Suppliers / Chattem Chemicals

Chattem Chemicals

United States reconciled across 3 public records · 2 entities Updated 9 July 2026

Chattem Chemicals is an API manufacturer based in United States. It holds 26 active US drug master files and one valid CEP across a filed portfolio of 19 molecules. Its filings concentrate with US FDA, ARCSA (EC) and MPA (SE). Its GMP standing is certified by US FDA and EDQM. Its most recent recorded inspection, by US FDA, closed on 22 August 2025 as VAI.

26
active US DMFs
1
valid CEPs
2
registered plants 2 with an FDA FEI number
13
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 22 August 2025 VAI US FDA
  • 8 December 2022 NAI US FDA
  • 13 March 2020 VAI US FDA
  • 19 July 2018 VAI US FDA
  • 4 May 2017 NAI US FDA
  • 2 March 2017 NAI US FDA
  • 14 March 2014 NAI US FDA
  • 17 January 2014 VAI US FDA
  • 24 February 2012 NAI US FDA
  • 7 October 2011 VAI US FDA
  • 22 April 2010 NAI US FDA
  • 29 July 2009 NAI US FDA

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

Registered plants

Site FDA FEI
Chattanooga, United States 1022556
Chattanooga, United States 1000524733

What they file, and where

Molecule Regulators Docs
Dextroamphetamine US FDA 3
Amphetamine US FDA 2
Fentanyl US FDA 2
Glycine EDQM, US FDA 2
Methylphenidate US FDA 2
Ammonium Lactate US FDA 1
Benzphetamine US FDA 1
Buprenorphine US FDA 1
Butabarbital US FDA 1
Butalbital US FDA 1
Show all 19 molecules on file
Codeine US FDA 1
Dihydrocodeine US FDA 1
Hydrocodone US FDA 1
Hydromorphone US FDA 1
Hydroxyamphetamine US FDA 1
Metamfetamine US FDA 1
Methadone US FDA 1
Oxycodone US FDA 1
Sodium Oxybate US FDA 1

Also appears on these molecule pages

Amphetamine API Buprenorphine API Codeine API Dextroamphetamine API Fentanyl API Hydrocodone API Hydromorphone API Methadone API Methylphenidate API Oxycodone API Sodium Oxybate API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 10 1
ARCSA (EC) 2 None
MPA (SE) 1 None
EDQM None 1

Questions about Chattem Chemicals

Does Chattem Chemicals hold a US DMF or a CEP?
Chattem Chemicals holds 26 active US drug master files and 1 valid CEP. 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 Chattem Chemicals FDA-registered?
2 sites operated by Chattem Chemicals 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 Chattem Chemicals's last inspection go?
The most recent inspection on record closed on 22 August 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 12 inspections are on file.
Where does Chattem Chemicals manufacture?
2 registered sites are on record, in United States (Chattanooga among others). Every site is listed on this page with the register it came from.
What does Chattem Chemicals make?
19 molecules are on record against Chattem Chemicals, including Dextroamphetamine, Amphetamine, Fentanyl and Glycine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Chattem Chemicals's GMP?
Current GMP certificates are on record from US FDA and EDQM. 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

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

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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