Suppliers / Hvl Pharma Uk

Hvl Pharma Uk

United Kingdom Updated 9 July 2026

Hvl Pharma Uk is an API manufacturer based in United Kingdom. It holds one active US drug master file. Its GMP standing is certified by MHRA (UK). Its most recent recorded inspection, by US FDA, closed on 3 November 2022 as VAI.

1
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 3 November 2022 VAI US FDA
  • 22 July 2019 VAI US FDA
  • 6 March 2017 VAI US FDA
  • 27 February 2015 NAI US FDA
  • 13 April 2011 VAI US FDA
  • 13 November 2008 NAI US FDA

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

Registered plants

Site FDA FEI
HAVERHILL, United Kingdom Not on file
United Kingdom, United Kingdom 3002807062

What they file, and where

Molecule Regulators Docs
Sevelamer US FDA 1

Also appears on these molecule pages

Sevelamer API

Filings and GMP by regulator

Regulator Filings GMP certificates
MHRA (UK) None 6

Questions about Hvl Pharma Uk

Does Hvl Pharma Uk hold a US DMF or a CEP?
Hvl Pharma Uk holds 1 active US drug master file. 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.
Is Hvl Pharma Uk FDA-registered?
One site operated by Hvl Pharma Uk 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 Hvl Pharma Uk's last inspection go?
The most recent inspection on record closed on 3 November 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Hvl Pharma Uk manufacture?
2 registered sites are on record, in United Kingdom (Haverhill and United Kingdom). Every site is listed on this page with the register it came from.
What does Hvl Pharma Uk make?
1 molecule is on record against Hvl Pharma Uk, including Sevelamer. Each links through to that molecule's full manufacturer list.
Which regulators recognise Hvl Pharma Uk's GMP?
Current GMP certificates are on record from 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

  • The most recent inspection outcome was VAI, on 3 November 2022.

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Sources on this page

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