Suppliers / Galentic Pharma

Galentic Pharma

India 255 employees 3 duplicate records merged Updated 9 July 2026

Galentic Pharma is a finished-dose manufacturer based in India. It appears in 35 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with TMDA (TZ), ZAMRA (ZM) and MCAZ (ZW). Its GMP standing is certified by CDSCO (India) and TMDA (TZ). Its most recent recorded inspection, by US FDA, closed on 8 December 2022 as VAI.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
35
filings across 5 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 8 December 2022 VAI US FDA
  • 21 February 2018 VAI US FDA
  • 24 February 2017 OAI US FDA

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

Registered plants

Site FDA FEI
Gandhidham, India 3012178852
gandhidhambhuj kutch, India Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
TMDA (TZ) 14 1
ZAMRA (ZM) 9 None
MCAZ (ZW) 6 None
NMRC (NA) 5 None
NAFDAC (NG) 1 None
CDSCO (India) None 2

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Open risk flags

  • The most recent inspection outcome was VAI, on 8 December 2022.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates