Suppliers / J.M. Huber Micropowders

J.M. Huber Micropowders

United States Updated 9 July 2026

J.M. Huber Micropowders is an API manufacturer based in United States. It holds 4 active US drug master files and one valid CEP across a filed portfolio of 2 molecules. Its most recent recorded inspection, by US FDA, closed on 5 December 2025 as OAI.

4
active US DMFs
1
valid CEPs
3
registered plants 2 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 5 December 2025 OAI US FDA
  • 27 August 2021 VAI US FDA
  • 25 June 2021 VAI US FDA
  • 10 August 2018 OAI US FDA
  • 12 September 2017 NAI US FDA
  • 17 December 2014 VAI US FDA
  • 30 October 2014 NAI US FDA
  • 18 January 2012 VAI US FDA

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

Registered plants

Site FDA FEI
Atlanta, United States Not on file
Quincy, United States 3002981536
La Mirada, United States 3003665718

What they file, and where

Molecule Regulators Docs
Calcium US FDA 3
Calcium Carbonate EDQM, US FDA 2

Also appears on these molecule pages

Calcium Carbonate API

Questions about J.M. Huber Micropowders

Does J.M. Huber Micropowders hold a US DMF or a CEP?
J.M. Huber Micropowders holds 4 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 J.M. Huber Micropowders FDA-registered?
2 sites operated by J.M. Huber Micropowders 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 J.M. Huber Micropowders's last inspection go?
The most recent inspection on record closed on 5 December 2025 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 8 inspections are on file, of which 2 closed as OAI.
Where does J.M. Huber Micropowders manufacture?
3 registered sites are on record, in United States (Atlanta, Quincy and La Mirada). Every site is listed on this page with the register it came from.
What does J.M. Huber Micropowders make?
2 molecules are on record against J.M. Huber Micropowders, including Calcium and Calcium Carbonate. Each links through to that molecule's full manufacturer list.

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 OAI, on 5 December 2025.

Comparable suppliers

Emnar Pharma shares 1 molecule Omya International shares 1 molecule Mochen Pharmaceutical (Hubei) shares 1 molecule Mineraria Sacilese shares 1 molecule Scora shares 1 molecule

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