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.
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
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 |
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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.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability