Suppliers / Harman Finochem

Harman Finochem

India Updated 9 July 2026

Harman Finochem is an API and finished-dose manufacturer based in India. It holds 31 active US drug master files and 29 valid CEPs. Its filings concentrate with MINSA (CR), US FDA and BOMRA (BW). Its GMP standing is certified by EMA, US FDA and MFDS (Korea). Its most recent recorded inspection, by US FDA, closed on 12 September 2025 as NAI. Customs aggregates show $63.0M of exports covering 908 molecules to 73 destinations in 2025.

31
active US DMFs
29
valid CEPs
6
registered plants 4 with an FDA FEI number
18
filings across 3 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

  • 12 September 2025 NAI US FDA
  • 22 March 2024 VAI US FDA
  • 23 February 2024 NAI US FDA
  • 15 February 2019 NAI US FDA
  • 27 July 2018 NAI US FDA
  • 20 July 2018 NAI US FDA
  • 8 May 2015 VAI US FDA
  • 27 March 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
Chhatrapati Sambhajinagar, India 3015838038
Mumbai, India Not on file
Chhatrapati Sambhajinagar, India 3003130103
Chhatrapati Sambhajinagar, India 3041504075
Chhatrapati Sambhajinagar, India 3004101736
Aurangabad, India Not on file

What they file, and where

Molecule Regulators Docs
Glycopyrronium EDQM, SFDA (Saudi Arabia), US FDA 6
Oxybutynin EDQM, SFDA (Saudi Arabia), US FDA 5
Lidocaine EDQM, US FDA 4
Methylphenidate EDQM, SFDA (Saudi Arabia) 4
Phenobarbital EDQM, SFDA (Saudi Arabia), US FDA 4
Sitagliptin EDQM, SFDA (Saudi Arabia), US FDA 4
Allopurinol EDQM, SFDA (Saudi Arabia), US FDA 3
Metformin EDQM, SFDA (Saudi Arabia), US FDA 3
Clofazimine EDQM, US FDA 2
Dapagliflozin SFDA (Saudi Arabia), US FDA 2
Show all 30 molecules on file
Fenofibrate EDQM, US FDA 2
Isoprenaline EDQM, US FDA 2
Norepinephrine EDQM, US FDA 2
Phenytoin EDQM, US FDA 2
Valsartan EDQM, US FDA 2
Benzatropine US FDA 1
Bisoprolol EDQM 1
Carisoprodol US FDA 1
Choline Fenofibrate US FDA 1
Efinaconazole US FDA 1
Fenofibric Acid US FDA 1
Fospropofol US FDA 1
Ketamine EDQM 1
Levomethadone EDQM 1
Linagliptin US FDA 1
Meprobamate US FDA 1
Metformin Hydrochloride EDQM 1
Methadone EDQM 1
Methylphenobarbital EDQM 1
Neostigmine US FDA 1

Also appears on these molecule pages

Allopurinol contract manufacturing Alogliptin contract manufacturing Arformoterol contract manufacturing Benzatropine API Bisoprolol contract manufacturing Carisoprodol contract manufacturing Choline Fenofibrate API Cyclobenzaprine contract manufacturing Dapagliflozin API Dexmethylphenidate contract manufacturing Efinaconazole API Epinephrine contract manufacturing
Show 34 more molecule pages
Febuxostat contract manufacturing Fenofibrate contract manufacturing Formoterol contract manufacturing Glycopyrronium API Isoprenaline API Ketamine API Lidocaine contract manufacturing Linagliptin contract manufacturing Lurasidone contract manufacturing Meprobamate contract manufacturing Metformin contract manufacturing Methadone contract manufacturing Methylphenidate contract manufacturing Neostigmine contract manufacturing Norepinephrine contract manufacturing Oxybutynin contract manufacturing Permethrin contract manufacturing Phenobarbital contract manufacturing Phenytoin contract manufacturing Promethazine finished dose Propofol contract manufacturing Sacubitril contract manufacturing Sacubitril/Valsartan API Selenious Acid API Sitagliptin API Sodium Valproate API Succinylcholine contract manufacturing Theophylline finished dose Tolterodine contract manufacturing Torasemide API Valproic Acid API Valsartan contract manufacturing Vilazodone contract manufacturing Vildagliptin API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 10 None
US FDA 6 3
BOMRA (BW) 2 None
EMA None 4
MFDS (Korea) None 2

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $13.8M 46
2025 Not reported $63.0M 73
2024 Not reported $62.3M 69
2023 Not reported $48.5M 71

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

Questions about Harman Finochem

Does Harman Finochem hold a US DMF or a CEP?
Harman Finochem holds 31 active US drug master files and 29 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 Harman Finochem FDA-registered?
4 sites operated by Harman Finochem 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 Harman Finochem's last inspection go?
The most recent inspection on record closed on 12 September 2025 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Harman Finochem manufacture?
6 registered sites are on record, in India (Chhatrapati Sambhajinagar, Mumbai and Aurangabad among others). Every site is listed on this page with the register it came from.
What does Harman Finochem make?
30 molecules are on record against Harman Finochem, including Glycopyrronium, Oxybutynin, Lidocaine and Methylphenidate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Harman Finochem's GMP?
Current GMP certificates are on record from EMA, US FDA and MFDS (Korea). 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

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was NAI, on 12 September 2025.

Comparable suppliers

Apitoria Pharma shares 8 molecules Dr Reddy's Laboratories shares 7 molecules Alembic Pharmaceuticals shares 7 molecules Ipca Laboratories shares 7 molecules Macleods Pharmaceuticals shares 7 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