Suppliers / Pliva Croatia

Pliva Croatia

Croatia Updated 9 July 2026

Pliva Croatia is an API manufacturer based in Croatia. It appears in 8 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with BOMRA (BW), EMA and EDE (AE). Its GMP standing is certified by ANVISA (Brazil), EMA and MHRA (UK).

0
active US DMFs
0
valid CEPs
4
registered plants
8
filings across 5 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Zagreb, United Arab Emirates Not on file
ZAGREB, Croatia Not on file
ZAGREB, Croatia Not on file
Brdovec, Croatia Not on file

What they file, and where

Molecule Regulators Docs
Sugammadex SFDA (Saudi Arabia) 2
Dasatinib SFDA (Saudi Arabia) 1
Imatinib SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Dasatinib API Imatinib API Sugammadex API

Filings and GMP by regulator

Regulator Filings GMP certificates
BOMRA (BW) 3 None
EMA 2 1
EDE (AE) 1 None
NCELS (KZ) 1 None
BRELA (TZ) 1 None
ANVISA (Brazil) None 4
MHRA (UK) None 1

Questions about Pliva Croatia

Does Pliva Croatia hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Pliva Croatia. It does have 8 filings with 5 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Pliva Croatia manufacture?
4 registered sites are on record, in United Arab Emirates and Croatia (Zagreb, Zagreb and Brdovec among others). Every site is listed on this page with the register it came from.
What does Pliva Croatia make?
3 molecules are on record against Pliva Croatia, including Sugammadex, Dasatinib and Imatinib. Each links through to that molecule's full manufacturer list.
Which regulators recognise Pliva Croatia's GMP?
Current GMP certificates are on record from ANVISA (Brazil), EMA and MHRA (UK). 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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Sources on this page

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