Suppliers / Sterling Pharma Solutions

Sterling Pharma Solutions

United Kingdom 914 employees Updated 9 July 2026

The public registers hold a second record for Sterling Pharma Solutions. The fuller profile, with 32 active US DMFs and 23 valid CEPs, is at Sterling Pharma Solutions. Figures on this page cover only this record.

Sterling Pharma Solutions is an API manufacturer based in United Kingdom. It holds one active US drug master file. Its GMP standing is certified by MHRA (UK) and US FDA. Its most recent recorded inspection, by US FDA, closed on 11 July 2025 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
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 11 July 2025 VAI US FDA
  • 16 June 2021 VAI US FDA
  • 23 June 2017 VAI US FDA
  • 7 November 2014 NAI US FDA
  • 12 May 2011 NAI US FDA

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

Registered plants

Site FDA FEI
CRAMLINGTON, United Kingdom Not on file
United Kingdom, United Kingdom 3002806719

What they file, and where

Molecule Regulators Docs
Acrivastine US FDA 1

Filings and GMP by regulator

Regulator Filings GMP certificates
MHRA (UK) None 1
US FDA None 1

Questions about Sterling Pharma Solutions

Does Sterling Pharma Solutions hold a US DMF or a CEP?
Sterling Pharma Solutions 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 Sterling Pharma Solutions FDA-registered?
One site operated by Sterling Pharma Solutions 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 Sterling Pharma Solutions's last inspection go?
The most recent inspection on record closed on 11 July 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Sterling Pharma Solutions manufacture?
2 registered sites are on record, in United Kingdom (Cramlington and United Kingdom). Every site is listed on this page with the register it came from.
What does Sterling Pharma Solutions make?
1 molecule is on record against Sterling Pharma Solutions, including Acrivastine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Sterling Pharma Solutions's GMP?
Current GMP certificates are on record from MHRA (UK) and US FDA. 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 11 July 2025.

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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