Division 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.

Included Activities & Applicability

  • 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 & Restrictions

  • 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)

Detailed Analysis & Commercial Insights

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.