Suppliers / Swati Spentose

Swati Spentose

India Updated 9 July 2026

Swati Spentose is an API and finished-dose 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
Vapi, India Not on file
vapi valsad 396 195, India Not on file
Mumbai, India Not on file
Vapi, India Not on file
vapi 396 195 valsad, 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

Dienogest finished dose Dutasteride API Fluocinolone Acetonide API Glycopyrronium API Granisetron API Lidocaine API Meloxicam API Pentosan Polysulfate API Prilocaine API Silodosin API Tamsulosin API Triamcinolone Acetonide API
Show 2 more molecule pages
Ulipristal finished dose Mirabegron API

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.

Questions about Swati Spentose

Does Swati Spentose hold a US DMF or a CEP?
Swati Spentose holds 23 active US drug master files and 7 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 Swati Spentose FDA-registered?
One site operated by Swati Spentose 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 Swati Spentose's last inspection go?
The most recent inspection on record closed on 31 May 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Swati Spentose manufacture?
10 registered sites are on record, in India (Vapi, Vapi Valsad 396 195 and Mumbai among others). Every site is listed on this page with the register it came from.
What does Swati Spentose make?
14 molecules are on record against Swati Spentose, including Lidocaine, Prilocaine, Granisetron and Melatonin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Swati Spentose's GMP?
Current GMP certificates are on record from CDSCO (India), US FDA and EMA. 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 VAI, on 31 May 2024.

Comparable suppliers

Apitoria Pharma shares 4 molecules Cipla shares 4 molecules Dr Reddy's Laboratories shares 3 molecules Zydus Lifesciences shares 3 molecules Apex Healthcare shares 3 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