Suppliers / Kalintis Healthcare

Kalintis Healthcare

India 78 employees Updated 9 July 2026

Kalintis Healthcare is an API manufacturer based in India. It holds 16 active US drug master files across a filed portfolio of 11 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 17 October 2025 as NAI. Customs aggregates show $3.4M of exports covering 65 molecules to 15 destinations in 2025.

16
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 17 October 2025 NAI US FDA
  • 14 December 2018 NAI US FDA

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

Registered plants

Site FDA FEI
Vadodara, India 3013455974

What they file, and where

Molecule Regulators Docs
Diphenoxylate US FDA 4
Torasemide US FDA 2
Trimethobenzamide US FDA 2
Benzatropine US FDA 1
Cevimeline US FDA 1
Furosemide US FDA 1
Lorazepam US FDA 1
Methenamine US FDA 1
Methimazole US FDA 1
Mexiletine US FDA 1
Show all 11 molecules on file
Oxazepam US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $242K 2
2025 Not reported $3.4M 15
2024 Not reported $3.8M 8
2023 Not reported $2.3M 4

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 We do not publish the identity of any buyer.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 NAI, on 17 October 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