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.
Nhà sản xuất thuốc generic và OTC của Tunisia phục vụ người mua dịch vụ chăm sóc sức khỏe trong nước và Pháp ngữ ở Châu Phi.
Opalia Pharma là nhà sản xuất dược phẩm Tunisia chuyên về thuốc generic và các sản phẩm không kê đơn dành cho con người, được thành lập vào năm 1988 bởi Alya El Hedda và Marco Montanari. Công ty xuất khẩu sang Algeria, Maroc và một số thị trường châu Phi nói tiếng Pháp.
- 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
- Vật tư y tế và chăm sóc sức khỏe
- Markets
- Tunisia, Algeria, Ma-rốc, Cameroon
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.