Vitema Pharmaceuticals has embarked on a transformational journey through its joint venture with DY Nutrition, investing more than €10 million in state-of-the-art technology to expand manufacturing capabilities, the establishment of an R&D centre and an ambitious decision to produce nutritional supplements in compliance with GMP pharmaceutical standards, using sustainable renewable energy solutions to streamline costs and significantly reduce the company’s carbon footprint. All of these decisions put consumer safety at the forefront through products of the highest quality standards, while protecting the environment for a sustainable future.

A new milestone in nutritional supplement production

The joint venture between Vitema Pharmaceuticals, one of the most sustainable and modern GMP-accredited facilities in South East Europe, and DY Nutrition, the nutritional supplements company founded by the famous British bodybuilder Dorian Yates, six-time Mr. Olympia, involved an investment of over 10 million euros and included the transfer of a UK management team to Romania, establishing a new research and development centre in Sibiu.

At the end of 2023, with the change in management team, both the company name and structure changed and the business model migrated from a traditional drug factory to a dynamic company that develops brand concepts for third parties and manufactures at their request. With this new business model, all production workflows have been rethought and modernised. Vitema Pharmaceuticals is a company specialising in contract manufacturing services for pharmaceuticals and nutritional supplements, meeting the quality standards of the pharmaceutical industry. It provides services from idea to shelf positioning and has all the necessary capabilities to handle both small-scale and industrial-scale production of a wide range of products: general pharmaceuticals, nutritional supplements and sports nutrition, oncology drugs, vitamins, minerals, proteins, amino acids, and collagen.

The company’s new structure and the modernisation of its production facilities have enabled it to expand its annual capacity to 3.5 billion capsules and tablets, 4,500 tonnes of powders, and 20 million commercial units, with a mission of reaching 50 million commercial units in the near future.

Safety, Safety, and Safety… Again

The joint venture’s business philosophy is safety-centric. “Safety, Safety, and Safety… Again” is not just a slogan, but a promise that every product that leaves the Vitema Pharmaceuticals facility is rigorously tested and meets the highest quality standards. This approach sets the company apart in the nutritional supplement market, where quality discrepancies are common due to a lack of strict quality control regulations on the production process and the raw and packaging materials used in dietary supplements, applicable to all manufacturers.

Nutritional supplements manufactured to GMP pharmaceutical standards

In the absence of strict regulations, Vitema Pharmaceuticals has proactively set a framework for producing dietary supplements to the same quality and safety standards as medicines, which is the highest standard. This is guaranteed by the pharmaceutical GMP certification the company holds. In addition to the Good Manufacturing Practice (GMP) certificate, they hold ISO 9001:2015 and ISO 22000:2018 certifications. In practice, ensuring these standards is done by rigorously testing raw materials, intermediates, finished products, and packaging materials from a physicochemical and microbiological point of view in their laboratories. These processes ensure that the raw materials to be used in the manufacturing process meet purity standards. For supplements, this testing is not mandatory and not all manufacturers take these demanding control measures, not adhering to the GMP manufacturing standard, as not all factories have this certification, which often leads to a significant discrepancy in the quality of products available on the market.

The differences between GMP Pharma and GMP Food are significant. Pharmaceutical GMP certification is regulated by the National Drug Agency and is subject to the highest level of scrutiny and regulation due to the stringent requirements needed to ensure the safety, efficacy, and consistency of medicines, unlike GMP standards for dietary supplements which are more flexible and rely primarily on compliance with quality standards, but without requiring the same rigorous checks as GMP Pharma.

Vitema has implemented a fully closed production system covering the entire process from receipt of raw materials to final packaging, eliminating any risk of cross-contamination. All products manufactured at Vitema Pharmaceuticals, medicines, and dietary supplements, are subject to strict controls specific to GMP-certified facilities.

The company has implemented an integrated quality-food safety management system, which allows traceability of all processes carried out.

The business operates in a 31,300 m2 functional complex that allows them to carry out in-house all stages of processing, quality control and storage of raw materials and finished products. Raw and packaging materials are purchased from qualified suppliers. Representative samples are taken at each delivery for analysis. Only materials with an analysis report proving physical-chemical and microbiological conformity are used in production. Access to production premises and laboratories is electronically controlled and is only possible for trained personnel working in the area. Production takes place in premises that are continuously monitored for temperature, pressure, and humidity. Microbiological monitoring of surfaces and equipment is also carried out. The premises have been designed to prevent cross-contamination, with each operation taking place in dedicated areas. All stages of production are constantly checked by in-process control. The finished product is sampled and analysed and is accompanied on delivery by an analysis report, which attests to the quality of the product and thus ensures that every product leaving the factory complies exactly with the ingredients declared on the label.

Vitema Pharmaceuticals has decided to produce nutritional supplements following the rigorous standards of the pharmaceutical industry, and this is an important step in the development of the nutritional supplement industry and in prioritising consumer health.

Production powered by renewable energy

A key aspect of this transformational journey is a commitment to sustainability. Through the project funded by Innovation Norway, Vitema Pharmaceuticals has installed photovoltaic panels with a capacity of 0.58 MW, producing approximately 710 MWh annually. This project significantly reduces the company’s carbon footprint and supports environmentally friendly production of medicines and nutritional supplements.