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Magoola’s Dei Biopharma receives NDA clearance for drugs manufacturing

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Mathius Magoola’s Dei Biopharma Limited Company 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

Dei Biopharma Limited has been granted a landmark license by the National Drug Authority (NDA) to manufacture drugs at its premises in Matugga. 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 different 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 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 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, 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, Dei Biopharma Limited 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 and is expected to cost USD 1.1 billion upon completion.

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% 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.

Furthermore, the virus vaccines facility, expected to be completed next year, will produce a range of vaccines, including tetanus toxoid, tetanus diphtheria, hepatitis B, DTP-Hep B-Hib, TIV/QIV, PCV 10, TCV, COVID-19, and HPV bivalent vaccines.

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