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

Fluconazole API Terbinafine API Voriconazole API Losartan API Escitalopram API Irbesartan API

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 We do not publish the identity of any buyer.

Questions about Synergene Active Ingredients

Does Synergene Active Ingredients hold a US DMF or a CEP?
Synergene Active Ingredients holds 6 active US drug master files. 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 Synergene Active Ingredients FDA-registered?
One site operated by Synergene Active Ingredients 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 Synergene Active Ingredients's last inspection go?
The most recent inspection on record closed on 17 February 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Synergene Active Ingredients manufacture?
1 registered site is on record, in India (Anakapalli). Every site is listed on this page with the register it came from.
What does Synergene Active Ingredients make?
6 molecules are on record against Synergene Active Ingredients, including Escitalopram, Fluconazole, Irbesartan and Losartan. Each links through to that molecule's full manufacturer list.
Which regulators recognise Synergene Active Ingredients's GMP?
Current GMP certificates are on record from US FDA. 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 17 February 2024.

Comparable suppliers

Apitoria Pharma shares 3 molecules Dr Reddy's Laboratories shares 3 molecules Alivus Life Sciences shares 3 molecules MSN Laboratories shares 2 molecules Hetero shares 2 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