Opalia Pharma
Company-provided description, not an official-source fact. Certifications, capacities, years and market positions stated in it are the company's own claims until a record below confirms them.
国内およびアフリカのフランス語圏のヘルスケアバイヤーにサービスを提供するチュニジアのジェネリック医薬品およびOTCメーカー。
オパリア ファーマは、1988 年にアリヤ エル ヘッダとマルコ モンタナーリによって設立された、人間向けのジェネリック医薬品と市販薬を専門とするチュニジアの医薬品メーカーです。同社はアルジェリア、モロッコ、およびいくつかのフランス語圏のアフリカ市場に輸出しています。
- Type
- Not established by any record (our catalog import lists it as manufacturer; that is not evidence of the role)
- Role
- Role not established by any record
- Location
- Tunis, Tunisia
- Founded
- 1988 (from our catalogue record; not confirmed by the company or by a state register)
- Website
- https://www.opaliapharma.com.tn
- Categories
- 医療およびヘルスケア用品
- Markets
- チュニジア, アルジェリア, モロッコ, カメルーン
What is established and what is not
No researcher review has been written for this company yet. 1 official record from 1 official source is on file. 2 other entries are not official records: our own technical checks and searches, open directory listings, our inferences or the company's own statements. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. Nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
Facts on file, each with its evidence type
- No match found in the debarment registers we checked (record type: debarment-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public debarment datasets and found no matching candidate. Absence from these lists is a search result, not a certificate. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-12. OpenSanctions
- No match found on the sanctions lists we checked (record type: sanctions-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public sanctions datasets and found no matching candidate. A name search is not full compliance screening. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-12. OpenSanctions
- Listed in the national industrial register as an industrial site (record type: industrial-site-registered; this record does not by itself establish manufacturing) [official record; status green] The country's industrial register lists this company as holding a working industrial establishment, with its own registry number and activity code. A trading office does not get one. Open the source for the entry. checked 2026-09-24. APII (Agence de Promotion de l'Industrie et de l'Innovation, Tunisia), directory of operational industrial enterprises
Claimed certifications, not confirmed by us
- Good Manufacturing Practice
- ISO 9001, Quality Management IAF CertSearch
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)
Check independently
Before a first order, ask for the legal entity's registration number and country, then check it in the official register.