Suppliers / Maithri Laboratories

Maithri Laboratories

India 2 duplicate records merged Updated 9 July 2026

The public registers hold a second record for Maithri Laboratories. The fuller profile, with 106 active US DMFs and 24 valid CEPs, is at Maithri Drugs. Figures on this page cover only this record.

Maithri Laboratories is an API manufacturer based in India. It holds 46 active US drug master files and 7 valid CEPs across a filed portfolio of 23 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 2 May 2025 as VAI. Customs aggregates show $1.7M of exports covering 60 molecules to 16 destinations in 2025.

46
active US DMFs
7
valid CEPs
3
registered plants 1 with an FDA FEI number
4
filings across 1 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

  • 2 May 2025 VAI US FDA
  • 31 May 2019 NAI US FDA
  • 26 June 2012 NAI US FDA

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

Registered plants

Site FDA FEI
Gaddapotharam Village, India Not on file
Sangareddy, India Not on file
Sangareddy District, India 3007800082

What they file, and where

Molecule Regulators Docs
Brivaracetam EDQM, SFDA (Saudi Arabia), US FDA 4
Eliglustat US FDA 4
Rabeprazole US FDA 4
Buspirone EDQM, US FDA 3
Flucytosine EDQM, US FDA 3
Pyridostigmine EDQM, US FDA 3
Tolterodine EDQM, US FDA 3
Apixaban US FDA 2
Betahistine US FDA 2
Chlorpromazine US FDA 2
Show all 23 molecules on file
Cysteamine US FDA 2
Daridorexant US FDA 2
Elafibranor US FDA 2
Escitalopram US FDA 2
Fesoterodine US FDA 2
Gepirone US FDA 2
Ivabradine US FDA 2
Lumateperone US FDA 2
Suvorexant US FDA 2
Valganciclovir US FDA 2
Viloxazine US FDA 2
Chlorpromazine Hydrochloride EDQM 1
Valganciclovir Hydrochloride EDQM 1

Also appears on these molecule pages

Betahistine API Brivaracetam API Buspirone API Chlorpromazine API Cysteamine API Eliglustat API Escitalopram API Fesoterodine API Flucytosine API Ivabradine API Pyridostigmine API Rabeprazole API
Show 5 more molecule pages
Suvorexant API Tolterodine API Valganciclovir API Viloxazine API Apixaban API

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 4 None
EMA None 1
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $871K 9
2025 Not reported $1.7M 16
2024 Not reported $2.4M 12
2023 Not reported $2.8M 7

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 We do not publish the identity of any buyer.

Questions about Maithri Laboratories

Does Maithri Laboratories hold a US DMF or a CEP?
Maithri Laboratories holds 46 active US drug master files and 7 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 Maithri Laboratories FDA-registered?
One site operated by Maithri 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 Maithri Laboratories's last inspection go?
The most recent inspection on record closed on 2 May 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Maithri Laboratories manufacture?
3 registered sites are on record, in India (Gaddapotharam Village, Sangareddy and Sangareddy District). Every site is listed on this page with the register it came from.
What does Maithri Laboratories make?
23 molecules are on record against Maithri Laboratories, including Brivaracetam, Eliglustat, Rabeprazole and Buspirone. Each links through to that molecule's full manufacturer list.
Which regulators recognise Maithri Laboratories's GMP?
Current GMP certificates are on record from EMA and 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 2 May 2025.

Comparable suppliers

Apitoria Pharma shares 7 molecules Hetero shares 6 molecules Zydus Lifesciences shares 6 molecules Dr Reddy's Laboratories shares 5 molecules Raks Pharma shares 5 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