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

Baclofen API Bisoprolol API Bumetanide API Buspirone API Dapsone API Deferasirox API Glimepiride API Raloxifene API Torasemide API Trazodone API

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 We do not publish the identity of any buyer.

Questions about Medilux Laboratories

Does Medilux Laboratories hold a US DMF or a CEP?
Medilux Laboratories holds 10 active US drug master files and 11 valid CEPs. 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 Medilux Laboratories FDA-registered?
One site operated by Medilux Laboratories 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 Medilux Laboratories's last inspection go?
The most recent inspection on record closed on 27 September 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Medilux Laboratories manufacture?
1 registered site is on record, in India (Pithampur). Every site is listed on this page with the register it came from.
What does Medilux Laboratories make?
12 molecules are on record against Medilux Laboratories, including Torasemide, Baclofen, Bisoprolol and Bumetanide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Medilux Laboratories's GMP?
Current GMP certificates are on record from US FDA and EMA. 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 27 September 2024.

Comparable suppliers

Apitoria Pharma shares 4 molecules Ipca Laboratories shares 4 molecules Piramal Pharma shares 4 molecules Hetero shares 3 molecules Alivus Life Sciences shares 3 molecules

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
Customs aggregates
Export values, molecule and destination counts