Suppliers / Cohance Lifesciences

Cohance Lifesciences

India COHANCE.NS Updated 9 July 2026

Cohance Lifesciences is an API and finished-dose manufacturer based in India. It holds 108 active US drug master files and 33 valid CEPs. Its GMP standing is certified by EMA, US FDA and MFDS (Korea), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 11 September 2025 as NAI. Customs aggregates show $147.8M of exports covering 1,352 molecules to 71 destinations in 2025.

108
active US DMFs
33
valid CEPs
11
registered plants 6 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
6 of 6 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

  • 11 September 2025 NAI US FDA
  • 7 March 2025 VAI US FDA
  • 12 July 2024 VAI US FDA
  • 23 February 2024 NAI US FDA
  • 14 April 2023 NAI US FDA
  • 1 November 2019 VAI US FDA
  • 20 August 2019 VAI US FDA
  • 1 March 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
Medchal-Malkajgiri, India 3008768274
Hyderabad, India Not on file
MALKAJGIRI, India Not on file
Mumbai, India Not on file
Ntr, India 3005554260
Jaggaiahpet, India Not on file

5 further sites are on record.

What they file, and where

Molecule Regulators Docs
Lamotrigine EDQM, US FDA 6
Tamsulosin EDQM, US FDA 6
Entacapone EDQM, SFDA (Saudi Arabia), US FDA 5
Midazolam EDQM, SFDA (Saudi Arabia), US FDA 5
Atomoxetine EDQM, US FDA 4
Fluvoxamine EDQM, SFDA (Saudi Arabia), US FDA 4
Rivaroxaban EDQM, SFDA (Saudi Arabia), US FDA 4
Zonisamide US FDA 4
Aripiprazole EDQM, US FDA 3
Baclofen EDQM, US FDA 3
Show all 30 molecules on file
Buspirone EDQM, US FDA 3
Dapsone EDQM, US FDA 3
Dipyridamole EDQM, US FDA 3
Irinotecan EDQM, US FDA 3
Itraconazole EDQM, US FDA 3
Pirfenidone EDQM, US FDA 3
Quetiapine EDQM, US FDA 3
Venlafaxine EDQM, US FDA 3
Verapamil EDQM, US FDA 3
Apixaban US FDA 2
Betahistine Dihydrochloride EDQM, SFDA (Saudi Arabia) 2
Chloroquine US FDA 2
Cilostazol US FDA 2
Clozapine US FDA 2
Dapagliflozin US FDA 2
Desvenlafaxine US FDA 2
Diflunisal US FDA 2
Doxazosin US FDA 2
Empagliflozin US FDA 2
Eslicarbazepine Acetate US FDA 2

Also appears on these molecule pages

Apixaban API Aripiprazole API Articaine API Atomoxetine API Baclofen API Benserazide API Betahistine API Buspirone API Cilostazol API Clozapine API Dapagliflozin API Dapsone API
Show 40 more molecule pages
Desvenlafaxine API Dipyridamole API Doxazosin API Doxazosin Mesilate API Entacapone API Eslicarbazepine API Exatecan API Favipiravir finished dose Flurbiprofen API Fluvoxamine API Glycopyrronium API Hydralazine API Hydroxyzine API Irinotecan API Itraconazole API Lamotrigine API Levocetirizine API Levodropropizine API Lurasidone API Meclizine API Memantine API Metaxalone API Methylphenidate API Mexiletine API Midazolam API Mirabegron API Nitazoxanide API Oxymetazoline API Pirfenidone API Posaconazole API Pyridostigmine API Quetiapine API Rivaroxaban API Tamsulosin API Tetraferric Tricitrate Decahydrate API Triethylenetetramine API Venlafaxine API Verapamil API Zonisamide API Empagliflozin API

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 1 None
EMA None 7
US FDA None 4
MFDS (Korea) None 2
ANVISA (Brazil) None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $21.9M 47
2025 $140.0M $147.8M 71
2024 $126.0M $102.3M 65
2023 $163.0M $66.3M 58

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

Questions about Cohance Lifesciences

Does Cohance Lifesciences hold a US DMF or a CEP?
Cohance Lifesciences holds 108 active US drug master files and 33 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 Cohance Lifesciences FDA-registered?
6 sites operated by Cohance Lifesciences 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 Cohance Lifesciences's last inspection go?
The most recent inspection on record closed on 11 September 2025 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Cohance Lifesciences manufacture?
11 registered sites are on record, in India (Medchal-malkajgiri, Hyderabad and Malkajgiri among others). Every site is listed on this page with the register it came from.
What does Cohance Lifesciences make?
30 molecules are on record against Cohance Lifesciences, including Lamotrigine, Tamsulosin, Entacapone and Midazolam. Each links through to that molecule's full manufacturer list.
Which regulators recognise Cohance Lifesciences's GMP?
Current GMP certificates are on record from EMA, US FDA, MFDS (Korea) and ANVISA (Brazil). 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. Cohance Lifesciences comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • 1 active litigation matter is on record.
  • One recent serious compliance event is on record.
  • The most recent inspection outcome was NAI, on 11 September 2025.

Comparable suppliers

Macleods Pharmaceuticals shares 17 molecules Dr Reddy's Laboratories shares 15 molecules Alivus Life Sciences shares 15 molecules Hetero shares 14 molecules Apitoria Pharma shares 13 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