Quality & compliance

Quality, demonstrated by independent authorities

Our Medjez El Bab site has been inspected and registered by health authorities in Europe, the United States and the Gulf. Below you will find each official document, its scope and its references.

FDA United States

FDA establishment registration

U.S. Food and Drug Administration

The Taha Pharma site is registered with the U.S. FDA as a drug manufacturing establishment, in accordance with Title 21 of the Code of Federal Regulations, Part 207 (21 CFR Part 207).

Scope & references

Drug Establishment Registration
U.S. fiscal year FY2019
U.S. agent: Registrar Corp, Hampton (Virginia)

FEI: 3014669714
DUNS: 36-265-0563
Labeler Code: 72509
Issued on: 14/11/2018
Expiry: 31/12/2019

Registration of an establishment with the FDA does not constitute FDA approval of its products.

PDF Verifiable · FDA DECRS database

GMP · UE European Union · Portugal

GMP certificate of compliance

INFARMED, I.P. — National Authority of Medicines and Health Products (Portugal)

Following an inspection carried out under Article 111(5) of Directive 2001/83/EC, the Portuguese authority confirms that the Medjez El Bab site complies with EU Good Manufacturing Practice (Directive 2003/94/EC).

Scope & references

Non-sterile solid dosage forms: tablets and hard capsules
Primary and secondary packaging
Quality control testing: microbiological (non-sterile) and chemical/physical

Certificate no.: FT069/MH/001/2018
Inspection: 09/02/2018
EudraGMDP ref.: 50022
Issued on: 11/09/2018

The authenticity of the certificate can be verified in the EudraGMDP database.

PDF Verifiable · EudraGMDP database (EMA)

GCC Gulf States

Manufacturing site registration

Gulf Health Council — Gulf Central Committee for Drug Registration

The Executive Board of the Health Ministers’ Council for the GCC States approved the registration of the Taha Pharma manufacturing site (Central Registration Committee meeting no. 85).

Scope & references

Human medicinal products
Non-sterile production lines: hard capsules and tablets
Validity: five years from the date of issue

Registration no.: GRC/583/18
Registration date: 04/02/2018
Date of issue: 18/02/2018
Issued on: 18/02/2018
Expiry: 18/02/2023

PDF Signed official document

Management system

ISO 9001 certification & ISO/IEC 17025 accreditation

ISO 9001 Management system

ISO 9001:2015 certification

TÜV Rheinland Cert GmbH (DAkkS accreditation)

Scope & references

Head office (Ariana) and production site (Béja)

Registration no.: 01 100 1615613
Issued on: 28/07/2016
Expiry: 27/07/2019

PDF Signed official document

ISO/CEI 17025 Testing laboratory

ISO/IEC 17025 accreditation

TUNAC — Tunisian National Accreditation Council (ILAC-MRA signatory)

Scope & references

Microbiology laboratory — Medjez El Bab site

Accreditation no.: 1-0065
Issued on: 12/01/2016
Expiry: 11/01/2021

PDF Signed official document

Our commitment

A quality system aligned with international standards

Taha Pharma Laboratories aim to rank among the leaders of the Tunisian pharmaceutical industry, with a Quality Management System that complies with current international standards.

This approach covers all activities: development, manufacturing, testing and batch release. It relies on strict hygiene standards and all the quality control procedures needed for patient safety.

Good Manufacturing PracticeEU standard (Directive 2003/94/EC), in line with WHO recommendations.
Quality controlMicrobiological (non-sterile) and physicochemical testing of raw materials, in-process products and finished products.
TraceabilityRecording of manufacturing parameters and tracking of every batch.
BioequivalenceStudies demonstrating equivalence with the reference products.

INFARMED / EudraGMDP verification

GMP certificate no. FT069/MH/001/2018 is listed in the EudraGMDP database (ref. 50022).

Search EudraGMDP

FDA verification

The establishment is identified by FEI 3014669714 and DUNS 36-265-0563. Registration does not constitute approval of the products.

FDA DECRS database

Certified copies

For a registration dossier, a tender or a supplier audit, our teams provide certified copies and the current versions.

Request documents