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.
突尼斯仿制药和非处方药制造商，为国内和非洲法语国家医疗保健买家提供服务。
Opalia Pharma 是一家突尼斯药品制造商，专门生产人用仿制药和非处方药，由 Alya El Hedda 和 Marco Montanari 于 1988 年创立。该公司出口到阿尔及利亚、摩洛哥和几个非洲法语市场。
- 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
- 医疗保健用品
- Markets
- 突尼斯, 阿尔及利亚, 摩洛哥, 喀麦隆
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.