Suppliers / Synergene Active Ingredients

Synergene Active Ingredients

India Updated 9 July 2026

Synergene Active Ingredients is an API manufacturer based in India. It holds 6 active US drug master files across a filed portfolio of 6 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 17 February 2024 as VAI. Customs aggregates show $5.7M of exports covering 250 molecules to 44 destinations in 2025.

6
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 February 2024 VAI US FDA
  • 8 September 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
Anakapalli, India 3010634351

What they file, and where

Molecule Regulators Docs
Escitalopram US FDA 1
Fluconazole US FDA 1
Irbesartan US FDA 1
Losartan US FDA 1
Terbinafine US FDA 1
Voriconazole 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 $843K 18
2025 Not reported $5.7M 44
2024 Not reported $6.2M 39
2023 Not reported $8.6M 39

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 We do not publish the identity of any buyer.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 17 February 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