Suppliers / Maithri Drugs

Maithri Drugs

India 231 employees reconciled across 3 public records · 3 entities Updated 9 July 2026

Maithri Drugs is an API manufacturer based in India. It holds 106 active US drug master files and 24 valid CEPs. Its GMP standing is certified by EDQM, EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 20 June 2025 as VAI. Customs aggregates show $7.3M of exports covering 228 molecules to 37 destinations in 2025.

106
active US DMFs
24
valid CEPs
6
registered plants 2 with an FDA FEI number
6
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

  • 20 June 2025 VAI US FDA
  • 2 May 2025 VAI US FDA
  • 22 November 2019 VAI US FDA
  • 31 May 2019 NAI US FDA
  • 25 August 2017 VAI 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
Bonthapally Village, India Not on file
Gaddapotharam Village, India Not on file
Sangareddy District, India 3012234942
Bonthapally, India Not on file
Sangareddy District, India 3007800082
Sangareddy, India Not on file

What they file, and where

Molecule Regulators Docs
Nitrofurantoin EDQM, US FDA 5
Selexipag SFDA (Saudi Arabia), US FDA 5
Brivaracetam EDQM, SFDA (Saudi Arabia), US FDA 4
Mirtazapine EDQM, US FDA 4
Buspirone EDQM, US FDA 3
Flucytosine EDQM, US FDA 3
Pyridostigmine EDQM, US FDA 3
Tolterodine EDQM, US FDA 3
Adapalene EDQM, US FDA 2
Brimonidine EDQM, US FDA 2
Show all 40 molecules on file
Carbidopa EDQM, US FDA 2
Carbimazole EDQM, US FDA 2
Chlorpromazine Hydrochloride EDQM 2
Chlorthalidone EDQM, US FDA 2
Dapoxetine SFDA (Saudi Arabia), US FDA 2
Daridorexant US FDA 2
Doxycycline US FDA 2
Eliglustat US FDA 2
Esketamine EDQM, US FDA 2
Foscarnet EDQM, US FDA 2
Ketamine EDQM, US FDA 2
Lercanidipine US FDA 2
Lercanidipine Hydrochloride EDQM 2
Levodopa EDQM, US FDA 2
Lithium Cation US FDA 2
Mesalazine EDQM, US FDA 2
Methimazole EDQM, US FDA 2
Potassium US FDA 2
Rabeprazole US FDA 2
Valganciclovir Hydrochloride EDQM 2
Viloxazine US FDA 2
Voriconazole US FDA 2
Abrocitinib US FDA 1
Apixaban US FDA 1
Avacopan US FDA 1
Besifloxacin US FDA 1
Betahistine US FDA 1
Cenobamate US FDA 1
Chlorpromazine US FDA 1
Cysteamine US FDA 1

Also appears on these molecule pages

Adapalene API Brimonidine API Carbidopa API Carbimazole API Cenobamate API Chlorthalidone API Dapoxetine API Deutetrabenazine API Dexmedetomidine API Docosanol API Doxycycline API Efinaconazole API
Show 28 more molecule pages
Esketamine API Finerenone API Foscarnet API Gemcitabine API Ivacaftor API Ketamine API Lercanidipine API Levodopa API Mavacamten API Mesalamine API Mesalazine API Methimazole API Mirtazapine API Nitrofurantoin API Ospemifene API Ozanimod API Penciclovir API Raltegravir API Selexipag API Siponimod API Tigecycline API Trospium API Varenicline API Vericiguat API Viloxazine API Vonoprazan API Voriconazole API Zonisamide API

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 10 None
EDQM None 24
EMA None 3
US FDA None 2

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $1.6M 18
2025 Not reported $7.3M 37
2024 Not reported $4.5M 41
2023 Not reported $5.7M 33

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

Questions about Maithri Drugs

Does Maithri Drugs hold a US DMF or a CEP?
Maithri Drugs holds 106 active US drug master files and 24 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 Drugs FDA-registered?
2 sites operated by Maithri Drugs 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 Maithri Drugs's last inspection go?
The most recent inspection on record closed on 20 June 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Maithri Drugs manufacture?
6 registered sites are on record, in India (Bonthapally Village, Gaddapotharam Village and Sangareddy District among others). Every site is listed on this page with the register it came from.
What does Maithri Drugs make?
40 molecules are on record against Maithri Drugs, including Nitrofurantoin, Selexipag, Brivaracetam and Mirtazapine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Maithri Drugs's GMP?
Current GMP certificates are on record from EDQM, 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 20 June 2025.

Comparable suppliers

Apitoria Pharma shares 15 molecules Hetero shares 12 molecules Macleods Pharmaceuticals shares 10 molecules Alivus Life Sciences shares 9 molecules Lee Pharma shares 8 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