Montenegro is considering the domestic production of selected medicines through state-owned pharmaceutical distributor Montefarm, with Turkish companies invited to explore potential cooperation and investment.
The government said on Sept. 2 that pharmaceutical production was discussed during talks with senior representatives of Türkiye’s health ministry and international healthcare organisation USHAŞ. Foreign Minister Ervin Ibrahimović told the Turkish delegation that Montefarm planned to begin producing certain types of medicines and invited Turkish companies to consider cooperation and investment. No investment value, product list, partner or production timetable has been announced.
Montefarm prepares for pharmaceutical production
The initiative would expand Montefarm’s existing role as a state institution responsible for procuring and distributing medicines and medical supplies to Montenegro’s public healthcare system. Montefarm operates 55 pharmacies across the country and has maintained a dedicated Galenic Laboratory Sector since 2021.
The sector has been preparing documentation, quality standards and regulatory requirements for establishing the production of galenic medicines. That work provides a potential starting point for limited domestic pharmaceutical production rather than developing a conventional drug-manufacturing industry from the beginning. Galenic production involves preparing medicines in larger batches within authorised pharmacy or healthcare structures using established formulations. For Montenegro’s market, such production could allow selected medicines to be supplied locally without immediately competing with large generic-drug manufacturers in Europe or Asia.
Small domestic market limits production scale
Montenegro has a population of slightly more than 600,000, limiting domestic demand for most individual medicines. Pharmaceutical manufacturing requires substantial fixed investment in production lines, laboratories, quality systems and regulatory personnel, making high utilisation important to production economics. A facility serving only Montenegro would therefore need to focus on products for which supply security, short production runs or public-health requirements support local production. Large-volume generic medicines manufactured internationally at scale would be more difficult to produce competitively unless a Montenegrin facility could also serve export markets.
Manufacturing would require regulatory investment
Montenegro’s medicines framework regulates industrial production and requires systems designed to ensure quality, safety and efficacy. The national medicines agency CInMED maintains registers of manufacturers and updated its procedures in 2026 for manufacturing authorisations and Good Manufacturing Practice (GMP) certification.
Moving beyond limited galenic production would therefore require more than manufacturing equipment. Facilities would need controlled premises, qualified personnel, validated processes, analytical laboratories, documented quality systems, batch-release procedures and systems for investigating deviations and product complaints. Raw-material suppliers would also need to be controlled, while sterile products would require additional technical and investment measures because of contamination-control requirements.
Turkish cooperation remains under consideration
Türkiye could provide a potential source of pharmaceutical manufacturing expertise because of its larger pharmaceutical production base. A Turkish partner could potentially provide equipment, production know-how, validated formulations or staff training, while Montefarm could contribute local market knowledge and access to Montenegro’s public healthcare supply chain. Discussions remain preliminary, and the government has not announced any commitment by a Turkish company to invest.
The main rationale for domestic production would be supply security, rather than import substitution alone. Small pharmaceutical markets can face shortages when international manufacturers prioritise larger markets or determine that maintaining registrations for low-volume products is commercially unattractive. Domestic production would not remove dependence on imports because active pharmaceutical ingredients and other inputs would still need to be sourced externally. It could, however, provide Montenegro with greater control over selected medicines that are repeatedly difficult to procure or are unattractive for international suppliers to manufacture in small quantities.
Montefarm could provide public-sector demand
Montefarm already supplies pharmacies, health centres, hospitals, the Clinical Centre, the Institute of Public Health and other public institutions. That existing public-sector supply chain could provide predictable demand for selected products and help justify production lines that would otherwise depend entirely on retail sales.
The structure would also require clear separation between Montefarm’s procurement and manufacturing functions. Public procurement would still need to maintain competition and establish that domestically produced medicines provide appropriate quality and value.
Production could support wider pharmaceutical services
A domestic manufacturing base would require specialised personnel including production pharmacists, analytical chemists, microbiologists, quality-assurance specialists, validation engineers and regulatory experts. Independent laboratories could undertake testing of raw materials and finished medicines, while engineering companies could supply controlled environments, ventilation, purified-water systems and monitoring equipment.
Software providers could also support batch documentation, inventory management and quality-control systems. These capabilities would be relevant whether Montenegro ultimately manufactures dozens of medicines or maintains a smaller strategic portfolio. A functioning production and testing capacity could also support healthcare resilience during shortages, emergency procurement or disruptions to regional supply chains. The COVID-19 period increased awareness among small European countries of their dependence on distant manufacturing centres. For Montenegro, the proposed approach centres on selective production rather than attempting to manufacture medicines across the full pharmaceutical spectrum.
The existing Galenic Laboratory could serve as a starting point. If Montefarm establishes compliant production, demonstrates stable quality and achieves costs that compare favourably with imported medicines, additional categories could potentially follow. The latest discussions with Turkish representatives do not establish a Montenegrin pharmaceutical industry or confirm an investment. They mark an examination of whether Montefarm, traditionally focused on purchasing and distributing medicines manufactured elsewhere, could also take on a limited domestic manufacturing role.
