Suppliers / Honour Lab

Honour Lab

India Updated 9 July 2026

Honour Lab is an API and finished-dose manufacturer based in India. It holds 79 active US drug master files and 9 valid CEPs. Its filings concentrate with CDSCO (India) and MINSA (CR). Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 15 November 2019 as VAI.

79
active US DMFs
9
valid CEPs
6
registered plants 4 with an FDA FEI number
29
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
4 of 4 confirmed
Inspections
2 of 2 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

  • 15 November 2019 VAI US FDA
  • 21 August 2015 NAI 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
Visakhapatnam, India Not on file
Sangareddy, India 3009996280
Sangareddy, India 3011766778
Anakapalli District, India 3010828439
Nalgonda, India 3021257926

What they file, and where

Molecule Regulators Docs
Pirfenidone EDQM, SFDA (Saudi Arabia), US FDA 6
Brivaracetam SFDA (Saudi Arabia), US FDA 4
Colchicine SFDA (Saudi Arabia), US FDA 4
Fingolimod EDQM, SFDA (Saudi Arabia), US FDA 4
Sitagliptin EDQM, SFDA (Saudi Arabia), US FDA 4
Teriflunomide EDQM, SFDA (Saudi Arabia), US FDA 4
Ticagrelor EDQM, SFDA (Saudi Arabia), US FDA 4
Brexpiprazole SFDA (Saudi Arabia), US FDA 3
Clobazam EDQM, SFDA (Saudi Arabia), US FDA 3
Dapagliflozin SFDA (Saudi Arabia), US FDA 3
Show all 30 molecules on file
Dapagliflozin Propanediol SFDA (Saudi Arabia) 3
Empagliflozin US FDA 3
Ertugliflozin US FDA 3
Fosfomycin US FDA 3
Linagliptin SFDA (Saudi Arabia), US FDA 3
Macitentan SFDA (Saudi Arabia), US FDA 3
Posaconazole SFDA (Saudi Arabia), US FDA 3
Tadalafil EDQM, SFDA (Saudi Arabia), US FDA 3
Apixaban SFDA (Saudi Arabia), US FDA 2
Avanafil SFDA (Saudi Arabia), US FDA 2
Bempedoic Acid SFDA (Saudi Arabia), US FDA 2
Diatrizoate US FDA 2
Edoxaban SFDA (Saudi Arabia), US FDA 2
Sacubitril US FDA 2
Sugammadex SFDA (Saudi Arabia), US FDA 2
Tofacitinib SFDA (Saudi Arabia), US FDA 2
Vildagliptin SFDA (Saudi Arabia), US FDA 2
Alogliptin US FDA 1
Atogepant US FDA 1
Avatrombopag US FDA 1

Also appears on these molecule pages

Alogliptin API Avanafil API Avatrombopag API Azilsartan Medoxomil API Baricitinib finished dose Bempedoic Acid API Bosentan API Brexpiprazole API Brivaracetam API Cabotegravir API Cariprazine finished dose Chlorthalidone API
Show 43 more molecule pages
Clobazam API Cobicistat API Colchicine API Crisaborole API Dapagliflozin Propanediol API Dimethyl contract manufacturing Doxylamine API Edoxaban API Eluxadoline API Ertugliflozin API Fingolimod API Fosfomycin API Isavuconazonium API L-Glutamine API Letermovir API Lifitegrast API Linagliptin API Lithium Carbonate API Macitentan API Molnupiravir API Nebivolol API Ospemifene API Pirfenidone API Posaconazole API Riociguat API Sacubitril API Selexipag API Sitagliptin API Sugammadex API Tadalafil API Tafamidis API Tavaborole API Tedizolid finished dose Teriflunomide API Ticagrelor API Tofacitinib API Upadacitinib finished dose Vibegron API Vildagliptin API Vonoprazan API Empagliflozin API Dapagliflozin API Apixaban API

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 25 None
MINSA (CR) 4 None
EMA None 1

Questions about Honour Lab

Does Honour Lab hold a US DMF or a CEP?
Honour Lab holds 79 active US drug master files and 9 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 Honour Lab FDA-registered?
4 sites operated by Honour Lab 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 Honour Lab's last inspection go?
The most recent inspection on record closed on 15 November 2019 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Honour Lab manufacture?
6 registered sites are on record, in India (Hyderabad, Visakhapatnam and Sangareddy among others). Every site is listed on this page with the register it came from.
What does Honour Lab make?
30 molecules are on record against Honour Lab, including Pirfenidone, Brivaracetam, Colchicine and Fingolimod. Each links through to that molecule's full manufacturer list.
Which regulators recognise Honour Lab's GMP?
Current GMP certificates are on record from 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.

Comparing suppliers?

Choose your molecules and target markets. Honour Lab comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • 4 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 15 November 2019.

Comparable suppliers

Apitoria Pharma shares 18 molecules Alivus Life Sciences shares 17 molecules Dr Reddy's Laboratories shares 15 molecules Alembic Pharmaceuticals shares 15 molecules Biophore India Pharmaceuticals shares 15 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