Suppliers / Swati Spentose

Swati Spentose

India Updated 9 July 2026

Swati Spentose is an API manufacturer based in India. It holds 23 active US drug master files and 7 valid CEPs across a filed portfolio of 14 molecules. Its GMP standing is certified by CDSCO (India), US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 31 May 2024 as VAI. Customs aggregates show $20.3M of exports covering 630 molecules to 68 destinations in 2025.

23
active US DMFs
7
valid CEPs
10
registered plants 1 with an FDA FEI number
5
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 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

  • 31 May 2024 VAI US FDA
  • 12 December 2018 VAI US FDA
  • 12 January 2018 VAI US FDA
  • 26 February 2016 VAI US FDA

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

Registered plants

Site FDA FEI
Mumbai, India Not on file
Vapi, India Not on file
vapi valsad 396 195, India Not on file
vapi 396 195 valsad, India Not on file
Vapi, India Not on file
Vapi, India 3009765202

4 further sites are on record.

What they file, and where

Molecule Regulators Docs
Lidocaine EDQM, SFDA (Saudi Arabia), US FDA 9
Prilocaine EDQM, SFDA (Saudi Arabia), US FDA 7
Granisetron SFDA (Saudi Arabia), US FDA 3
Melatonin EDQM, US FDA 3
Meloxicam SFDA (Saudi Arabia), US FDA 3
Tamsulosin EDQM, US FDA 3
Glycopyrronium US FDA 2
Pentosan Polysulfate Sodium US FDA 2
Silodosin US FDA 2
Dutasteride EDQM 1
Show all 14 molecules on file
Fluocinolone Acetonide SFDA (Saudi Arabia) 1
Lidocaine Hci SFDA (Saudi Arabia) 1
Mirabegron US FDA 1
Triamcinolone Acetonide EDQM 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 5 9
US FDA None 1
EMA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $2.9M 40
2025 Not reported $20.3M 68
2024 Not reported $13.8M 68
2023 Not reported $12.1M 59

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 We do not publish the identity of any buyer.

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Open risk flags

  • The most recent inspection outcome was VAI, on 31 May 2024.

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