Suppliers / Somerset Therapeutics

Somerset Therapeutics

India 376 employees Updated 9 July 2026

Somerset Therapeutics is a finished-dose manufacturer based in India. It appears in 84 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its most recent recorded inspection, by US FDA, closed on 21 February 2025 as OAI. Customs aggregates show $194K of exports covering 2 molecules to 2 destinations in 2025.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
84
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 21 February 2025 OAI US FDA
  • 27 October 2023 VAI US FDA
  • 4 April 2022 OAI US FDA
  • 19 February 2020 OAI US FDA
  • 23 July 2019 VAI US FDA
  • 5 December 2017 VAI US FDA
  • 24 April 2017 NAI US FDA
  • 20 August 2013 VAI 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 3003821988

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 84 None

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $1.5M 2
2025 Not reported $194K 2
2024 Not reported $82K 2
2022 Not reported $45K 2

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 We do not publish the identity of any buyer.

Questions about Somerset Therapeutics

Does Somerset Therapeutics hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Somerset Therapeutics. It does have 84 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Somerset Therapeutics FDA-registered?
One site operated by Somerset Therapeutics carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Somerset Therapeutics's last inspection go?
The most recent inspection on record closed on 21 February 2025 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 8 inspections are on file, of which 3 closed as OAI.
Where does Somerset Therapeutics manufacture?
1 registered site is on record, in India (Bengaluru). Every site is listed on this page with the register it came from.
Where does Somerset Therapeutics file?
Filings are on record with US FDA, 84 in total.

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 OAI, on 21 February 2025.

Comparable suppliers

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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
Customs aggregates
Export values, molecule and destination counts