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Dei Biopharma breaks ground, gets approval to make drugs

The NDA has issued two crucial certificates to Dei Biopharma Limited, granting authorization for drug manufacturing

The NDA has issued two crucial certificates to Dei Biopharma Limited, granting authorization for drug manufacturing

Dei Biopharma Limited has received a groundbreaking license from the National Drug Authority (NDA) to start manufacturing drugs at its Matugga facility in the central district of Wakiso.

This regulatory approval signifies a significant milestone for the company, enabling it to produce a wide range of vital medications, including hard gelatin capsules and tablets, across various dosage forms.

The NDA has issued two crucial certificates to Dei Biopharma Limited, granting authorization for drug manufacturing and affirming the suitability of its premises for this purpose. These certificates, issued in accordance with the National Drug Policy and Authority Regulations of 2014, serve as official recognition of the company’s adherence to stipulated standards and regulatory requirements.

The initial certificate, identified as NDA/PRE/PMC/11331, officially confirms that Dei Biopharma Limited’s premises located at Block 82, Plot 988-990 & 3325-3326 Kigoogwa, Bombo road, Uganda, meet the necessary standards for drug manufacturing.

Meanwhile, the second certificate grants the company explicit authorization to produce finished pharmaceutical products, encompassing non-beta lactam (human) tablets and hard gelatin Capsules.

Dr Matthias Magoola, the founder and chief executive officer of Dei Biopharma, expressed gratitude to President Museveni for his steadfast support of Ugandan scientists and innovation, which has significantly contributed to the company’s achievements. Notably, this support has played a pivotal role in establishing the first biotech facility in Africa under Dei Biopharma’s banner.

With a sprawling 150-acre facility at its disposal, Dei Biopharma Limited is strategically positioned to manufacture a diverse array of indispensable medications, spanning vaccines, biological solutions, and cancer treatments. The facility has already garnered substantial investment exceeding $500 million and is anticipated to reach a total project cost of $1.1 billion upon its culmination.

The facility proudly houses the first biotech establishment in Africa operating under a US patent, poised to lead in the production of cutting-edge cancer drugs, biosimilars, peptides, cell therapy solutions, biologics, cytokines, therapeutic proteins, gene therapy treatments, and vaccines, including mRNA formulations.

Compliant with stringent standards set by the FDA, EU-EMA, and WHO, this facility guarantees the production of pharmaceuticals and vaccines of the highest quality.

Among its notable features, the company’s injectables facility will be dedicated to the manufacture of essential medications such as filgrastim, erythropoietin, and trastuzumab. Additionally, the facility boasts an expansive warehousing unit equipped with state-of-the-art cold chain technology capable of accommodating up to 60,000 pallets of mRNA vaccines and other pharmaceutical products.

Integral to the facility is the YKTM (Yoweri Kaguta Tibuhaburwa Museveni) GLP Biotech Laboratories, encompassing critical components for cancer research, quality assurance and control (QA/QC), drug discovery, gene therapy, cell therapy, mRNA therapeutics, vaccine development, biosimilar production, and biologics manufacturing.

Furthermore, the generic section will oversee the production of more than 150 different drugs and medicines, while the advanced nutraceuticals division will manufacture a variety of formulations, including tablets, capsules, sachets, ointments, and syrups, employing state-of-the-art technology and processes.

The forthcoming penicillin, cephalosporin, and non-beta lactam facility, meticulously designed to adhere to the most rigorous standards set by the FDA, WHO, and EU-EMA, is scheduled for completion within the upcoming year.

Simultaneously, the oncology/cancer manufacturing facility, engineered to comply with FDA regulations under EOL5 guidelines and employing cutting-edge technology, is nearing its final stages of development.

Additionally, the virus vaccines facility, slated for completion next year, is poised to manufacture a diverse array of vaccines, encompassing 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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