Uganda —The Uganda National Drugs Authority (NDA) has approved Dei Biopharma Ltd’s plans to begin manufacturing medicine in Matugga, Wakiso district.
This information was revealed by the pharma firm’s owner, Dr Mathias Magoola, during a news conference with Ugandan paper New Vision Online.
The company plans to manufacture a variety of vital medications, including vaccinations, biological solutions, and cancer therapies, on a 150-acre complex.
This makes the biotech facility the first in Africa under a US patent, producing the latest cancer treatments, biosimilars, peptides, cell therapy, biologics, cytokines, therapeutic proteins, gene therapy, and vaccines, including mRNA and others..
With this clearance, Dei Biopharma Limited becomes completely compliant with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO) criteria for producing high-quality pharmaceuticals and vaccines.
Furthermore, their injectables will produce critical medications such as filgrastim, erythropoietin, and trastuzumab.
He also stated that the company has a vast warehousing facility equipped with cutting-edge cold chain equipment capable of holding 60,000 pallets of mRNA, other vaccines, and pharmaceutical products.
“This certification marks a major achievement for our company because it allows it to produce essential drugs, hard gelatin capsules, and tablets, among other product categories, in different dosage forms,” Dr. Magoola declared
He went on to say that the cancer drug manufacturing plant, which is designed to satisfy FDA standards under EOL5 guidelines and technology, will also be completed soon.
Additionally, the virus vaccine facility, which is slated to open next year, will manufacture a variety of immunizations, including tetanus toxoid, tetanus diphtheria, hepatitis B, DTP-Hep B-Hib, TIV/QIV, PCV 10, TCV, COVID-19, and HPV bivalent vaccines.
According to him, the NDA issued two certificates to the company, which President Museveni commissioned in October 2022, allowing it to manufacture medications and verifying the suitability of its facilities.
The certificates, granted under the National Drug Policy and Authority Regulations 2014, certify the company’s adherence to the necessary norms and regulations.
Magoola explained that the first certificate, numbered NDA/PRE/PMC/11331, certifies that his premises at Block 82, Plot 988-990 and 3325-3326 Kigogwa, Bombo Road, Uganda, are suitable for drug manufacturing, while the second certificate authorises the company to manufacture finished pharmaceuticals, including non-beta-lactam (human) tablets and hard capsules.
He went on to applaud President Museveni for his support of Ugandan scientists and innovation, which has helped the company accomplish milestones such as the establishment of Africa’s first biotech facility.
Magoola further claimed that the YKTM (Yoweri Kaguta Tibuhaburwa Museveni) GLP Biotech Laboratories are an important part of the facility, which contains components for cancer research, QA/QC, drug discovery, gene therapy, cell therapy, mRNA therapies, 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,” he stated.
The drug company has already received a considerable investment of more than UGX 1.8 trillion (US$500 million) and is estimated to cost US$1.1 billion when completed.
Parliament recently approved a supplementary expenditure budget of UGX 1.106 trillion (US$293.606 million) to settle the offtake agreement between the Ugandan government and Dei Biopharma Limited, as well as pay, pension, and gratuity deficits.
According to the House, the Ugandan government launched the process of purchasing shares in the medicine firm as a strategic intervention to improve local pharmaceutical drug output.
The corporation has also received shillings UGX 578.4 billion (US$153.546 million) to finish commercial production and comfortably cover its debt obligations and operating requirements.
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