Suppliers / Sterling Pharma Solutions

Sterling Pharma Solutions

Malta 64 employees reconciled across 7 public records · 5 entities Updated 9 July 2026

Sterling Pharma Solutions is an API manufacturer based in Malta. It holds 32 active US drug master files and 23 valid CEPs across a filed portfolio of 28 molecules. Its filings concentrate with INFARMED (PT), US FDA and INHRR (VE). Its GMP standing is certified by NAFDAC (NG), US FDA and MHRA (UK). Its most recent recorded inspection, by US FDA, closed on 11 July 2025 as VAI.

32
active US DMFs
23
valid CEPs
10
registered plants 5 with an FDA FEI number
30
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 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
  • 1 December 2022 VAI US FDA
  • 1 September 2022 VAI US FDA
  • 5 April 2022 VAI US FDA
  • 16 June 2021 VAI US FDA
  • 13 November 2019 VAI US FDA
  • 13 September 2019 VAI US FDA
  • 4 April 2018 VAI US FDA
  • 23 June 2017 VAI US FDA
  • 3 February 2017 NAI US FDA
  • 20 November 2015 NAI US FDA
  • 23 April 2015 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
Ireland, Ireland 3002807776
CORCIANO, Italy Not on file
Corciano, Italy Not on file
Solomeo Di Corciano, Italy Not on file

4 further sites are on record.

What they file, and where

Molecule Regulators Docs
Mometasone Furoate EDQM, US FDA 6
Dutasteride EDQM, SFDA (Saudi Arabia), US FDA 5
Fulvestrant EDQM, SFDA (Saudi Arabia), US FDA 5
Norgestimate EDQM, US FDA 4
Budesonide EDQM, US FDA 3
Drospirenone EDQM, US FDA 3
Finasteride EDQM, SFDA (Saudi Arabia), US FDA 3
Levonorgestrel EDQM, US FDA 3
Nomegestrol EDQM, US FDA 3
Abiraterone US FDA 2
Show all 28 molecules on file
Ciclesonide EDQM, US FDA 2
Deflazacort SFDA (Saudi Arabia), US FDA 2
Dienogest EDQM, US FDA 2
Etonogestrel SFDA (Saudi Arabia), US FDA 2
Exemestane SFDA (Saudi Arabia), US FDA 2
Fluticasone Furoate SFDA (Saudi Arabia), US FDA 2
Fluticasone Propionate EDQM, US FDA 2
Acrivastine US FDA 1
Desoxycorticosterone Pivalate US FDA 1
Flumetasone Pivalate EDQM 1
Flunisolide US FDA 1
Halobetasol Propionate US FDA 1
Medroxyprogesterone Acetate EDQM 1
Norelgestromin US FDA 1
Norgestrel US FDA 1
Trilostane US FDA 1
Umeclidinium Bromide US FDA 1
Vilanterol US FDA 1

Also appears on these molecule pages

Abiraterone API Drospirenone API Dutasteride API Fulvestrant API Levonorgestrel API Umeclidinium API Vilanterol API

Filings and GMP by regulator

Regulator Filings GMP certificates
INFARMED (PT) 28 None
US FDA 1 1
INHRR (VE) 1 None
NAFDAC (NG) None 2
MHRA (UK) None 1

Questions about Sterling Pharma Solutions

Does Sterling Pharma Solutions hold a US DMF or a CEP?
Sterling Pharma Solutions holds 32 active US drug master files and 23 valid CEPs. 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?
5 sites operated by Sterling Pharma Solutions 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 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). 19 inspections are on file.
Where does Sterling Pharma Solutions manufacture?
10 registered sites are on record, in United Kingdom, Ireland, Italy and Malta (Cramlington, United Kingdom and Ireland among others). Every site is listed on this page with the register it came from.
What does Sterling Pharma Solutions make?
28 molecules are on record against Sterling Pharma Solutions, including Mometasone Furoate, Dutasteride, Fulvestrant and Norgestimate. 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 NAFDAC (NG), US FDA and 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 11 July 2025.

Comparable suppliers

Cipla shares 4 molecules Lupin shares 4 molecules Industriale Chimica shares 4 molecules Sterling shares 4 molecules MSN Laboratories shares 3 molecules

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