Suppliers / Noramco

Noramco

United States Updated 9 July 2026

Noramco is an API manufacturer based in United States. It holds 23 active US drug master files across a filed portfolio of 13 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 15 October 2025 as VAI.

23
active US DMFs
0
valid CEPs
1
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
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 15 October 2025 VAI US FDA
  • 18 November 2022 NAI US FDA
  • 21 February 2019 NAI US FDA
  • 17 November 2017 VAI US FDA
  • 21 January 2016 NAI US FDA
  • 13 November 2014 NAI US FDA
  • 27 April 2012 NAI US FDA
  • 2 August 2010 VAI US FDA

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

Registered plants

Site FDA FEI
Wilmington, United States 2522445

What they file, and where

Molecule Regulators Docs
Buprenorphine US FDA 4
Naloxone US FDA 3
Hydrocodone US FDA 2
Hydromorphone SFDA (Saudi Arabia), US FDA 2
Methylphenidate US FDA 2
Morphine US FDA 2
Naltrexone US FDA 2
Oxycodone US FDA 2
Codeine US FDA 1
Levorphanol US FDA 1
Show all 13 molecules on file
Methylnaltrexone US FDA 1
Oxymorphone US FDA 1
Tapentadol US FDA 1

Also appears on these molecule pages

Buprenorphine API Codeine API Hydrocodone API Hydromorphone API Methylphenidate API Morphine API Naloxone API Naltrexone API Oxycodone API Tapentadol API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Noramco

Does Noramco hold a US DMF or a CEP?
Noramco holds 23 active US drug master files. 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 Noramco FDA-registered?
One site operated by Noramco 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 Noramco's last inspection go?
The most recent inspection on record closed on 15 October 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Noramco manufacture?
1 registered site is on record, in United States (Wilmington). Every site is listed on this page with the register it came from.
What does Noramco make?
13 molecules are on record against Noramco, including Buprenorphine, Naloxone, Hydrocodone and Hydromorphone. Each links through to that molecule's full manufacturer list.
Which regulators recognise Noramco's GMP?
Current GMP certificates are on record from 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

  • 60 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 15 October 2025.

Comparable suppliers

Specgx shares 9 molecules Macfarlan Smith shares 8 molecules Veranova Lp shares 6 molecules Chattem Chemicals shares 6 molecules S,A.L.A.R.S shares 5 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