Suppliers / KVK-Tech

KVK-Tech

United States 221 employees Updated 9 July 2026

KVK-Tech is a finished-dose manufacturer based in United States. It appears in 41 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its most recent recorded inspection, by US FDA, closed on 14 March 2025 as OAI.

0
active US DMFs
0
valid CEPs
2
registered plants 2 with an FDA FEI number
41
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 14 March 2025 OAI US FDA
  • 21 October 2024 NAI US FDA
  • 8 July 2022 OAI US FDA
  • 16 April 2019 OAI US FDA
  • 21 September 2018 NAI US FDA
  • 27 June 2017 VAI US FDA
  • 11 December 2014 NAI US FDA
  • 9 December 2013 VAI US FDA

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

Registered plants

Site FDA FEI
NEWTOWN, United States 3005117563
Newtown, United States 3013676321

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 41 None

Questions about KVK-Tech

Does KVK-Tech hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for KVK-Tech. It does have 41 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is KVK-Tech FDA-registered?
2 sites operated by KVK-Tech carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did KVK-Tech's last inspection go?
The most recent inspection on record closed on 14 March 2025 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 8 inspections are on file, of which 3 closed as OAI.
Where does KVK-Tech manufacture?
2 registered sites are on record, in United States (Newtown and Newtown). Every site is listed on this page with the register it came from.
Where does KVK-Tech file?
Filings are on record with US FDA, 41 in total.

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

  • 51 active litigation matters are on record.
  • The most recent inspection outcome was OAI, on 14 March 2025.

Comparable suppliers

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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