Suppliers / Specgx

Specgx

United States Updated 9 July 2026

Specgx is an API and finished-dose manufacturer based in United States. It holds 56 active US drug master files and 16 valid CEPs. Its filings concentrate with US FDA and INVIMA (CO). Its GMP standing is certified by US FDA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 22 October 2025 as VAI.

56
active US DMFs
16
valid CEPs
6
registered plants 5 with an FDA FEI number
138
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
5 of 5 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 22 October 2025 VAI US FDA
  • 22 September 2025 VAI US FDA
  • 18 September 2023 VAI US FDA
  • 11 February 2022 NAI US FDA
  • 16 March 2020 NAI US FDA
  • 13 March 2020 NAI US FDA
  • 12 September 2019 VAI US FDA
  • 6 March 2019 NAI US FDA

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

Registered plants

Site FDA FEI
GREENVILLE, United States Not on file
Hobart, United States 1317295
Webster Groves, United States 3005275960
Greenville, United States 1419579
Raleigh, United States 1021320
St. Louis, United States 1940521

What they file, and where

Molecule Regulators Docs
Buprenorphine EDQM, US FDA 6
Sufentanil EDQM, US FDA 6
Acetaminophen EDQM, SFDA (Saudi Arabia), US FDA 5
Dextroamphetamine US FDA 5
Fentanyl EDQM, SFDA (Saudi Arabia), US FDA 5
Methylphenidate EDQM, SFDA (Saudi Arabia), US FDA 5
Codeine EDQM, SFDA (Saudi Arabia), US FDA 4
Hydrocodone US FDA 4
Naltrexone EDQM, US FDA 3
Oxycodone EDQM, US FDA 3
Show all 30 molecules on file
Amphetamine US FDA 2
Chlorpheniramine US FDA 2
Hydromorphone SFDA (Saudi Arabia), US FDA 2
Levorphanol US FDA 2
Methadone US FDA 2
Morphine SFDA (Saudi Arabia), US FDA 2
Nalbuphine US FDA 2
Nalmefene US FDA 2
Naloxone SFDA (Saudi Arabia), US FDA 2
Noscapine US FDA 2
Oxymorphone US FDA 2
Cocaine US FDA 1
Dexamfetamine Sulfate EDQM 1
Dexmethylphenidate US FDA 1
Dextromethadone US FDA 1
Diphenoxylate US FDA 1
Ioversol US FDA 1
Meperidine US FDA 1
Methylnaltrexone US FDA 1
Methylphenidate Hydrochloride EDQM 1

Also appears on these molecule pages

Acetaminophen API Amphetamine API Buprenorphine API Chlorphenamine API Chlorpheniramine API Clomipramine finished dose Codeine API Dexmethylphenidate API Dextroamphetamine API Fentanyl API Hydrocodone API Hydromorphone API
Show 10 more molecule pages
Methadone API Methylphenidate API Morphine API Naloxone API Naltrexone API Nortriptyline finished dose Oxycodone API Paracetamol API Prucalopride finished dose Vigabatrin finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 136 3
INVIMA (CO) 2 None
ANVISA (Brazil) None 1

Questions about Specgx

Does Specgx hold a US DMF or a CEP?
Specgx holds 56 active US drug master files and 16 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 Specgx FDA-registered?
5 sites operated by Specgx 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 Specgx's last inspection go?
The most recent inspection on record closed on 22 October 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Specgx manufacture?
6 registered sites are on record, in United States (Greenville, Hobart and Webster Groves among others). Every site is listed on this page with the register it came from.
What does Specgx make?
30 molecules are on record against Specgx, including Buprenorphine, Sufentanil, Acetaminophen and Dextroamphetamine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Specgx's GMP?
Current GMP certificates are on record from US FDA and ANVISA (Brazil). 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

  • 20 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 22 October 2025.

Comparable suppliers

Veranova Lp shares 10 molecules Chattem Chemicals shares 10 molecules Macfarlan Smith shares 10 molecules Noramco shares 9 molecules Cambrex Charles City 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