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.

active US DMFs

valid CEPs

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
Raleigh, United States	1021320
Greenville, United States	1419579
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

Chlorphenamine API Chlorpheniramine API Codeine API Naltrexone 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

Comparing suppliers?

Choose your molecules and target markets. Specgx comes back tiered against every other supplier able to file there.

Start for free

No sales call.

Open risk flags

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

Sources on this page

FDA: Drug master files, establishment registration, inspection classifications
EDQM: Certificates of suitability
EudraGMDP and national regulators: GMP certificates