Suppliers / Zentiva, k.s

Zentiva, k.s

United Kingdom Updated 9 July 2026

Zentiva, k.s is a finished-dose manufacturer based in United Kingdom. It appears in 6,928 regulatory filings across 17 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), EMA and MHRA (UK). Its GMP standing is certified by MHRA (UK), EAEU_EEC and EMA, among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 13 February 2025 as NAI.

0
active US DMFs
0
valid CEPs
6
registered plants 1 with an FDA FEI number
6,928
filings across 17 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 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

  • 13 February 2025 NAI US FDA
  • 7 February 2019 NAI US FDA
  • 1 July 2016 VAI US FDA
  • 19 May 2012 NAI US FDA
  • 4 September 2009 VAI US FDA

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

Registered plants

Site FDA FEI
SUTTON-IN-ASHFIELD, United Kingdom Not on file
SUTTON-IN-ASHFIELD, United Kingdom Not on file
GUILDFORD, United Kingdom Not on file
Ankleshwar, India 3004086396
Ankleshwar, India Not on file
ankleshwar 393 002bharuch, India Not on file

What they file, and where

Molecule Regulators Docs
Tetryzoline SFDA (Saudi Arabia) 1

Also appears on these molecule pages

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Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 3,490 None
EMA 1,060 2
MHRA (UK) 743 6
ANSM (FR) 580 None
MPA (SE) 313 None
FAMHP (BE) 210 None
EAEU_EEC None 2
CDSCO (India) None 2
US FDA None 1
MINPROMTORG (RU) None 1

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Open risk flags

  • The most recent inspection outcome was NAI, on 13 February 2025.

Sources on this page

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