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Dei Biopharma gets NDA clearance for drug manufacturing

The National Drug Authority (NDA) has granted Dei Biopharma Limited a landmark license 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 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, thanked President Museveni for supporting Ugandan scientists and innovation, contributing to the company’s achievements, including the development of Africa’s first biotech facility.

Dei Biopharma Limited, with its 150-acre facility, is well-positioned to produce a diverse array of essential drugs such as vaccines, biological solutions, and cancer treatments. Dei Biopharma Limited has already invested over USD 500 million in the facility, with an expected completion cost of USD 1.1 billion.

The facility boasts a biotech facility, the first in Africa under US patent, that 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 has a massive warehousing facility, complete with cutting-edge cold chain technology, capable of storing 60,000 pallets of mRNA, vaccines, and 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 generics 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.

We will complete the penicillin, cephalosporin, and non-beta lactam facility next year, adhering to the most stringent FDA, WHO, and EU-EMA guidelines. We will also soon complete the oncology/cancer manufacturing facility, which adheres to FDA standards under EOL5 guidelines and technology. Furthermore, we expect to complete the virus vaccine facility next year, which will produce a range of vaccines such as 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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Dei Group International