nir-vana innovation network

The company was established in 2002 in Tirana.
It is a pharmaceutical manufacturer of generics and brand medical products, operating in accordance with full EU cGMP guide- lines. Current 'Good Manufacturing Practice' of the European Union and other quality standards have been applied and implemented during design, construction and commissioning of this manufacturing site.
Company has started its production on the following pharmaceutical forms: solid pharmaceutical form, liquid pharmaceutical form, and granules for oral suspension.
Its pharmaceutical portfolio includes:
1.Antibiotics;
2.Analgesics;
3.Antacids;
4.Anti-psychotics and neurology;
5.Cough and cold remedies;
6.Vitamins, etc.
Each premises intended for production, processing, or storage of a pharmaceutical product is suitable in space, construction and positioning in order to facilitate cleaning, maintenance and to avoid the possibility of material mixing and cross contamination.
Operations are performed in areas specifically designed and with proper size.
There is also a system for monitoring parameters of the work environment as temperature and humidity, this data is stored in BMS (Building Management System).
Raw material, in process material and personel entry routes are separated and do not cross with each other.
Air cleanliness, volumes, temperature, humidity and pressures are continuously monitored and recorded in all clean room areas as per GMP requirements.
Heating is performed using gas and cooling using water through chillers. All enforced measures exclude the possibility of air cross contamination. At the same time air is re-circulated and cleaned before it is ejected from the system in order to prevent environmental pollution.
Electrical systems are designed and installed in accordance to existing laws and regulations.
Quality control laboratory is separate area adequate for the intention, constructed based on GLP (good laboratory practice) standard. GLP principles have been developed in order to promote quality and validity of the data of analyzes, used to access quality and safety of pharmaceutical products.
Because of expansion, the company is looking for potential partners in the pharmaceutical industry. The potential candidates should have network in their countries. The partner will distribute the company’s products under the distribution services agreement.

Advantages & innovations

-Production, documentation, control, and quality in all relevant processes are continuously improved and updated. -Company accomplishes the goals by employing and training personel to be keen and responsible within their individual functions and by strengthening the knowledge of operating according to best practice. - Their facility and systems are regularly inspected by national and international health authorities. -Validation and qualification of processes, equipment, methods of analyses etc. in all departments is of paramount importance for the ability to provide products of a constant quality, purity, safety, and efficacy with minimum batch variation.

Stage of development

Already on the market

Partner sought

About the distribution services agreement, the potential partner must have experience and client’s portfolio in medical and health sector such as pharmacies, hospitals, care homes, etc. Task to be performed for distribution services: the partner should market the products as best possible and to optimize the purchasing process on a continuous basis.