Suppliers / Encube Ethicals

Encube Ethicals

India 461 employees Updated 9 July 2026

Encube Ethicals is a finished-dose manufacturer based in India. It appears in 58 regulatory filings across 9 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA, EDE (AE) and CDSCO (India). Its GMP standing is certified by EMA, US FDA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 23 January 2025 as NAI. Customs aggregates show $102.1M of exports covering 1,786 molecules to 30 destinations in 2025.

0
active US DMFs
0
valid CEPs
4
registered plants 2 with an FDA FEI number
58
filings across 9 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
5 of 5 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

  • 23 January 2025 NAI US FDA
  • 17 June 2024 VAI US FDA
  • 11 June 2019 VAI US FDA
  • 27 August 2015 NAI US FDA
  • 23 March 2012 NAI US FDA

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

Registered plants

Site FDA FEI
Ponda, United Arab Emirates Not on file
PONDÁ, India Not on file
Ponda, India 3005669319
Durham, United States 3015216825

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 36 2
EDE (AE) 13 None
CDSCO (India) 2 None
UZPHARM (UZ) 2 None
INVIMA (CO) 1 None
EEC_EAEU 1 None
EMA None 2
ANVISA (Brazil) None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $16.4M 22
2025 Not reported $102.1M 30
2024 Not reported $70.1M 24
2023 Not reported $60.0M 30

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 We do not publish the identity of any buyer.

Questions about Encube Ethicals

Does Encube Ethicals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Encube Ethicals. It does have 58 filings with 9 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Encube Ethicals FDA-registered?
2 sites operated by Encube Ethicals 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 Encube Ethicals's last inspection go?
The most recent inspection on record closed on 23 January 2025 as NAI (No Action Indicated: nothing objectionable was found). 5 inspections are on file.
Where does Encube Ethicals manufacture?
4 registered sites are on record, in United Arab Emirates, India and United States (Ponda, Pondá and Durham among others). Every site is listed on this page with the register it came from.
Which regulators recognise Encube Ethicals's GMP?
Current GMP certificates are on record from EMA, US FDA 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.

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Open risk flags

  • The most recent inspection outcome was NAI, on 23 January 2025.

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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