TAHA PHARMAPharmaceutical laboratory
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Pharmaceutical laboratory · since 2010

Quality medicines, accessible to all.

Taha Pharma develops and manufactures generic and essential medicines at its Medjez El Bab site, inspected against European Good Manufacturing Practice (GMP).

Explore our products
Catalogue 47 products across 11 therapeutic areas. Quality EU GMP, FDA, GCC, ISO 9001 and ISO/IEC 17025. R&D Formulation, analytical development, bioequivalence and 5 invention patents. Plant 4,000 m² of solid dosage form production in Medjez El Bab.
Analyst in the Taha Pharma quality control laboratory Operator running production equipment
4,000 m²of production space designed to European standards

Who we are

Industrial rigour in the service of patients

“Therapeutic solutions that meet patients’ needs, for a better quality of life.”

Founded in February 2010, Taha Pharma specialises in manufacturing medicines for human use, with a focus on new generics and essential medicines. Its research and development department conducts the bioequivalence studies that ensure products meet strict quality criteria, for the benefit of patients in Tunisia and abroad.

Learn more
47
Products in the catalogue
5
INNORPI patents
3
International authorities

Accreditations & international quality

A manufacturing site recognised by three leading authorities

Each document can be viewed in full. Registration numbers allow direct verification in the official databases where these are public.

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
ISO 9001, ISO/IEC 17025 and quality system

Inside the plant

Virtual tour of the Medjez El Bab plant

Choose a production step: the corporate video jumps straight to the matching point of interest.

Quality control laboratory
Corporate video · 1 min 11 s · 7 points of interest

Our products

A portfolio covering the main therapeutic areas

Full catalogue

Research & development

From molecule to medicine, a controlled process

A formulation development laboratory and an analytical development laboratory, staffed by engineers, pharmacists and technicians, carry each project through to industrial scale-up.

Discover our R&D
  1. 01Active substance selectionChoice of molecule and qualification of active pharmaceutical ingredient (API) suppliers.
  2. 02Pre-formulationPhysicochemical characterisation of the API and excipient compatibility.
  3. 03Formulation & processesFormula development and approval of manufacturing processes.
  4. 04Analytical validationDevelopment and validation of test methods.
  5. 05Stability studiesBatch monitoring under standardised storage conditions.
  6. 06BioequivalenceDemonstration of equivalence with the reference product.
  7. 07Marketing authorisation dossierPreparation and submission of the marketing authorisation dossier.
  8. 08Industrial scale-upScale-up, validation and monitoring of marketed products.

In the press

  • Agence Tunis Afrique Presse
  • Mosaïque FM
  • L’Économiste Maghrébin
  • African Manager
  • Tunisia IT
  • TuniBusiness

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