CECAEN Rev 3
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Sections Correlation Guide About the Project Contact
Group 211

Manufacture of basic pharmaceutical products

This category covers the manufacture of active substances and intermediates that form the basis of medicines, not the finished products found in pharmacies. It is essentially the heart of the pharmaceutical industry, producing the essential ingredients for treatments.

Included Activities & Applicability

  • ✅ Manufacture of basic medicinal products
  • ✅ including antibiotics
  • ✅ vitamins and hormones Manufacture of active pharmaceutical ingredients (APIs) Manufacture of pharmaceutical intermediates Manufacture of basic chemical pharmaceutical products Production of pharmaceutical plant extracts Manufacture of precursors for medicines

Excluded Activities & Restrictions

  • ❌ Manufacture of finished medicinal products (CAEN subdivision 212)
  • ❌ Wholesale of pharmaceutical products (CAEN 464)
  • ❌ Fundamental research in the pharmaceutical field (CAEN 721)
  • ❌ Manufacture of medical equipment (CAEN 325)
  • ❌ Medical laboratory analysis activities (CAEN 869)

Subordinate Structure

2110 Manufacture of basic pharmaceutical products
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Detailed Analysis & Commercial Insights

Manufacture of basic pharmaceutical products (CAEN Code 211)

The manufacture of basic pharmaceutical products (CAEN Code 211) represents a strategic component of the Romanian economy, with a direct impact on national health security. This division includes the production of active pharmaceutical ingredients (APIs), intermediates and basic ingredients subsequently used in the formulation of finished medicines. In the context of the pandemic and global supply chain crises, Romania has realized the need to relocate and develop its own production capacities for active pharmaceuticals, reducing dependence on imports from Asia.

The Romanian pharmaceutical industry has experienced steady growth, but the segment of basic product manufacturing remains relatively underdeveloped compared to countries such as Hungary or Poland. However, recent investments in industrial parks and production facilities, supported by European funds and the need for regionalization, offer significant opportunities. At the macroeconomic level, the development of this sector contributes to increasing high value-added exports and attracting advanced technological know-how.

The main challenges for entrepreneurs in this field include high compliance costs with Good Manufacturing Practices (GMP) regulations, the need for massive investments in laboratory and production equipment, as well as difficult access to specialized personnel in pharmaceutical chemistry. Also, fluctuations in global demand and competition with producers from India and China represent constant risks. Nevertheless, the trend of reshoring pharmaceutical production and prioritizing health security opens new perspectives for those who choose to operate in this niche.

In the long term, the manufacture of basic pharmaceutical products in Romania can become a pillar of the local economy, provided that authorities facilitate access to financing and simplify the bureaucracy associated with production authorizations. Collaboration with universities and research institutes can generate patented innovations, strengthening the country's position on the European pharmaceutical map.