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Uganda’s National Drug Authority (NDA) has granted a landmark license to Dei Biopharma Limited to manufacture drugs at its premises in Matugga on the outskirts of Kampala City along Bombo road.
The certification marks a major achievement for the company, allowing it to produce essential drugs, including Hard Gelatin Capsules and Tablets, among other product categories in different dosage forms.
The Drug Authority issued two certificates to Dei Biopharma, authorizing the company to manufacture drugs and confirming the suitability of its premises for drug manufacturing.
The certificates, issued under the National Drug Policy and Authority Regulations 2014, validate the company’s compliance with the required standards and regulations.
The first certificate, numbered NDA/PRE/PMC/11331, certifies that Dei Biopharma’s premises at Block 82, Plot 988-990 and 3325-3326 Kigoogwa, Bombo Road, Uganda, are suitable for drug manufacturing. The second certificate authorizes the company to manufacture finished pharmaceutical products, including Non-Beta Lactam (Human) tablets and Hard Gelatin Capsules.
Dr. Matthias Magoola, the founder and Chief Executive Officer of Dei Biopharma, thanked President Museveni for supporting Ugandan scientists and innovation, contributing to the company’s achievements, including the development of the first biotech facility in Africa.
With a 150-acre facility, the company is poised to manufacture a wide range of essential drugs, including vaccines, biological solutions, and cancer treatments. The facility has already received a significant investment of over USD 500 million (UGX 1.8 trillion) and is expected to cost USD 1.1 billion (UGX 4.1 trillion) upon completion.
The facility boasts a biotech facility, the first in Africa under U.S patent, which will produce the latest cancer drugs, biosimilars, peptides, cell therapy, biologics, cytokines, therapeutic proteins, gene therapy, and vaccines, including mRNA and others.
The facility is fully compliant with FDA, EU-EMA, and WHO standards, ensuring the production of high-quality drugs and vaccines.
The company’s injectables facility will manufacture vital drugs, including Filgrastim, Erythropoietin, and Trastuzumab. The facility also features a massive warehousing facility, complete with cutting-edge cold chain technology, capable of storing 60,000 pallets of mRNA and other vaccines, as well as other pharmaceutical products.
The YKTM (Yoweri Kaguta Tibuhaburwa Museveni) GLP Biotech Laboratories, a crucial component of the facility, include components for cancer research, Quality Assurance /Quality Control, drug discovery, gene therapy, cell therapy, mRNA therapeutics, vaccines, biosimilars, and biologics.
The generic section will manufacture over 150 different drugs and medicines, while the state-of-the-art nutraceuticals section will produce tablets, capsules, sachets, ointments, and syrups.
The penicillin, cephalosporin, and non-beta lactam facility will be completed this year and its designed to meet the most stringent US Food and Drug Administration (FDA), World Health Organisation (WHO), and European Medicine Agency guidelines.
The oncology/cancer manufacturing facility, designed to meet FDA standards under EOL5 guidelines and technology, will also be completed soon.
Furthermore, the virus vaccines facility, expected to be completed next year, will produce a range of vaccines, including tetanus toxoid, tetanus diphtheria, hepatitis B among others.