Suppliers / Softgel Healthcare

Softgel Healthcare

India 485 employees 3 duplicate records merged Updated 9 July 2026

Softgel Healthcare is a finished-dose manufacturer based in India. It appears in 70 regulatory filings across 12 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), MINSA (CR) and FDA (GH). Its GMP standing is certified by US FDA, ANVISA (Brazil) and EMA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 14 February 2025 as VAI. Customs aggregates show $20.8M of exports covering 616 molecules to 37 destinations in 2025.

0
active US DMFs
0
valid CEPs
7
registered plants 2 with an FDA FEI number
70
filings across 12 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 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

  • 14 February 2025 VAI US FDA
  • 22 February 2019 VAI US FDA
  • 29 April 2016 VAI US FDA
  • 29 June 2012 VAI US FDA

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

Registered plants

Site FDA FEI
Kancheepuram District, United Arab Emirates Not on file
Chengalpattu, India 3041045488
KANCHEEPURAM DISTRICT, India Not on file
Chengalpattu, India 3006381009
KANCHEEPURAM, India Not on file
Kancheepuram, India Not on file

1 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 30 None
MINSA (CR) 10 None
FDA (GH) 6 None
DIGEMAPS (DO) 5 None
NAFDAC (NG) 4 1
EEC_EAEU 3 None
US FDA None 1
ANVISA (Brazil) None 1
EMA None 1
MHRA (UK) None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $1.4M 10
2025 Not reported $20.8M 37
2024 Not reported $10.9M 37
2023 Not reported $10.3M 34

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 We do not publish the identity of any buyer.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 14 February 2025.

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