Suppliers / Medilux Laboratories

Medilux Laboratories

India 164 employees 2 duplicate records merged Updated 9 July 2026

Medilux Laboratories is an API manufacturer based in India. It holds 10 active US drug master files and 11 valid CEPs across a filed portfolio of 12 molecules. Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 27 September 2024 as VAI. Customs aggregates show $5.6M of exports covering 160 molecules to 38 destinations in 2025.

10
active US DMFs
11
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
3 of 3 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 27 September 2024 VAI US FDA
  • 27 April 2018 VAI US FDA
  • 6 August 2016 VAI US FDA

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

Registered plants

Site FDA FEI
Pithampur, India 3005594847

What they file, and where

Molecule Regulators Docs
Torasemide EDQM, SFDA (Saudi Arabia), US FDA 4
Baclofen EDQM, US FDA 2
Bisoprolol EDQM, US FDA 2
Bumetanide EDQM, US FDA 2
Buspirone EDQM, US FDA 2
Dapsone EDQM, US FDA 2
Deferasirox EDQM, US FDA 2
Glimepiride EDQM, US FDA 2
Hydroquinone SFDA (Saudi Arabia) 2
Raloxifene EDQM, US FDA 2
Show all 12 molecules on file
Trazodone EDQM, US FDA 2
M-Cresol EDQM 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1
EMA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $2.5M 21
2025 Not reported $5.6M 38
2024 Not reported $1.9M 20
2023 Not reported $2.0M 15

Export figures are customs aggregates. We do not publish the identity of any buyer.

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Open risk flags

  • The most recent inspection outcome was VAI, on 27 September 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