*Prof. Mojisola Christianah Adeyeye, FAS, Director-General/CEO of the National Agency for Food and Drug Administration and Control, declares the agency is excited about the World Health Organisation Prequalification (PQ) that has prequalified the Swiss Pharma Nigeria Limited鈥檚 second product 鈹�Antimalarial: Sulfadoxine/Pyrimethanine Tablet (SP Combination), making the company first indigenous Nigerian manufacturer to achieve 鈥榯his laudable feat in West and Central Africa鈥�

Isola Moses | 绿帽献妻

The National Agency for Food and Drug Administration and Control (NAFDAC) has expressed excitement about the World Health Organisation (WHO) Prequalification (PQ) prequalifying the .

绿帽献妻 reports the WHO Prequalification Unit May 2, 2023, had earlier added Pediatric Zinc Sulphate tablet (20mg dispersible tablet), manufactured by Swiss Pharma Nigeria Limited to its list of prequalified medicines (Swiss Pharma Nigeria鈥檚 dispersible zinc tablet prequalified.

Swiss Pharma Nigeria Limited … ‘a trailblazer, global supplier of quality essential medicines for public health programme’

Commenting on the feat, Prof. Mojisola Christianah Adeyeye, FAS, Director-General/Chief Executive Officer (CEO) of NAFDAC, said: 鈥淚 have the privilege of informing our stakeholders and the teeming Nigerian public, that the WHO Prequalification Unit has prequalified yet another product, Sulphadoxine/Pyrimethamine tablet from the same manufacturer to its lists of prequalified product.鈥�

The health sector regulatory agency, in a statement, Thursday, August 22, 2024, also noted that NAFDAC, set up by act of the Parliament (Act Cap N1 LFN 2004 as amended) to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, medical devices, packaged water, chemicals and detergents鈥� (collectively known as regulated products).

Adeyeye asserted that the development has thus made Swiss Pharma Nigeria Limited the first indigenous manufacturer in Nigeria to achieve this laudable feat in West and Central Africa.

She further stated: 鈥淭his is no doubt the outcome of meaningful collaboration between the Swiss Pharma Nigeria Limited and NAFDAC as well as a systematic implementation of policies earlier mentioned.

鈥淲ith this achievement, Swiss Pharma 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 in 2013, the manufacturer is now also the first manufacturer of finished pharmaceutical product to attain prequalification of 2 products in the West Africa and Central Africa Sub-region within the time space of 15months.鈥�

How the WHO PQ feat for Swiss Pharma’s tablet was attained, by Adeyeye

Going down the memory lane on how Nigeria achieved the WHO PQ for Sulphadoxine/Pyrimethamine tablet from the Swiss Pharma, the Director-General of NAFDAC explained the designated GMP inspectors in NAFDAC provided immense technical support prior to WHO鈥檚 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鈥檚 inspection.

The NAFDAC CEO further recalled: 鈥淭his is aside several face-to-face meetings, phone calls and virtual meetings with key personnel of Swiss Pharma Nigeria Limited.

鈥淭his additional feat without an iota of doubt has reinforce our belief that with the right attitude, collaboration, synergy and appropriate policies, Nigeria Pharma Industries can become a force to reckon with in the comity of nations.鈥�

According to Adeyeye, the current NAFDAC administration had for the umpteenth time reiterated its commitment to formulating policies targeted at enhancing capacity of local drug manufacturers that meet global Good Manufacturing Practice (GMP) standards. 鈥淭hese several policies which include the 5+5 policy, the expansion of NAFDAC鈥檚 ceiling list, new policy on establishment of Pharmaceutical Plants in Nigeria, the centralised GMP inspection for Pharma plants have convinced us beyond any reasonable doubt we are headed in the right direction to assure improved competitiveness of Nigerian Pharma Industry in the global space while projecting toward self-sufficiency in production of essential medicines,鈥� she said.

Swiss Pharma Nigeria Limited is a 鈥榯railblazer鈥�, global supplier of quality medicines: NAFDAC

Prof. Adeyeye also disclosed that with this achievement, 鈥淪wiss Pharma Nigeria Limited has undoubtedly, become the trailblazer, global supplier of quality essential medicines for public health programme, and is set to improve its fair share of the Pharma market.鈥�

She as well said the top Management of NAFDAC, therefore, encouraged other well-meaning local drug manufacturers to emulate this feat through harmonisation of collective aspiration and synergy of effort with the health regulator鈥檚 relevant Directorates.

鈥淲e can together as a team achieve more,鈥� declared the Director-General.

She also stated: 鈥淭his mandate no doubt bestow on the Agency the onerous responsibility of ensuring that only regulated products that are safe, effective and of the right quality are available and accessible for Nigerians at all times.鈥�

The Director-General said: 鈥淎s a customer-focused and agency-minded organisation, we are open to support more local manufacturers who have over the years shown a history of continued compliance to our extant regulations.

Together, especially at a time like this in our Nation鈥檚 history when the Federal Government has pronounced executive orders to support indigenisation of drug manufacturing, we can replicate this achievement and propel more local manufacturers to attain similar global recognition.鈥�

We’re honoured by WHO prequalification of our sulfadoxine-pyrimethamine drug, says Swiss Phrama Nigeria

In response to the WHO recent prequalification for its second product, Abbas Sambo, Business Development & Licensing Director of Swipha, said:聽“We are honoured by the WHO prequalification of our sulfadoxine-pyrimethamine drug, a testament to Swipha’s dedication to improving public health.

“This achievement reflects our commitment to producing high-quality medicines and contributing to the ongoing fight against malaria.”

According to the in a sttaement on its corporate Web site, with support from MMV and Unitaid, Swiss Phrama Nigeria Limited has become the first Nigerian manufacturer of WHO-prequalified sulfadoxine-pyrimethamine, used for preventing malaria in those most at-risk 鈥� children and pregnant women.

It stated that the milestone part of a broader effort to strengthen regional manufacturing capacity and expand the availability of quality-assured medications to combat malaria across Africa, where most malaria deaths occur.

The firm also explained that Nigeria records the highest number of malaria cases of any country in the world and relies solely on domestically manufactured sulfadoxine-pyrimethamine.

“Swipha undertook a detailed process to submit a comprehensive set of data about the quality, safety and efficacy of the product to WHO, with technical support from MMV and financial support from Unitaid,” said Swipha.

Swipha undertook a detailed process to submit a prequalification dossier to WHO for their SP 500/25mg tablet, starting with extensive research and development for product formulation followed by a bioequivalence study to assess efficacy and safety. This accomplishment was realized with the technical and dossier support of Medicines for Malaria Venture (MMV) and with funding from Unitaid. This joint effort was part of a broader initiative to increase quality, sustainable supplies of malaria medicines globally.

WHO鈥檚 prequalification programme ensures that medicines adhere to global standards of quality, safety and efficacy. Swipha鈥檚 prequalification adds to efforts to bolster regional medicine production and reduce overdependence on imported medicines, highlighted when the COVID-19 pandemic disrupted global supply chains.

Kindly Share This Story