Research & Development
A department dedicated to developing new generics.
Pharmaceutical laboratory · Tunis
Pharmaceutical excellence, in the service of patients.
Lino Pharma manufactures medicines for human use — new generics and essential medicines — in a plant designed to European standards and FDA guidelines.
- 4specialties
- 9presentations
- 3partner-site accreditations
Medicine manufacturing
Medicines for human use: new generics and essential medicines.
Research team
A dynamic team, committed and accountable to patients.
Dynamic organisation
An organisation that fosters employee motivation.
Plant designed to European standards and FDA guidelines
About us
Therapeutic solutions for a better quality of life
Lino Pharma is a pharmaceutical laboratory specialising in the manufacture of medicines for human use, with a focus on new generics and essential medicines.
The laboratory aims to obtain new operating patents, working in a plant designed to European standards and the guidelines of the U.S. Food and Drug Administration (FDA).
Our vision
Therapeutic solutions that meet patients’ needs, for a better quality of life.
Our mission
To provide patients with suitable products that meet quality standards.
Industrial partnership
Manufacturing in synergy
The Lino Pharma unit works with a certified partner manufacturing site: two complementary facilities for development, manufacturing and quality control, serving patients and partners.
Lino Pharma unit
Lino Pharma
A production unit equipped with controlled-atmosphere areas and containment isolators for the safe handling of active substances.
- Glove-box isolators with pressure monitoring
- Controlled-atmosphere areas and transfer airlocks
- Specialties in oncology and women’s health
Certified partner site
Partner manufacturing site
The partner manufacturing site in Medjez El Bab (4,000 m²) is GMP-certified by INFARMED and registered with the U.S. FDA and the Gulf Health Council.
- Solid dosage forms: tablets and capsules
- Physico-chemical and microbiological quality control
- Primary and secondary packaging
Clean rooms
Controlled-atmosphere areas, flow control and transfer airlocks.
Containment
Glove-box isolators for handling sensitive active substances.
Quality control
Physico-chemical and microbiological testing of materials and products.
Process monitoring
Control instrumentation — differential pressure and parameters — at every step.
Regulatory compliance
Three international accreditations
View each official document: regulatory scope, references, dates, preview and PDF download.
Certificate holder: Taha Pharma — Medjez El Bab (Tunisia), our partner manufacturing site.
FDA
Official document
FDA establishment registration
U.S. Food and Drug Administration
The manufacturing site is registered with the U.S. FDA as a drug manufacturing establishment (21 CFR Part 207).
- Issue date
- 14/11/2018
- Stated validity
- 31/12/2019
Scope & references
- Drug Establishment Registration
- U.S. fiscal year FY2019
- U.S. agent: Registrar Corp (Virginia)
- FEI number
- 3014669714
- DUNS number
- 36-265-0563
- Certificate holder
- Taha Pharma — Medjez El Bab, Tunisia
GMP · UE
Official document
GMP compliance certificate
INFARMED, I.P. — National Authority of Medicines (Portugal)
Following an inspection under Article 111(5) of Directive 2001/83/EC, the Portuguese authority certifies that the site complies with EU Good Manufacturing Practice.
- Issue date
- 11/09/2018
- Stated validity
- Not stated on the certificate
Scope & references
- Non-sterile solid forms: tablets and capsules
- Primary and secondary packaging
- Quality control: microbiology and physico-chemistry
- Certificate number
- FT069/MH/001/2018
- Inspection date
- 09/02/2018
- Certificate holder
- Taha Pharma — Medjez El Bab, Tunisia
GCC
Official document
Manufacturing site registration
Gulf Health Council
The Executive Board of the Gulf Health Ministers approved the registration of the manufacturing site (Central Registration Committee, meeting no. 85).
- Issue date
- 18/02/2018
- Stated validity
- 18/02/2023
Scope & references
- Medicines for human use
- Non-sterile lines: capsules and tablets
- Validity: five years from issue
- Registration number
- GRC/583/18
- Registration date
- 04/02/2018
- Certificate holder
- Taha Pharma — Medjez El Bab, Tunisia
Dates are those shown on the documents. Their authenticity can be checked with the issuing authorities; renewed versions are available on request.
Catalogue
Targeted specialties
Research & Development
Rigorous science for patients
Lino Pharma places vital importance on the research and development of new generics.
“At the heart of our mission: rigorous science combined with a great passion for creating and developing generics that meet our patients’ needs and improve their quality of life.”Discover our R&D
Formulation development
A laboratory equipped with sophisticated machines.
Analytical development
A state-of-the-art laboratory.
New generics
Various dosage forms and therapeutic areas.
Industrial scale-up
Scale-up and follow-up of marketed products.
Public health
A public health commitment
Lino Pharma is fully committed to national and regional public health policies.
Lino Pharma listens to health institutions regarding any innovative treatment for rare diseases.