National Agency for Food, Drug Administration and Control (NAFDAC) has announced that the World Health Organisation (WHO) prequalification unit has prequalified ulphadoxine/ Pyrimethamine tablet, a product of Swiss Pharma Nigeria Limited (SWIPHA), and added it to its list of prequalified products, making the company the first indigenous manufacturer in Nigeria to achieve the feat in West and Central Africa.

Director General, NAFDAC, Prof. Mojisola Adeyeye, yesterday, at a media briefing, said the feat was the outcome of meaningful collaboration between the Swiss Pharma Nigeria Limited and NAFDAC as well as a systematic implementation of certain policies.

Recall that on May 2, 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.

Speaking at the briefing, Adeyeye said with the achievement, Swiss Pharma had added another first to its arsenal of firsts. “Being the first manufacturer to be recognised by WHO as operating at an acceptable level of compliance to GMP requirements in West Africa in 2013, the manufacturer is now also the first manufacturer of finished pharmaceutical product to attain prequalification of two products in the West Africa and Central Africa Sub-region within the time space of 15 months.

“Our designated GMP inspectors in NAFDAC provided immense technical support prior to WHO’s site inspection by the prequalification inspection team and provided valuable insight into objective review of Corrective and Preventive Actions (CAPA) taken to address the few observed non-conformances recorded during WHO’s inspection. This is aside from several face-to-face meetings, phone calls and virtual meetings with key personnel of Swiss Pharma Nigeria Limited,” she said.

Speaking on the milestone, the Managing Director of Swiss Pharma Nigeria Limited, Frederic Lieutaud, said the achievement of WHO Prequalification for Swipha’s SP 500/25mg tablet underscored the company’s commitment to providing high-quality, life-saving medicines that meet international standards of safety, efficacy, and quality assurance.

He noted that the prequalification also represented a significant step forward in the fight against malaria in pregnancy in Nigeria and across Africa.

He said: “We are immensely proud to have received WHO Prequalification for our Sulfadoxine Plus Pyrimethamine Tablet for preventing malaria in pregnancy. This achievement demonstrates our unwavering commitment to improving maternal health and combating malaria, two critical public health challenges in Nigeria and beyond. We believe every woman deserves access to safe and effective preventive measures during pregnancy, and we are dedicated to making this a reality,” Lieutaud said.