Suppliers / Wanbury

Wanbury

India WANBURY.BO 2 duplicate records merged Updated 9 July 2026

Wanbury is an API manufacturer based in India. It holds 19 active US drug master files across a filed portfolio of 12 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 14 June 2024 as NAI. Customs aggregates show $57.8M of exports covering 888 molecules to 56 destinations in 2025.

19
active US DMFs
0
valid CEPs
2
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

  • 14 June 2024 NAI US FDA
  • 2 March 2018 VAI US FDA
  • 29 September 2016 VAI US FDA
  • 1 July 2016 VAI US FDA
  • 9 May 2013 NAI US FDA
  • 3 August 2012 NAI US FDA
  • 30 October 2009 VAI US FDA
  • 18 February 2009 VAI US FDA

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

Registered plants

Site FDA FEI
Tanuku, India 3002980818
Dist-Raigad, India 3003227148

What they file, and where

Molecule Regulators Docs
Metformin SFDA (Saudi Arabia), US FDA 7
Diphenhydramine SFDA (Saudi Arabia), US FDA 3
Paroxetine US FDA 2
Sertraline US FDA 2
Dextromethorphan US FDA 1
Hydralazine US FDA 1
Imiquimod US FDA 1
Methoxsalen US FDA 1
Quetiapine US FDA 1
Rivaroxaban US FDA 1
Show all 12 molecules on file
Salsalate US FDA 1
Tramadol US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $9.8M 34
2025 Not reported $57.8M 56
2024 $75.3M $43.3M 50
2023 $72.7M $37.9M 56
2022 $73.5M Not reported Not reported

Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.

Questions about Wanbury

Does Wanbury hold a US DMF or a CEP?
Wanbury holds 19 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 Wanbury FDA-registered?
2 sites operated by Wanbury 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 Wanbury's last inspection go?
The most recent inspection on record closed on 14 June 2024 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Wanbury manufacture?
2 registered sites are on record, in India (Tanuku and Dist-raigad). Every site is listed on this page with the register it came from.
What does Wanbury make?
12 molecules are on record against Wanbury, including Metformin, Diphenhydramine, Paroxetine and Sertraline. Each links through to that molecule's full manufacturer list.
Which regulators recognise Wanbury'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

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was NAI, on 14 June 2024.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates
Customs aggregates
Export values, molecule and destination counts
Company filings
Revenue as reported