The National Drug Authority (NDA) has granted two licences to Dei Biopharma Limited, allowing them start manufacturing drugs.
Mr Abiaz Rwamwiri, the NDA spokesperson, said the first certificate issued by NDA authorizes Dei to manufacture different drugs while the second certificate endorses the suitability of the premises
The plant which sits on 150 acres in Matugga, Wakiso District, will produce all forms of essential medicine, including; vaccines, and other biological solutions listed as essential drugs including Filgrastim, Erythropoietin, and Trastuzumab.
“NDA issues a license for every product which one is intending to produce and that firm has been issued with the license to produce certain products,” Mr Rwamwiri said.
Mr Mathias Magoola, the founder of Dei Biopharma, welcomed the licences.
He said the plant will now be in a position to start manufacturing essential drugs.
The plant’s generic section which has the capacity to produce 150 different types of drugs will start with 25 types including; capsules and tablets.
The entire facility comprises nine sections. They include the bio-tech Facility, Injectable, Warehousing, YKTM GLP Biotech Laboratories, Generic Section, Nutraceuticals Section, Penicillin, Cephalosporin and Non-Beta Lactam Facility, Oncology/Cancer Manufacturing Facility, the Virus Vaccines Facility, where majority are under construction.
This comes two weeks after Parliament passed a supplementary budget that saw Shs578b earmarked for Mr Magoola’s plant.
It’s expected that upon completion, the plant will manufacture over 150,000 essential drugs, vaccines, biological solutions, and cancer treatments.
According to Mr Magoola, the facility has already received a significant investment of over $500m (Shs1.8t) and is expected to cost $1.1b (Shs4.1t) upon completion.
The facility boasts a biotech facility, the first in Africa under a US patent, which will produce the latest cancer drugs, biosimilar, peptides, cell therapy, biologics, cytokines, therapeutic proteins, gene therapy, and vaccines, including mRNA and others.
He added that the facility is fully compliant with the Food and Drug Administration (FDA), European Union-European Medicines Agency (EU-EMA), and World Health Organisation (WHO) standards, ensuring the production of high-quality drugs and vaccines.
“The company’s injectable facility 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,” he added.
Some of the critical sections in the plant are YTKM-GLP Biotech Laboratories, a crucial component of the facility, including components for cancer research, QA/QC, drug discovery, gene therapy, cell therapy, mRNA therapeutics, vaccines, biosimilar, and biologics.
Others are penicillin, cephalosporin, and non-beta lactam facility, designed to meet the most stringent FDA, WHO, and EU-EMA guidelines, which will be completed next year.
