Manufacturing
Controlled-atmosphere areas, containment isolators and a partner site that is GMP-certified and FDA and GCC registered.
Industrial partnership
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
A production unit equipped with controlled-atmosphere areas and containment isolators for the safe handling of active substances.
Certified partner 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.
Facilities
Real photos of the Lino Pharma unit: containment isolators, controlled-atmosphere areas and building. Click a photo to enlarge it.
Controlled-atmosphere areas, flow control and transfer airlocks.
Glove-box isolators for handling sensitive active substances.
Physico-chemical and microbiological testing of materials and products.
Control instrumentation — differential pressure and parameters — at every step.
Regulatory compliance
View each official document: regulatory scope, references, dates, preview and PDF download.
Certificate holder: Taha Pharma — Medjez El Bab (Tunisia), our partner manufacturing site.
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).
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.
Gulf Health Council
The Executive Board of the Gulf Health Ministers approved the registration of the manufacturing site (Central Registration Committee, meeting no. 85).
Dates are those shown on the documents. Their authenticity can be checked with the issuing authorities; renewed versions are available on request.
