Suppliers / Micro Labs

Micro Labs

India 40 employees 3 duplicate records merged Updated 9 July 2026

Micro Labs is an API and finished-dose manufacturer based in India. It holds 55 active US drug master files and 84 valid CEPs. Its filings concentrate with DAV (Vietnam), PPB (KE) and US FDA. Its GMP standing is certified by EMA, CDSCO (India) and NAFDAC (NG), among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 30 May 2025 as VAI.

55
active US DMFs
84
valid CEPs
12
registered plants 4 with an FDA FEI number
1,033
filings across 20 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
4 of 4 confirmed
Inspections
8 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

  • 30 May 2025 VAI US FDA
  • 7 February 2025 VAI US FDA
  • 3 April 2024 NAI US FDA
  • 8 December 2023 OAI US FDA
  • 12 May 2023 VAI US FDA
  • 24 January 2020 VAI US FDA
  • 16 February 2019 VAI US FDA
  • 15 February 2019 VAI US FDA

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

Registered plants

Site FDA FEI
Hosur, United Arab Emirates Not on file
Frankfurt, Germany Not on file
Frankfurt Am Main, Germany Not on file
HOSUR, India Not on file
BANGALORE, India Not on file
VERNA SALCETTE, India Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Celecoxib EDQM, US FDA 8
Brivaracetam EDQM, US FDA 5
Rivaroxaban EDQM, US FDA 5
Solifenacin Succinate EDQM, US FDA 5
Ebastine EDQM 4
Escitalopram EDQM, SFDA (Saudi Arabia), US FDA 4
Ticagrelor EDQM, SFDA (Saudi Arabia), US FDA 4
Acamprosate EDQM, US FDA 3
Bisoprolol EDQM, US FDA 3
Brimonidine EDQM, US FDA 3
Show all 30 molecules on file
Clobazam EDQM, US FDA 3
Dorzolamide EDQM, US FDA 3
Glimepiride EDQM, US FDA 3
Mirabegron EDQM, US FDA 3
Mirtazapine EDQM, US FDA 3
Naphazoline EDQM, US FDA 3
Pirfenidone EDQM, US FDA 3
Telmisartan EDQM, US FDA 3
Timolol EDQM, US FDA 3
Torasemide EDQM, US FDA 3
Cyclizine EDQM 2
Dorzolamide Hydrochloride EDQM 2
Escitalopram Oxalate EDQM 2
Ethambutol EDQM 2
Ethambutol Hydrochloride EDQM 2
Meloxicam EDQM 2
Moxifloxacin EDQM 2
Moxonidine EDQM 2
Olmesartan Medoxomil EDQM 2
Phloroglucinol EDQM 2

Also appears on these molecule pages

Show 170 more molecule pages
Arformoterol finished dose Atorvastatin finished dose Azelastine finished dose Azilsartan Medoxomil finished dose Baclofen finished dose Bempedoic Acid API Bilastine finished dose Bimatoprost finished dose Bisoprolol API Brimonidine API Brinzolamide API Brivaracetam API Bupropion finished dose Candesartan Cilexetil finished dose Carboprost finished dose Cefadroxil finished dose Cefdinir finished dose Cefepime finished dose Cefixime finished dose Cefotaxime finished dose Cefpodoxime finished dose Cefprozil finished dose Cefuroxime Axetil finished dose Celecoxib API Cephalexin finished dose Chlordiazepoxide finished dose Cholestyramine finished dose Cimetidine finished dose Cinnarizine finished dose Clavulanic Acid finished dose Clobazam API Clomipramine finished dose Clopidogrel finished dose Clozapine finished dose Colchicine finished dose Cromoglicic Acid API Dabigatran Etexilate API Dalfampridine API Dapagliflozin API Dapagliflozin Propanediol finished dose Darunavir API Dimenhydrinate finished dose Dimethyl API Diphenhydramine finished dose Dolutegravir API Dorzolamide API Doxepin finished dose Doxycycline finished dose Ebastine API Efavirenz finished dose Empagliflozin finished dose Eplerenone finished dose Escitalopram API Esomeprazole finished dose Ethionamide finished dose Etoricoxib finished dose Ezetimibe API Famotidine finished dose Febuxostat finished dose Fexofenadine finished dose Flecainide finished dose Fluorometholone finished dose Fluoxetine finished dose Flurbiprofen finished dose Formoterol finished dose Furosemide finished dose Gabapentin finished dose Glibenclamide finished dose Gliclazide finished dose Glimepiride API Glipizide finished dose Glyburide finished dose Haloperidol finished dose Hydrochlorothiazide finished dose Irbesartan API Isoniazid finished dose Isoprenaline API Itraconazole finished dose Ketorolac Tromethamine finished dose Ketotifen finished dose Lamivudine finished dose Lamotrigine finished dose Lansoprazole finished dose Latanoprost finished dose Lercanidipine finished dose Levocetirizine finished dose Levomilnacipran API Lifitegrast API Linagliptin finished dose Lisinopril finished dose Loperamide finished dose Lopinavir finished dose Lornoxicam finished dose Losartan API Lurasidone API Mavacamten API Mecobalamin finished dose Mefenamic Acid finished dose Meloxicam API Metformin finished dose Methenamine API Methocarbamol finished dose Metolazone finished dose Midazolam finished dose Milk Thistle finished dose Milnacipran finished dose Mirabegron API Mirtazapine API Moxifloxacin API Mycophenolate Mofetil finished dose Nabumetone finished dose Naphazoline API Nebivolol finished dose Nevirapine finished dose Nicotine finished dose Nitrofurantoin finished dose Nortriptyline finished dose Ofloxacin finished dose Olanzapine finished dose Olmesartan API Olmesartan Medoxomil API Olopatadine finished dose Omeprazole finished dose Orlistat finished dose Oxcarbazepine API Pentosan Polysulfate API Phloroglucinol API Pioglitazone finished dose Piracetam finished dose Pirfenidone API Potassium Clavulanate finished dose Praziquantel API Pyrazinamide finished dose Ranitidine finished dose Ranolazine finished dose Rasagiline API Riociguat API Ritonavir finished dose Rivaroxaban API Rosuvastatin finished dose Roxithromycin finished dose Rufinamide API Saxagliptin finished dose Silodosin finished dose Simvastatin finished dose Sitagliptin API Sodium Cromoglicate API Solifenacin API Succinylcholine finished dose Sulfamethoxazole finished dose Tafluprost finished dose Tamsulosin finished dose Tapentadol finished dose Telmisartan API Tenofovir Alafenamide API Tenofovir Disoproxil finished dose Ticagrelor API Timolol API Tobramycin finished dose Tofacitinib API Topiramate finished dose Torasemide API Trimetazidine finished dose Trimethoprim finished dose Ursodeoxycholic Acid finished dose Valganciclovir finished dose Varenicline finished dose Vildagliptin finished dose Vonoprazan finished dose Zidovudine finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
DAV (Vietnam) 263 None
PPB (KE) 161 None
US FDA 130 4
NAFDAC (NG) 97 6
TMDA (TZ) 70 3
DIGEMAPS (DO) 68 None
EMA None 14
CDSCO (India) None 13
MHRA (UK) None 4
ZLG (DE) None 4

Questions about Micro Labs

Does Micro Labs hold a US DMF or a CEP?
Micro Labs holds 55 active US drug master files and 84 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 Micro Labs FDA-registered?
4 sites operated by Micro Labs 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 Micro Labs's last inspection go?
The most recent inspection on record closed on 30 May 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file, of which 1 closed as OAI.
Where does Micro Labs manufacture?
12 registered sites are on record, in United Arab Emirates, Germany and India (Hosur, Frankfurt and Frankfurt Am Main among others). Every site is listed on this page with the register it came from.
What does Micro Labs make?
30 molecules are on record against Micro Labs, including Celecoxib, Brivaracetam, Rivaroxaban and Solifenacin Succinate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Micro Labs's GMP?
Current GMP certificates are on record from EMA, CDSCO (India), NAFDAC (NG), US FDA, MHRA (UK) and 2 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

  • 26 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 30 May 2025.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates