Etodolac

About us Polpharma Group Polpharma API API Manufacturing sites
 

We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs), that is proceeding with a $45-million manufacturing expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from 2024 with full completion scheduled for Q3 2024.

CDMO Competencies & Services Quality Environmental protection Customer experience
 

Polpharma API CDMO (Contract Development and Manufacturing Organization) supports emerging and large pharmaceutical customers in the development and commercialization of their small-molecule APIs clinical candidates thanks to +70 years of experience in process development, scale-up, and cGMP manufacturing of small molecule APIs in volumes ranging from kilos to tens of tons.

Generics Core competencies Products
 

We manufacture our products by following our customers' and health authorities' most stringent requirements. DMF documentation for all our products is prepared in accordance with the latest requirements of EDQM (CEP), ICH (EuDMF, CTD), and FDA (US DMF). Material and product testing is performed in line with the European and United States Pharmacopeias.

Technologies Cryogenic High Potent Capabilities
 

We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs) that is proceeding with a $35-million facility expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from Q1 2024, with full completion scheduled for Q3 2024.

Our products

Etodolac

CAS No.

41340-25-4

Reference product

N/A

Polymorphic form

Crystalline racemate, none

Therapeutic Area

Musculo-skeletal system

Status

commercial

EU DMF readiness

✓

US DMF readiness

011405

CEP

✓

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.

Disclaimer
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).