CECAEN Rev 3
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Sections Correlation Guide About the Project Contact
Group 212

Manufacture of pharmaceutical preparations

This category covers the manufacture of finished pharmaceutical products, including human and veterinary medicines. Essentially, it involves the actual production of medicines, from active substances to the final dosage form, but does not include retail sales to the public or fundamental research.

Included Activities & Applicability

  • ✅ Manufacture of chemical and biological medicinal products Manufacture of homeopathic medicinal products Manufacture of vaccines Manufacture of suppositories
  • ✅ ointments
  • ✅ syrups
  • ✅ drops Manufacture of active pharmaceutical substances (active pharmaceutical ingredients) Manufacture of oral contraceptives Manufacture of veterinary medicinal products

Excluded Activities & Restrictions

  • ❌ Manufacture of herbal medicinal products (classified under 2110)
  • ❌ Manufacture of chemical substances used in the pharmaceutical industry (classified under 2013)
  • ❌ Retail sale of pharmaceutical products (classified under 4773)
  • ❌ Pharmaceutical research and development (classified under 7211)

Subordinate Structure

2120 Manufacture of pharmaceutical preparations
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Detailed Analysis & Commercial Insights

Manufacture of Pharmaceutical Preparations in Romania

The pharmaceutical industry in Romania, represented at the macroeconomic level by NACE division 212, plays a strategic role in ensuring public health and national health security. The manufacture of pharmaceutical preparations covers a wide spectrum of activities, from the synthesis of active substances to the formulation and packaging of finished medicines. In recent years, the sector has experienced accelerated dynamics, driven by increasing domestic demand and the trend towards relocating production to Eastern Europe. Romania benefits from a long tradition in the field, with historic factories such as those in Sibiu or Iași, as well as recent investments from international pharmaceutical giants. This evolution is supported by a legislative framework aligned with EU standards, facilitating exports and attracting funds for modernization. The major challenges for entrepreneurs in this niche include high compliance costs with Good Manufacturing Practices (GMP), fluctuations in raw material prices, and dependence on imports for some active substances. Also, fierce competition from Asian manufacturers, especially China and India, exerts constant pressure on profit margins. However, recent health crises have highlighted the strategic importance of domestic production capacity, stimulating investments in new production lines and applied research. For the future, digitalisation of production processes and adoption of Industry 4.0 technologies, such as artificial intelligence for formulation optimisation, represent real opportunities for differentiation. Moreover, the growing demand for biological and personalised medicines opens new markets but requires advanced skills and significant investments. In conclusion, NACE division 212 remains a pillar of the Romanian economy, with sustained development potential, but requires a strategic approach adapted to global trends and local specifics.