Suppliers / Joint Stock Company “Grindeks”

Joint Stock Company “Grindeks”

Latvia 3 duplicate records merged Updated 9 July 2026

Joint Stock Company “Grindeks” is an API and finished-dose manufacturer based in Latvia. It holds 2 active US drug master files across a filed portfolio of 3 molecules. Its filings concentrate with FAMHP (BE), DAV (Vietnam) and JFDA (JO). Its GMP standing is certified by NCELS (KZ).

2
active US DMFs
0
valid CEPs
1
registered plants
27
filings across 4 regulators

Registered plants

Site FDA FEI
Riga, United Arab Emirates Not on file

What they file, and where

Molecule Regulators Docs
Oxytocin SFDA (Saudi Arabia), US FDA 3
Droperidol SFDA (Saudi Arabia), US FDA 2
Dexmedetomidine SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
FAMHP (BE) 15 None
DAV (Vietnam) 7 None
JFDA (JO) 4 None
COFEPRIS (MX) 1 None
NCELS (KZ) None 1

Questions about Joint Stock Company “Grindeks”

Does Joint Stock Company “Grindeks” hold a US DMF or a CEP?
Joint Stock Company “Grindeks” holds 2 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.
Where does Joint Stock Company “Grindeks” manufacture?
1 registered site is on record, in United Arab Emirates (Riga). Every site is listed on this page with the register it came from.
What does Joint Stock Company “Grindeks” make?
3 molecules are on record against Joint Stock Company “Grindeks”, including Oxytocin, Droperidol and Dexmedetomidine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Joint Stock Company “Grindeks”'s GMP?
Current GMP certificates are on record from NCELS (KZ). 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