Suppliers / Reliable Biopharmaceutical

Reliable Biopharmaceutical

United States Updated 9 July 2026

Reliable Biopharmaceutical is an API manufacturer based in United States. It holds 3 active US drug master files across a filed portfolio of 3 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 20 August 2025 as VAI.

3
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 20 August 2025 VAI US FDA
  • 21 February 2020 VAI US FDA
  • 10 April 2015 VAI US FDA
  • 25 January 2013 VAI US FDA
  • 27 April 2012 VAI US FDA
  • 24 March 2010 VAI US FDA

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

Registered plants

Site FDA FEI
St Louis, United States Not on file
St. Louis, United States 1927156

What they file, and where

Molecule Regulators Docs
Cladribine US FDA 1
Floxuridine US FDA 1
Phentolamine US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Reliable Biopharmaceutical

Does Reliable Biopharmaceutical hold a US DMF or a CEP?
Reliable Biopharmaceutical holds 3 active US drug master files. 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 Reliable Biopharmaceutical FDA-registered?
One site operated by Reliable Biopharmaceutical carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Reliable Biopharmaceutical's last inspection go?
The most recent inspection on record closed on 20 August 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Reliable Biopharmaceutical manufacture?
2 registered sites are on record, in United States (St Louis and St. Louis). Every site is listed on this page with the register it came from.
What does Reliable Biopharmaceutical make?
3 molecules are on record against Reliable Biopharmaceutical, including Cladribine, Floxuridine and Phentolamine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Reliable Biopharmaceutical'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 VAI, on 20 August 2025.

Sources on this page

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