Suppliers / Neuland Laboratories

Neuland Laboratories

India NEULANDLAB.BO 2 duplicate records merged Updated 9 July 2026

Neuland Laboratories is an API manufacturer based in India. It holds 148 active US drug master files and 31 valid CEPs. Its filings concentrate with NCELS (KZ) and MINSA (CR). Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 2 May 2025 as VAI. Customs aggregates show $111.5M of exports covering 858 molecules to 55 destinations in 2025.

148
active US DMFs
31
valid CEPs
4
registered plants 3 with an FDA FEI number
6
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 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

  • 2 May 2025 VAI US FDA
  • 22 March 2024 NAI US FDA
  • 26 May 2023 VAI US FDA
  • 7 February 2020 VAI US FDA
  • 21 June 2019 VAI US FDA
  • 30 November 2018 NAI US FDA
  • 7 April 2017 VAI US FDA
  • 7 August 2015 VAI US FDA

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

Registered plants

Site FDA FEI
Hyderabad, India Not on file
Sangareddy, India 3003309323
Sangareddy District, India 3008765255
Sangareddy District, India 3003289270

What they file, and where

Molecule Regulators Docs
Enalapril EDQM, SFDA (Saudi Arabia), US FDA 9
Brinzolamide US FDA 8
Ciprofloxacin EDQM, SFDA (Saudi Arabia), US FDA 8
Dorzolamide EDQM, SFDA (Saudi Arabia), US FDA 8
Mirtazapine EDQM, SFDA (Saudi Arabia), US FDA 8
Albuterol EDQM, SFDA (Saudi Arabia), US FDA 6
Aripiprazole EDQM, SFDA (Saudi Arabia), US FDA 6
Donepezil EDQM, SFDA (Saudi Arabia), US FDA 6
Apixaban SFDA (Saudi Arabia), US FDA 5
Entacapone EDQM, SFDA (Saudi Arabia), US FDA 5
Show all 30 molecules on file
Linezolid SFDA (Saudi Arabia), US FDA 5
Dabigatran Etexilate US FDA 4
Deferasirox EDQM, SFDA (Saudi Arabia), US FDA 4
Ipratropium EDQM, SFDA (Saudi Arabia), US FDA 4
Labetalol EDQM, SFDA (Saudi Arabia), US FDA 4
Levetiracetam EDQM, SFDA (Saudi Arabia), US FDA 4
Levofloxacin EDQM, SFDA (Saudi Arabia), US FDA 4
Olanzapine EDQM, SFDA (Saudi Arabia), US FDA 4
Paliperidone US FDA 4
Paricalcitol SFDA (Saudi Arabia), US FDA 4
Propofol EDQM, SFDA (Saudi Arabia), US FDA 4
Rivaroxaban EDQM, SFDA (Saudi Arabia), US FDA 4
Ropinirole US FDA 4
Salmeterol EDQM, SFDA (Saudi Arabia), US FDA 4
Tafamidis US FDA 4
Voriconazole EDQM, SFDA (Saudi Arabia), US FDA 4
Voxelotor US FDA 4
Escitalopram EDQM, US FDA 3
Ezetimibe SFDA (Saudi Arabia), US FDA 3
Mirabegron EDQM, US FDA 3

Also appears on these molecule pages

Albuterol contract manufacturing Alcaftadine contract manufacturing Apixaban contract manufacturing Apremilast contract manufacturing Aripiprazole contract manufacturing Betahistine API Bosentan contract manufacturing Brinzolamide API Ciprofloxacin contract manufacturing Citalopram contract manufacturing Dabigatran contract manufacturing Deferasirox contract manufacturing
Show 54 more molecule pages
Dexlansoprazole contract manufacturing Difelikefalin API Dimethyl contract manufacturing Domperidone contract manufacturing Donepezil contract manufacturing Dorzolamide API Edaravone contract manufacturing Edoxaban API Elagolix contract manufacturing Enalapril contract manufacturing Entacapone contract manufacturing Escitalopram contract manufacturing Esomeprazole contract manufacturing Ezetimibe contract manufacturing Hydralazine contract manufacturing Indacaterol contract manufacturing Ipratropium contract manufacturing Itraconazole contract manufacturing Ivabradine contract manufacturing Labetalol contract manufacturing Lansoprazole contract manufacturing Levetiracetam contract manufacturing Levofloxacin contract manufacturing Linezolid contract manufacturing Lurasidone contract manufacturing Lysine contract manufacturing Mirabegron API Mirtazapine contract manufacturing Moxifloxacin contract manufacturing Ofloxacin contract manufacturing Olanzapine contract manufacturing Omeprazole contract manufacturing Paliperidone contract manufacturing Palonosetron API Paricalcitol API Posaconazole contract manufacturing Propofol contract manufacturing Ramipril contract manufacturing Ranitidine API Rivaroxaban contract manufacturing Ropinirole contract manufacturing Rotigotine contract manufacturing Salbutamol contract manufacturing Salmeterol contract manufacturing Sotalol contract manufacturing Sugammadex contract manufacturing Tafamidis API Tamsulosin contract manufacturing Ticagrelor contract manufacturing Vilanterol API Vonoprazan API Voriconazole contract manufacturing Voxelotor API Dabigatran Etexilate API

Filings and GMP by regulator

Regulator Filings GMP certificates
NCELS (KZ) 3 None
MINSA (CR) 3 None
US FDA None 3
EMA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $10.7M 34
2025 $169.5M $111.5M 55
2024 $186.3M $124.0M 60
2023 $144.2M $103.0M 69

Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.

Questions about Neuland Laboratories

Does Neuland Laboratories hold a US DMF or a CEP?
Neuland Laboratories holds 148 active US drug master files and 31 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 Neuland Laboratories FDA-registered?
3 sites operated by Neuland 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 Neuland 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). 8 inspections are on file.
Where does Neuland Laboratories manufacture?
4 registered sites are on record, in India (Hyderabad, Sangareddy and Sangareddy District among others). Every site is listed on this page with the register it came from.
What does Neuland Laboratories make?
30 molecules are on record against Neuland Laboratories, including Enalapril, Brinzolamide, Ciprofloxacin and Dorzolamide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Neuland Laboratories's GMP?
Current GMP certificates are on record from US FDA and EMA. 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

  • 3 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 2 May 2025.

Comparable suppliers

Dr Reddy's Laboratories shares 28 molecules Apitoria Pharma shares 21 molecules Cipla shares 19 molecules Hetero shares 17 molecules Alivus Life Sciences shares 16 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
Company filings
Revenue as reported