Suppliers / Haleos Labs

Haleos Labs

India Updated 9 July 2026

Haleos Labs is an API manufacturer based in India. It holds 4 active US drug master files 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 9 May 2025 as VAI.

4
active US DMFs
0
valid CEPs
1
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
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 9 May 2025 VAI US FDA
  • 5 April 2018 VAI US FDA

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

Registered plants

Site FDA FEI
Hyderabad, India 3005343706

What they file, and where

Molecule Regulators Docs
Allopurinol US FDA 2
Sildenafil US FDA 2

Also appears on these molecule pages

Allopurinol API Sildenafil API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Haleos Labs

Does Haleos Labs hold a US DMF or a CEP?
Haleos Labs holds 4 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 Haleos Labs FDA-registered?
One site operated by Haleos Labs 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 Haleos Labs's last inspection go?
The most recent inspection on record closed on 9 May 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Haleos Labs manufacture?
1 registered site is on record, in India (Hyderabad). Every site is listed on this page with the register it came from.
What does Haleos Labs make?
2 molecules are on record against Haleos Labs, including Allopurinol and Sildenafil. Each links through to that molecule's full manufacturer list.
Which regulators recognise Haleos Labs'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 9 May 2025.

Comparable suppliers

Hetero shares 2 molecules Matrix Pharmacorp shares 2 molecules Apitoria Pharma shares 1 molecule Dr Reddy's Laboratories shares 1 molecule Ipca Laboratories 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
EudraGMDP and national regulators
GMP certificates