Suppliers / Sterling

Sterling

Italy 132 employees Updated 9 July 2026

Sterling is an API manufacturer based in Italy. It holds 24 active US drug master files and 19 valid CEPs across a filed portfolio of 24 molecules. Its filings concentrate with INFARMED (PT), US FDA and INHRR (VE). Its GMP standing is certified by NAFDAC (NG). Its most recent recorded inspection, by US FDA, closed on 1 December 2022 as VAI.

24
active US DMFs
19
valid CEPs
4
registered plants 1 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

  • 1 December 2022 VAI US FDA
  • 20 March 2014 NAI US FDA
  • 15 November 2010 NAI US FDA

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

Registered plants

Site FDA FEI
CORCIANO, Italy Not on file
Solomeo Di Corciano, Italy Not on file
Corciano, Italy Not on file
Italy, Italy 3003042159

What they file, and where

Molecule Regulators Docs
Mometasone Furoate EDQM, US FDA 6
Norgestimate EDQM, US FDA 4
Budesonide EDQM, US FDA 3
Finasteride EDQM, SFDA (Saudi Arabia), US FDA 3
Fulvestrant EDQM, US FDA 3
Nomegestrol EDQM, US FDA 3
Ciclesonide EDQM, US FDA 2
Deflazacort SFDA (Saudi Arabia), US FDA 2
Dienogest EDQM, US FDA 2
Drospirenone EDQM, US FDA 2
Show all 24 molecules on file
Etonogestrel SFDA (Saudi Arabia), US FDA 2
Exemestane SFDA (Saudi Arabia), US FDA 2
Fluticasone Propionate EDQM, US FDA 2
Abiraterone US FDA 1
Desoxycorticosterone Pivalate US FDA 1
Dutasteride US FDA 1
Flumetasone Pivalate EDQM 1
Flunisolide US FDA 1
Fluticasone Furoate US FDA 1
Halobetasol Propionate US FDA 1
Medroxyprogesterone Acetate EDQM 1
Norelgestromin US FDA 1
Norgestrel US FDA 1
Trilostane US FDA 1

Also appears on these molecule pages

Abiraterone API Budesonide API Ciclesonide API Deflazacort API Dienogest API Drospirenone API Dutasteride API Etonogestrel API Exemestane API Finasteride API Fluticasone API Fulvestrant API
Show 5 more molecule pages
Halobetasol API Medroxyprogesterone API Mometasone API Norgestimate API Norgestrel API

Filings and GMP by regulator

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

Questions about Sterling

Does Sterling hold a US DMF or a CEP?
Sterling holds 24 active US drug master files and 19 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 FDA-registered?
One site operated by Sterling 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's last inspection go?
The most recent inspection on record closed on 1 December 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Sterling manufacture?
4 registered sites are on record, in Italy (Corciano, Solomeo Di Corciano and Corciano among others). Every site is listed on this page with the register it came from.
What does Sterling make?
24 molecules are on record against Sterling, including Mometasone Furoate, Norgestimate, Budesonide and Finasteride. Each links through to that molecule's full manufacturer list.
Which regulators recognise Sterling's GMP?
Current GMP certificates are on record from NAFDAC (NG). 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 1 December 2022.

Comparable suppliers

Industriale Chimica shares 9 molecules Cipla shares 7 molecules Newchem shares 7 molecules Curia shares 6 molecules Farmabios shares 6 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