21
Manufacture of basic pharmaceutical products
This division covers the production of medicines and active pharmaceutical substances. If you manufacture pills, syrups, vaccines or basic substances for medicines, this is your code. The process involves transforming raw materials into finished products, including industry-specific packaging.
Entrepreneur Profile
This CAEN code 21 is intended for entrepreneurs and companies (SRL, PFA) wishing to develop a business focused on manufacture of basic pharmaceutical products. 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 21 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.
Pharmaceutical Industry in Romania: A Strategic Sector for Economic Development
The pharmaceutical industry in Romania has experienced significant growth in recent decades, transforming from a predominantly import-oriented sector into an important regional producer. NACE Division 21, covering the manufacture of basic pharmaceutical products, lies at the intersection of scientific innovation, public health policy and national economic strategy. In the macroeconomic context, this industry contributes substantially to the trade balance, the creation of highly skilled jobs and the country's medicinal security. Romania has a tradition in the production of active substances, and recent investments in modern factories have strengthened the country's position on the European pharmaceutical map.
Entrepreneurs operating in this field face specific challenges such as high compliance costs with GMP standards, fluctuations in raw material prices, and fierce competition from generic manufacturers in Asia. However, increased domestic demand, an aging population, and the expansion of health insurance systems offer consistent opportunities. Additionally, digitalization of the supply chain and automation of manufacturing processes are becoming critical success factors. In recent years, there has been a trend to relocate the production of essential medicines to Europe, which may favor Romanian producers meeting international standards.
To succeed in this niche, a deep understanding of national and European regulations, as well as rigorous quality and supply chain management, is essential. Companies that invest in research and development, in partnerships with universities and hospitals, have a better chance of developing innovative products and expanding their market share. In the long term, the Romanian pharmaceutical industry has the potential to become a regional hub, attracting foreign investment and creating significant added value for the economy.
Included Activities
- ✅ Manufacture of medicaments and basic pharmaceutical substances
- ✅ Manufacture of finished pharmaceutical products
- ✅ Manufacture of homeopathic medicines
- ✅ Manufacture of vaccines and biological products
- ✅ Manufacture of antibiotics and other active substances
- ✅ Packaging of pharmaceutical products (including blistering, labelling)
- ✅ Manufacture of food supplements and parapharmaceutical products
Excluded Activities
- ❌ Retail sale of pharmaceutical products (including pharmacies)
- ❌ Pharmaceutical research and development (NACE code 7211)
- ❌ Storage and distribution of pharmaceutical products (NACE code 4631)
- ❌ Manufacture of medical instruments and sanitary materials (NACE code 3250)
- ❌ Medical testing and analysis activities (NACE code 8690)
Similar or Related CAEN Codes:
From the same category of economic activities:
Întrebări Frecvente
What type of companies can use CAEN code 21?
Any legal entity in Romania (SRL, PFA, Individual Enterprise) performing activities related to "manufacture of basic pharmaceutical products" is required to have this code authorized in its articles of incorporation or at the Trade Register.
Are special permits required for CAEN 21?
The need for permits depends on the exact nature of the operations carried out under class 21. Some activities require authorizations from DSV, Environment, or Occupational Safety, while others can be conducted solely based on the self-declaration at incorporation.