NDA clears Dei Biopharma to manufacture key vaccines
KAMPALA, May 14, 2024 – Dei Biopharma Limited based in Matugga, Wakiso district, has received National Drug Authority [NDA] accreditation, marking a significant milestone in the company’s commitment to delivering high-quality vaccines and contributing to the advancement of public health in Uganda and beyond.
According to the officials, this certification marks a major achievement for the company, enabling it to produce essential drugs, including Hard Gelatin Capsules and tablets, among other product categories in different dosage forms.
The NDA issued two certificates to Dei Biopharma Limited, authorising the company to manufacture vaccines 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 Limited’s premises at Block 82, Plot 988-990 & 3325-3326 Kigoogwa, Bombo Road, Uganda, are suitable for drug manufacturing.
The second certificate authorises the company to manufacture finished pharmaceutical products, including Non-Beta Lactam [human] tablets and Hard Gelatin Capsules.
The facility boasts a biotech facility, the first in Africa under US 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 injectable facility, 80 percent complete, 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, QA/QC, 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, designed to meet the most stringent FDA, WHO, and EU-EMA guidelines, will be completed next year. The oncology/cancer manufacturing facility, designed to meet FDA standards under EOL5 guidelines and technology, will also be completed soon.
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