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.
Entrepreneur Profile
This CAEN code 212 is intended for entrepreneurs and companies (SRL, PFA) wishing to develop a business focused on manufacture of pharmaceutical preparations. It is ideal for founders aiming to offer specialized services or products in this economic niche within the Romanian market.
Who should avoid:
Avoid the exclusive use of code 212 if the main activity of your company shifts towards other commercial or related branches not specified in the official description. See the excluded activities section below.
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.
Included Activities
- ✅ 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
- ❌ 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)
Similar or Related CAEN Codes:
From the same category of economic activities:
Întrebări Frecvente
What type of companies can use CAEN code 212?
Any legal entity in Romania (SRL, PFA, Individual Enterprise) performing activities related to "manufacture of pharmaceutical preparations" is required to have this code authorized in its articles of incorporation or at the Trade Register.
Are special permits required for CAEN 212?
The need for permits depends on the exact nature of the operations carried out under class 212. Some activities require authorizations from DSV, Environment, or Occupational Safety, while others can be conducted solely based on the self-declaration at incorporation.