The National Drug Authority (NDA) has granted Dei Biopharma Limited a landmark license to manufacture drugs at its Matugga premises. This 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 various dosage forms.
The NDA issued two certificates to Dei Biopharma Limited, authorizing the company to manufacture drugs and confirming the suitability of its premises for drug production. These certificates, issued under the National Drug Policy and Authority Regulations 2014, validate the company’s compliance with required standards and regulations.
- The first certificate (NDA/PRE/PMC/11331) certifies that Dei Biopharma Limited’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 Group of Companies, expressed gratitude to President Yoweri Museveni for his support of Ugandan scientists and innovation, which has contributed to the company’s success, including the development of Africa’s first biotech facility.
Expanding Dei Biopharma’s Role in Drug Manufacturing
With its 150-acre facility, Dei Biopharma Limited is positioned to produce a diverse range of essential drugs, including vaccines, biological solutions, and cancer treatments. The company has already invested over USD 500 million in the facility, with an expected total completion cost of USD 1.1 billion.
The facility includes:
- Africa’s first biotech facility under US patent, which will manufacture:
- The latest cancer drugs
- Biosimilars
- Peptides
- Cell therapy
- Biologics
- Cytokines
- Therapeutic proteins
- Gene therapy
- mRNA and other vaccines
The facility is fully compliant with FDA, EU-EMA, and WHO standards, ensuring the production of high-quality drugs and vaccines.
Additionally, the injectable facility, which is 80% complete, will manufacture vital drugs, including:
- Filgrastim
- Erythropoietin
- Trastuzumab
The site also features a massive warehousing facility, equipped with cutting-edge cold chain technology, capable of storing 60,000 pallets of mRNA vaccines and other pharmaceutical products.
YKTM GLP Biotech Laboratories & Future Developments
The YKTM (Yoweri Kaguta Tibuhaburwa Museveni) GLP Biotech Laboratories are a crucial part of the facility, supporting:
- Cancer research
- Quality Assurance/Quality Control (QA/QC)
- Drug discovery
- Gene therapy
- Cell therapy
- mRNA therapeutics
- Vaccines
- Biosimilars
- Biologics
The generics section will manufacture over 150 different drugs, while the nutraceuticals section will produce:
- Tablets
- Capsules
- Sachets
- Ointments
- Syrups
Upcoming Manufacturing Expansions
- Next year, the penicillin, cephalosporin, and non-beta-lactam facility will be completed, adhering to the most stringent FDA, WHO, and EU-EMA guidelines.
- The oncology/cancer drug manufacturing facility will also be finalized under FDA standards and EOL5 technology.
- The virus vaccine facility, expected to be completed next year, will manufacture a variety of vaccines, including:
- Tetanus toxoid
- Tetanus diphtheria
- Hepatitis B
- DTP-Hep B-Hib
- TIV/QIV (Influenza Vaccines)
- PCV 10 (Pneumococcal Vaccine)
- TCV (Typhoid Conjugate Vaccine)
- COVID-19 vaccine
- HPV bivalent vaccine
