The addition of Paediatric Zinc Sulphate tablet (20 mg dispersible tablet), produced by Swiss Pharma Nigeria Limited (SWIPHA), to the list of World Health Organization-prequalified medications has been welcomed by the National Agency for Food and Drug Administration and Control.
Zinc sulfate is a medicine used to replenish low levels of zinc or prevent zinc deficiency in adult or children.
Also, Zinc deficiency can lead to loss of appetite, growth retardation and impaired immune function.
In severe cases, it can result in hair loss, diarrhea.
In a statement, Prof. Mojisola Adeyeye, the director general of NAFDAC, noted that the accomplishment was unquestionably the result of a fruitful partnership between SWIPHA and NAFDAC as well as the methodical application of policies.
SWIPHA Recognition By WHO
She said: “On the 2nd of May 2023, the WHO Prequalification Unit added Pediatric Zinc Sulphate tablet (20mg dispersible tablet) manufactured by Swiss Pharma Nigeria Limited to its list of prequalified medicines.
“This laudable feat is no doubt the outcome of meaningful collaboration between Swiss Pharma Nigeria Limited and NAFDAC as well as a systematic implementation of policies earlier mentioned.
“With this achievement, SWIPHA has added another first to its arsenal of firsts.
“Being the first manufacturer to be recognised by the WHO as operating at an acceptable level of compliance to GMP requirements in West Africa.
“The manufacturer is now the first manufacturer of finished pharmaceutical products to attain prequalification of its product in the West Africa Sub-region.”
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Quality Assurance For Medical Products
She emphasised that the Company’s heroic achievement of obtaining its product prequalified required a lot of work and self-determination.
According to her, NAFDAC staff gave outstanding technical assistance throughout the palatability studies for the now-prequalified product.
“WHO Prequalification is the fundamental prerequisite for quality assurance of key medical products to be purchased by UN agencies, and international organisations like Global Funds and United States Agency for International Development to procure and distribute products locally and internationally.
“Today SWIPHA has this opportunity. Therefore, it is a new source of business, and this will generate foreign currency for the company and Nigeria.”
Furthermore, she enjoined other frontline local drug manufacturers, in particular, to emulate this feat through the harmonisation of collective aspiration and synergy of effort with the agency.
“We can together as a team achieve more.
“As a customer-focused and Agency-minded organisation, our doors are open to serious-minded manufacturers who intend to achieve a similar feat and attain global recognition as provided by the WHO prequalification programme.”
