Our products




Reference product


Polymorphic form

Crystalline racemate, none

Therapeutic Area

Musculo-skeletal system



EU DMF readiness

US DMF readiness



Other documentation

Japanese DMF
Korean DMF
Canadian DMF
Brazilian DMF

Drug description:

Etodolac belongs to anti-inflammatory drugs (NSAIDs).
Etodolac is indicated for acute or long term use in: osteoarthritis, rheumatoid arthritis. Etodolac is used to treat pain or inflammation caused by arthritis.
It is formulated as hard capsules, tablets in sustained release formulation, film-coated tablets for oral route of administration.

Mechanism of action:
Etodolac is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic actions. Etodolac is an inhibitor of the cyclooxygenase enzyme (COX) involved in prostaglandin synthesis. Etodolac is an selective inhibitor of COX-2.

Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the product in the imported market(s).
Polpharma’s strategic investment in HPAPI facility
We have launched an investment in a specialized facility
for the R&D and Production of highly active substances
with an OEL value of 10 ng/m3 (OEB 6).

The HP API investment includes separate process
laboratories (PDL), analytical laboratories (ADL)
with the possibility of performing Quality Control
analyses, and a GMP kilo-lab production line with
volume up to 1.5 kg with potential volume increase.