Suppliers / BioSpectra

BioSpectra

United States 149 employees Updated 9 July 2026

BioSpectra is a contract manufacturer based in United States. It holds one active US drug master file and one valid CEP across a filed portfolio of 2 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 2 February 2024 as NAI.

1
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
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 2 February 2024 NAI US FDA
  • 1 August 2017 NAI US FDA
  • 29 January 2016 NAI US FDA
  • 5 March 2015 VAI US FDA
  • 3 August 2010 NAI US FDA

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

Registered plants

Site FDA FEI
Bangor, United States Not on file
Bangor, United States 3010476065
Stroudsburg, United States 3003380159

What they file, and where

Molecule Regulators Docs
Potassium EDQM 1
Tromethamine US FDA 1

Also appears on these molecule pages

Cysteamine contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about BioSpectra

Does BioSpectra hold a US DMF or a CEP?
BioSpectra holds 1 active US drug master file 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 BioSpectra FDA-registered?
2 sites operated by BioSpectra 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 BioSpectra's last inspection go?
The most recent inspection on record closed on 2 February 2024 as NAI (No Action Indicated: nothing objectionable was found). 5 inspections are on file.
Where does BioSpectra manufacture?
3 registered sites are on record, in United States (Bangor and Stroudsburg among others). Every site is listed on this page with the register it came from.
What does BioSpectra make?
2 molecules are on record against BioSpectra, including Potassium and Tromethamine. Each links through to that molecule's full manufacturer list.
Which regulators recognise BioSpectra'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

  • The most recent inspection outcome was NAI, on 2 February 2024.

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Sources on this page

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