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

Questions about Galentic Pharma

Does Galentic Pharma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Galentic Pharma. It does have 35 filings with 5 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Galentic Pharma FDA-registered?
One site operated by Galentic Pharma 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 Galentic Pharma's last inspection go?
The most recent inspection on record closed on 8 December 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file, of which 1 closed as OAI.
Where does Galentic Pharma manufacture?
2 registered sites are on record, in India (Gandhidham and Gandhidhambhuj Kutch). Every site is listed on this page with the register it came from.
Which regulators recognise Galentic Pharma's GMP?
Current GMP certificates are on record from CDSCO (India) and TMDA (TZ). 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.

Comparing suppliers?

Choose your molecules and target markets. Galentic Pharma comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

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

Comparable suppliers

Abbott Healthcare also in India Accent Pharmaceuticals Diagnostics also in India Accure Labs Pvt.Ltd also in India ACME Formulation also in India Acme Generics also in India

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