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
VERNA SALCETTE, India Not on file
HOSUR, India Not on file
BANGALORE, 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 91 more molecule pages
Cefdinir finished dose Cefixime finished dose Cefuroxime Axetil finished dose Celecoxib API Cephalexin finished dose Cetirizine finished dose Clarithromycin finished dose Clavulanic Acid finished dose Clopidogrel finished dose Dapagliflozin API Dimenhydrinate finished dose Diphenhydramine finished dose Dolutegravir API Doxycycline finished dose Empagliflozin finished dose Eplerenone finished dose Escitalopram API Esomeprazole finished dose Etoricoxib finished dose Ezetimibe API Famotidine finished dose Febuxostat finished dose Fexofenadine finished dose Fluorometholone finished dose Fluoxetine finished dose Formoterol finished dose Furosemide finished dose Gabapentin finished dose Glibenclamide finished dose Gliclazide finished dose Glimepiride API Haloperidol finished dose Hydrochlorothiazide finished dose Irbesartan API Isoniazid finished dose Itraconazole finished dose Ketorolac Tromethamine finished dose Lamivudine finished dose Lamotrigine finished dose Lansoprazole finished dose Latanoprost finished dose Levocetirizine finished dose Linagliptin finished dose Lisinopril finished dose Loperamide finished dose Losartan API Mefenamic Acid finished dose Meloxicam API Metformin finished dose Midazolam finished dose Mirabegron API Mirtazapine API Moxifloxacin API Mycophenolate Mofetil finished dose Nabumetone finished dose Nebivolol finished dose Nicotine finished dose Nitrofurantoin finished dose Ofloxacin finished dose Olanzapine finished dose Olmesartan API Olmesartan Medoxomil API Olopatadine finished dose Omeprazole finished dose Oxcarbazepine API Pioglitazone finished dose Piracetam finished dose Praziquantel API Pyrazinamide finished dose Ranitidine finished dose Ritonavir finished dose Rivaroxaban API Rosuvastatin finished dose Roxithromycin finished dose Saxagliptin finished dose Simvastatin finished dose Sitagliptin API Solifenacin API Sulfamethoxazole finished dose Tafluprost finished dose Tamsulosin finished dose Telmisartan API Tenofovir Disoproxil finished dose Ticagrelor API Timolol API Tobramycin finished dose Topiramate finished dose Trimetazidine finished dose Trimethoprim finished dose Ursodeoxycholic Acid finished dose Vildagliptin 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
ZLG (DE) None 4
MHRA (UK) None 4

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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