plants

Site FDA FEI
Bangalore- 562105, United Arab Emirates Not on file
Bangalore 562105, United Arab Emirates Not on file
DUBLIN, Ireland Not on file
BANGALORE, India Not on file
hosur 635 130, India Not on file
Hosur –, India Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Fomepizole US FDA 1
Isosulfan Blue US FDA 1

Also appears on these molecule pages

Alprostadil finished dose Benazepril finished dose Cabazitaxel finished dose Cobicistat finished dose Fomepizole API Isosulfan Blue API Lopinavir finished dose Mesna finished dose Milrinone finished dose Nizatidine finished dose Norgestrel finished dose Oxybutynin finished dose
Show 1 more molecule pages
Ritonavir finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 546 None
JFDA (JO) 9 None
MCAZ (ZW) 2 None
EDE (AE) 1 None
CDSCO (India) None 10
MHRA (UK) None 2

Questions about Mylan Dublin

Does Mylan Dublin hold a US DMF or a CEP?
Mylan Dublin holds 2 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Where does Mylan Dublin manufacture?
12 registered sites are on record, in United Arab Emirates, Ireland and India (Bangalore- 562105, Bangalore 562105 and Dublin among others). Every site is listed on this page with the register it came from.
What does Mylan Dublin make?
2 molecules are on record against Mylan Dublin, including Fomepizole and Isosulfan Blue. Each links through to that molecule's full manufacturer list.
Which regulators recognise Mylan Dublin's GMP?
Current GMP certificates are on record from CDSCO (India) and MHRA (UK). 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

  • 79 active litigation matters are on record.
  • One recent serious compliance event is on record.

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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