Manufacturing & Quality
Experience
Our manufacturing plant has been operating for more than 50 years, with constant upgrades to its facilities, mechanical and laboratory equipment and processes to meet modern requirements. From 1948 until today, we have been providing quality products to the patient, offering treatments for various ailments.
Manufacturing Site
"NI-THE" has a privately owned manufacturing site of 3000 sq.m. with capabilities for the production of prescription medicines (Rx), Over-The-Counter medicines (OTC), disinfectants/biocides, food supplements and cosmetics.
Know-How
We have the necessary know-how to produce a wide range of solid, semi-solid and liquid pharmaceutical forms. Our production facilities have modern and specialized mechanical equipment that covers a wide range of production of pharmaceutical forms. Our specialized staff ensures the quality of the products produced in our factory, at every stage from their primary to their final form.
Quality Control
Our company has a modern and well-equipped Quality Control laboratory, in which all the necessary analytical tests, at every stage of the production process, are carried out. From raw materials to the final product, all required procedures and protocols are strictly followed, in accordance with the guidance of Good Laboratory Practice (cGLPs). Our laboratory consists of equipment that covers a wide range of pharmaceutical analysis. Our goal is continuous improvement through modern analytical methods, state-of-the-art equipment, research and development.
Modern manufacturing facilities infrastructure
- Production and Packaging clean areas of high pharmaceutical standards
- Specialized production machinery & equipment
- Modern pharmaceutical analysis laboratories
- Storage areas with controlled temperature & humidity conditions
- Digital Building Management System (BMS) of our manufacturing plant
In our factory we produce:
- Medicines (for human use)
- Biocides – Disinfectants
- Cosmetics
- Food Supplements – Dietary products
Production of Solid Forms
- Tablets: uncoated, coated, effervescent
- Capsules
- Powders – granules
Production of Semi-Solid Forms
- Suppositories
- Ointments: simple, antibiotics
- Creams
- Gels
- Shampoos
- Soaps
Production of Liquid Forms
- Liquids for Internal Use: Syrups – Oral Solutions/Suspensions
- Liquid Solutions for External Use
Packaging Options:
- Vials – Bottles of various sizes with tablets, capsules, powders or granules, liquid or oily solutions
- Tablet blister packs
- Sachets with powders or granules
- Tubes of ointments or creams
- Tubes of ointments or creams
- Mono-dose or uni-dose of liquid or oily solutions
- Single or multiple dose patented oral gum brush with ointment or toothpaste
Storage & Distribution
At NI-THE we ensure full compliance with c-GDP requirements, in order to ensure the correct flow and full traceability of our products and the continuous supply of quality medicines to the market. The storage conditions of our raw materials and finished products are strictly controlled, in accordance with the respective guidelines. Our nationwide coverage network ensures the constant access of every patient to our company’s pharmaceutical products. Our service for incoming orders is immediate, aiming to quickly cover the needs that arise in pharmacies, clinics and hospitals.
Quality Policy
Our company, having a clear orientation towards quality, maintains a Quality Management System (QMS), which follows the quality standards ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ISO17025:2017, ISO 22716:2007 and is harmonized with the legislation and directives of organizations such as the World Health Organization (WHO), the International Council for the Harmonization of Technical Requirements for Medicines for Human Use (ICH), the European Medicines Agency (EMA) as well as the Good Manufacturing Practices (GMP) ) as they are defined by the European Commission (EC) and the National Medicines Organization (EOF).
Certified & controlled production processes – The “NI-THE” manufacturing site is regularly inspected by the competent bodies and is EU GMP Certified by the National Medicines Organization (EOF), for Production, Packaging, Quality Control and Storage of medicines for human use, in accordance with European standards.
Quality of raw materials – We work with the largest companies in the field for the supply of our raw materials, with strict material quality criteria, certified materials of pharmaceutical specifications and properly followed quality standards.
Batch Release – Each batch of final product produced at NI-THE is certified before being placed on the market, ensuring that all manufacturing and control stages have been carried out in accordance with Good Manufacturing Practices (GMP), the Product Marketing Authorization and the respective relevant legislations.
Environment
At NI-THE we take care of our environmental footprint and thus have carefully studied all our processes. In the Environmental Management System we implement, which is based on the ISO 14001:2015 standard, we have taken care of the following actions:
Recycling of the materials we manage
Proper management, minimization of waste and disposal to certified waste management companies
Streamlined power use