Suppliers / MSN Laboratories

MSN Laboratories

India reconciled across 33 public records · 16 entities Updated 9 July 2026

MSN Laboratories is an API and finished-dose manufacturer based in India. It holds 517 active US drug master files and 121 valid CEPs. Its filings concentrate with ARCSA (EC), MHRA (UK) and CDSCO (India). Its GMP standing is certified by EDQM, EMA and ANVISA (Brazil), among 12 authorities. Its most recent recorded inspection, by US FDA, closed on 13 March 2026 as NAI. Customs aggregates show $231.3M of exports covering 3,882 molecules to 89 destinations in 2025.

517
active US DMFs
121
valid CEPs
36
registered plants 12 with an FDA FEI number
1,433
filings across 29 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
5 of 8 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

  • 13 March 2026 NAI US FDA
  • 9 May 2025 VAI US FDA
  • 6 December 2024 NAI US FDA
  • 13 September 2024 VAI US FDA
  • 25 June 2024 VAI US FDA
  • 22 March 2024 VAI US FDA
  • 21 December 2023 VAI US FDA
  • 21 April 2023 VAI US FDA
  • 31 March 2023 VAI US FDA
  • 31 March 2023 NAI US FDA
  • 8 December 2022 NAI US FDA
  • 3 June 2022 VAI US FDA

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

Registered plants

Site FDA FEI
Rangareddy, United Arab Emirates Not on file
Telangana, Colombia Not on file
HITCHIN, United Kingdom Not on file
LETCHWORTH GARDEN CITY, United Kingdom Not on file
Kardanur Village, India Not on file
Kandi Mandal, India Not on file

30 further sites are on record.

What they file, and where

Molecule Regulators Docs
Dapagliflozin SFDA (Saudi Arabia), US FDA 10
Esomeprazole EDQM, SFDA (Saudi Arabia), US FDA 10
Sitagliptin EDQM, SFDA (Saudi Arabia), US FDA 9
Rosuvastatin EDQM, SFDA (Saudi Arabia), US FDA 7
Clopidogrel EDQM, SFDA (Saudi Arabia), US FDA 6
Mebendazole EDQM, US FDA 6
Metoprolol EDQM, US FDA 6
Pantoprazole EDQM, SFDA (Saudi Arabia), US FDA 6
Posaconazole SFDA (Saudi Arabia), US FDA 6
Pregabalin EDQM, SFDA (Saudi Arabia), US FDA 6
Show all 40 molecules on file
Rivastigmine EDQM, US FDA 6
Ruxolitinib SFDA (Saudi Arabia), US FDA 6
Sacubitril SFDA (Saudi Arabia), US FDA 6
Atorvastatin SFDA (Saudi Arabia), US FDA 5
Bosutinib SFDA (Saudi Arabia), US FDA 5
Carboprost EDQM, SFDA (Saudi Arabia), US FDA 5
Carfilzomib SFDA (Saudi Arabia), US FDA 5
Eplerenone EDQM, SFDA (Saudi Arabia), US FDA 5
Ezetimibe PMDA (Japan), SFDA (Saudi Arabia), US FDA 5
Gefitinib EDQM, SFDA (Saudi Arabia), US FDA 5
Moxifloxacin SFDA (Saudi Arabia), US FDA 5
Nilotinib SFDA (Saudi Arabia), US FDA 5
Pirfenidone EDQM, SFDA (Saudi Arabia), US FDA 5
Riociguat EDQM, SFDA (Saudi Arabia), US FDA 5
Tadalafil EDQM, SFDA (Saudi Arabia), US FDA 5
Teriflunomide EDQM, SFDA (Saudi Arabia), US FDA 5
Ticagrelor EDQM, SFDA (Saudi Arabia), US FDA 5
Tofacitinib SFDA (Saudi Arabia), US FDA 5
Vigabatrin EDQM, US FDA 5
Abiraterone SFDA (Saudi Arabia), US FDA 4
Apremilast US FDA 4
Cabozantinib US FDA 4
Capecitabine EDQM, SFDA (Saudi Arabia), US FDA 4
Clobazam EDQM, SFDA (Saudi Arabia), US FDA 4
Clopidogrel Hydrogen Sulfate EDQM 4
Dasatinib SFDA (Saudi Arabia), US FDA 4
Deferasirox EDQM, SFDA (Saudi Arabia), US FDA 4
Docetaxel EDQM, US FDA 4
Duloxetine EDQM, SFDA (Saudi Arabia), US FDA 4
Dutasteride EDQM, SFDA (Saudi Arabia), US FDA 4

Also appears on these molecule pages

Show 197 more molecule pages
Aprepitant finished dose Arformoterol API Atorvastatin finished dose Avanafil API Axitinib API Azacitidine API Azelastine API Azilsartan Medoxomil API Baloxavir Marboxil API Baricitinib API Bempedoic Acid finished dose Bendamustine API Bexarotene API Bicalutamide API Bilastine finished dose Bimatoprost API Bortezomib API Bosentan API Bosutinib API Brivaracetam finished dose Bumetanide API Cabazitaxel API Cabozantinib API Capecitabine API Carboprost API Carfilzomib API Cariprazine API Carmustine API Caspofungin finished dose Cladribine API Clevidipine API Clobazam finished dose Clofarabine API Clonazepam finished dose Clopidogrel API Crizotinib API Cyclophosphamide API Dabigatran API Dabigatran Etexilate Mesilate API Dapagliflozin API Dapagliflozin Propanediol API Dapoxetine finished dose Darolutamide API Darunavir finished dose Dasatinib API Decitabine API Deferasirox API Deucravacitinib API Dexlansoprazole API Dexrazoxane API Diazoxide API Dimethyl finished dose Docetaxel API Dofetilide finished dose Dronedarone API Duloxetine API Dutasteride API Edaravone API Elagolix finished dose Eltrombopag API Empagliflozin finished dose Enzalutamide API Eplerenone API Erlotinib API Ertugliflozin API Esmolol API Everolimus API Ezetimibe API Favipiravir finished dose Febuxostat finished dose Fesoterodine finished dose Finasteride API Fingolimod API Formoterol API Fosaprepitant API Gadobutrol finished dose Gefitinib API Gemcitabine API Glimepiride finished dose Glycerol Phenylbutyrate API Ibrutinib API Icatibant finished dose Iloprost API Imatinib API Imatinib Mesilate API Isosulfan Blue API Ivabradine finished dose Ivacaftor API Ketorolac Tromethamine API Lacosamide finished dose Lapatinib API Latanoprost API Latanoprostene Bunod API Lenalidomide API Lenvatinib API Levocetirizine finished dose Levofloxacin finished dose Levothyroxine API Linagliptin finished dose Lubiprostone API Lurasidone finished dose Lurbinectedin API Macitentan finished dose Metformin finished dose Methotrexate API Midostaurin API Mirabegron API Molnupiravir API Montelukast finished dose Moxifloxacin finished dose Naftifine API Nebivolol finished dose Nelarabine API Neostigmine API Nicardipine API Nilotinib API Nintedanib API Niraparib API Obeticholic Acid finished dose Olaparib API Olmesartan API Olmesartan Medoxomil API Olopatadine API Oseltamivir finished dose Paclitaxel API Palbociclib API Paliperidone API Palonosetron API Pantoprazole API Pazopanib API Pemetrexed API Pemetrexed Disodium API Perampanel finished dose Phylloquinone API Pirfenidone finished dose Pitavastatin API Pitolisant API Plecanatide finished dose Plerixafor API Pomalidomide API Posaconazole API Pramipexole API Prasugrel API Pregabalin finished dose Prucalopride API Ramelteon API Ranolazine finished dose Regorafenib API Relugolix API Revefenacin API Ribociclib API Rifaximin API Riociguat finished dose Rivaroxaban API Roflumilast API Rosuvastatin API Rufinamide API Ruxolitinib API Sacubitril finished dose Sacubitril/Valsartan finished dose Safinamide finished dose Salmeterol API Selexipag API Silodosin API Solifenacin API Sorafenib API Sugammadex finished dose Sunitinib API Tafamidis API Tafluprost API Tamoxifen finished dose Telmisartan finished dose Terbinafine API Teriflunomide API Thiotepa API Ticagrelor finished dose Tipiracil API Tofacitinib API Tolvaptan API Trabectedin API Tramadol finished dose Trametinib API Travoprost API Treprostinil API Trifluridine API Trospium API Upadacitinib API Varenicline API Venetoclax API Vigabatrin API Vilanterol API Vildagliptin finished dose Vismodegib API Voriconazole API Vortioxetine finished dose Zileuton API Zopiclone finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 147 None
MHRA (UK) 140 5
CDSCO (India) 125 2
DIGEMAPS (DO) 104 None
US FDA 103 6
TMDA (TZ) 94 None
EDQM None 30
EMA None 13
ANVISA (Brazil) None 10
MFDS (Korea) None 6
UZPHARM (UZ) None 2
FDA (GH) None 1
NAFDAC (NG) None 1
EAEU_EEC None 1
INVIMA (CO) None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $106.8M 93
2025 Not reported $231.3M 89
2024 Not reported $207.9M 82
2023 Not reported $214.7M 78

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

Questions about MSN Laboratories

Does MSN Laboratories hold a US DMF or a CEP?
MSN Laboratories holds 517 active US drug master files and 121 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 MSN Laboratories FDA-registered?
12 sites operated by MSN Laboratories 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 MSN Laboratories's last inspection go?
The most recent inspection on record closed on 13 March 2026 as NAI (No Action Indicated: nothing objectionable was found). 24 inspections are on file.
Where does MSN Laboratories manufacture?
36 registered sites are on record, in United Arab Emirates, Colombia, United Kingdom and India (Rangareddy, Telangana and Hitchin among others). Every site is listed on this page with the register it came from.
What does MSN Laboratories make?
40 molecules are on record against MSN Laboratories, including Dapagliflozin, Esomeprazole, Sitagliptin and Rosuvastatin. Each links through to that molecule's full manufacturer list.
Which regulators recognise MSN Laboratories's GMP?
Current GMP certificates are on record from EDQM, EMA, ANVISA (Brazil), US FDA, MFDS (Korea) and 7 more. 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 NAI, on 13 March 2026.

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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