Suppliers / Hikal

Hikal

India HIKAL.NS 2 duplicate records merged Updated 9 July 2026

Hikal is an API manufacturer based in India. It holds 32 active US drug master files and 19 valid CEPs. Its filings concentrate with MINSA (CR) and CDSCO (India). Its GMP standing is certified by CDSCO (India), EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 7 February 2025 as OAI. Customs aggregates show $112.7M of exports covering 855 molecules to 55 destinations in 2025.

32
active US DMFs
19
valid CEPs
5
registered plants 2 with an FDA FEI number
7
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
6 of 6 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

  • 7 February 2025 OAI US FDA
  • 12 May 2023 NAI US FDA
  • 2 August 2019 VAI US FDA
  • 18 November 2016 NAI US FDA
  • 13 September 2012 VAI US FDA
  • 5 August 2011 NAI US FDA

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

Registered plants

Site FDA FEI
Bengaluru, India 3003560263
Bangalore, India Not on file
Bharuch, India 3009627283
Bengaluru, India Not on file
bengaluru 560 105, India Not on file

What they file, and where

Molecule Regulators Docs
Sitagliptin EDQM, SFDA (Saudi Arabia), US FDA 5
Bupropion US FDA 4
Gabapentin EDQM, US FDA 3
Ondansetron EDQM, US FDA 3
Pregabalin EDQM, US FDA 3
Celecoxib EDQM, US FDA 2
Lacosamide EDQM, US FDA 2
Memantine SFDA (Saudi Arabia), US FDA 2
Pentoxifylline EDQM, US FDA 2
Quetiapine EDQM, US FDA 2
Show all 30 molecules on file
Rivaroxaban EDQM, US FDA 2
Valaciclovir EDQM, US FDA 2
Venlafaxine EDQM, US FDA 2
Venlafaxine Hydrochloride EDQM 2
Apixaban US FDA 1
Butorphanol US FDA 1
Cariprazine US FDA 1
Cinnarizine EDQM 1
Dabigatran US FDA 1
Dabigatran Etexilate Mesilate EDQM 1
Dapagliflozin US FDA 1
Desvenlafaxine US FDA 1
Edoxaban US FDA 1
Empagliflozin US FDA 1
Ertugliflozin US FDA 1
Flunarizine Dihydrochloride EDQM 1
Gemfibrozil EDQM 1
Quetiapine Fumarate EDQM 1
Triprolidine US FDA 1
Vildagliptin US FDA 1

Also appears on these molecule pages

Apixaban contract manufacturing Canagliflozin contract manufacturing Cariprazine API Celecoxib contract manufacturing Cinnarizine contract manufacturing Dabigatran contract manufacturing Dabigatran Etexilate Mesilate API Dapagliflozin contract manufacturing Desvenlafaxine API Donepezil contract manufacturing Duloxetine contract manufacturing Ertugliflozin API
Show 18 more molecule pages
Flunarizine contract manufacturing Flurbiprofen contract manufacturing Gabapentin contract manufacturing Lacosamide API Memantine contract manufacturing Ondansetron contract manufacturing Pentoxifylline contract manufacturing Pregabalin contract manufacturing Quetiapine contract manufacturing Sitagliptin contract manufacturing Valaciclovir API Valacyclovir API Venlafaxine contract manufacturing Vildagliptin contract manufacturing Empagliflozin API Rivaroxaban API Bupropion API Edoxaban API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 5 None
CDSCO (India) 2 2
EMA None 1
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $17.9M 29
2025 $213.5M $112.7M 55
2024 $213.3M $108.7M 60
2023 $245.0M $115.1M 60

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 Hikal

Does Hikal hold a US DMF or a CEP?
Hikal holds 32 active US drug master files and 19 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 Hikal FDA-registered?
2 sites operated by Hikal 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 Hikal's last inspection go?
The most recent inspection on record closed on 7 February 2025 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 6 inspections are on file, of which 1 closed as OAI.
Where does Hikal manufacture?
5 registered sites are on record, in India (Bengaluru, Bangalore and Bharuch among others). Every site is listed on this page with the register it came from.
What does Hikal make?
30 molecules are on record against Hikal, including Sitagliptin, Bupropion, Gabapentin and Ondansetron. Each links through to that molecule's full manufacturer list.
Which regulators recognise Hikal's GMP?
Current GMP certificates are on record from CDSCO (India), EMA and US FDA. 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

  • One recent serious compliance event is on record.
  • The most recent inspection outcome was OAI, on 7 February 2025.

Comparable suppliers

Apitoria Pharma shares 8 molecules Hetero shares 5 molecules Zydus Lifesciences shares 5 molecules Aurore Life Sciences shares 5 molecules MSN Laboratories shares 4 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