Suppliers / Gelita

Gelita

Germany Updated 9 July 2026

Gelita is an API manufacturer based in Germany. It holds 11 valid CEPs. Its filings concentrate with EEC_EAEU and EDA (EG). Its GMP standing is certified by ZLG (DE). Its most recent recorded inspection, by US FDA, closed on 18 January 2023 as VAI.

0
active US DMFs
11
valid CEPs
2
registered plants 1 with an FDA FEI number
11
filings across 2 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

  • 18 January 2023 VAI US FDA
  • 11 September 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
Eberbach, Germany Not on file
Germany, Germany 1000510106

What they file, and where

Molecule Regulators Docs
Gelatin EDQM 11

Also appears on these molecule pages

Gelatin API

Filings and GMP by regulator

Regulator Filings GMP certificates
EEC_EAEU 8 None
EDA (EG) 3 None
ZLG (DE) None 4

Questions about Gelita

Does Gelita hold a US DMF or a CEP?
Gelita holds 11 valid CEPs. 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 Gelita FDA-registered?
One site operated by Gelita 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 Gelita's last inspection go?
The most recent inspection on record closed on 18 January 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Gelita manufacture?
2 registered sites are on record, in Germany (Eberbach and Germany). Every site is listed on this page with the register it came from.
What does Gelita make?
1 molecule is on record against Gelita, including Gelatin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Gelita's GMP?
Current GMP certificates are on record from ZLG (DE). 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 18 January 2023.

Comparable suppliers

PB Gelatins shares 1 molecule Baotou Dongbao Bio-Tech shares 1 molecule Sichuan Raybo Biotechnology shares 1 molecule Tessenderlo Group shares 1 molecule Weihai Yinhe Biological Technology shares 1 molecule

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