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NDA gives Dei Biopharma nod to start drug manufacturing
What you need to know:
- The entire Dei facility comprises nine sections. They include biotech, injectable, warehousing, generic section, nutraceuticals, penicillin, cephalosporin and non-beta lactam facility, oncology and virus vaccines.
- The company’s injectable facility will manufacture vital drugs, including Filgrastim, Erythropoietin, and Trastuzumab.
The National Drug Authority (NDA) has given a green light to Dei Biopharma to start manufacturing drugs.
The plant, which sits on 150 acres at Matugga, Wakiso District, will produce all forms of essential medicine, including vaccines, and other biological solutions listed as essential drugs; Filgrastim, Erythropoietin, and Trastuzumab.
“NDA issues a licence for every product, which one is intending to produce and that firm [Dei] has been issued with the licence to produce certain products,” Mr Abiaz Rwamwiri, the NDA spokesperson, said last evening.
The first certificate issued by NDA authorises the company to manufacture medicine, including Non-Beta Lactam tablets and Hard Gelatin capsules, and the second certificate endorses the suitability of the premises.
The plant’s generic section, which can produce 150 different types of drugs, will start with 25 types, including capsules and tablets.
Speaking to this publication yesterday, the proprietor of the firm, Mr Mathias Magoola, described the issuance of the certificates by NDA as a “major achievement”.
With these, he said, the plant will now be in a position to start manufacturing essential drugs.
On April 30, Parliament passed a Shs1.1 trillion supplementary budget that saw Shs578b earmarked for Mr Magoola’s plant.
Although the money to Dei BioPharma was approved by Parliament’s Budget Committee, Kiira Municipality legislator Ibrahim Ssemujju Nganda presented a minority report that left the House divided.
Core to his minority report was that Dei is troubled by a $100 million it borrowed from Equity Bank, and all the money the government is extending to the plant would be used to clear the loan. We could not independently verify this claim.
According to Mr Magoola, the facility has already received an investment of about $500m (Shs1.8 trillion) and is expected to cost $1.1b (Shs4.1 trillion) upon completion.
The firm boasts a biotech facility, one of the first in Africa under a 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. Mr Magoola 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.
The entire Dei facility comprises nine sections. They include biotech, injectable, warehousing, generic section, nutraceuticals, penicillin, cephalosporin and non-beta lactam facility, oncology and virus vaccines.
The oncology/cancer manufacturing facility will be completed soon. Further, the virus vaccines facility, expected to be completed next year, will produce a range of vaccines, including tetanus, hepatitis B, and HPV bivalent vaccines.