Evidence map›Paper›PMID 41551240›Full record

ReviewJournal of pharmaceutical policy and practice2026

Adoption of international good manufacturing practices in the Nigerian pharmaceutical industry: promising results from a decade of investment.

Moji Adeyeye, Obinna Ekwunife, Mopa Esuga, Nenye Njoku, Kwasi Boateng, Uzoma Ezeoke, Frank Monemeh, Olakunle Ekundayo, Abbas Sambo, Emmanuel Ogwuche and 3 more

Abstract readReview
In one paragraph

Review in Journal of pharmaceutical policy and practice, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Moji AdeyeyeNational Agency for Food and Drug Administration and Control (NAFDAC), Lagos, Nigeria.
Obinna EkwunifeDivision of Population Health, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, New York, USA.
Mopa EsugaPromoting the Quality of Medicines Plus Program (PQM+), U.S. Pharmacopeial Convention, Abuja, Nigeria.
Nenye NjokuU.S. Pharmacopeial Convention, Rockville, MD, USA.
Kwasi BoatengPromoting the Quality of Medicines Plus Program (PQM+), U.S. Pharmacopeial Convention, Accra, Ghana.
Uzoma EzeokeEmzor Pharmaceuticals Industries Limited, Isolo, Nigeria.
Frank MonemehPharmaceutical Manufacturers Group of Manufacturers Association of Nigeria (PMG-MAN), Lagos, Nigeria.
Olakunle EkundayoDrugfield Pharmaceuticals Limited, Ado Odo Ota, Nigeria.
Abbas SamboSwiss Pharma Nigeria Limited, Lagos, Nigeria.
Emmanuel OgwucheThe Former United States Agency for International Development (USAID), Abuja, Nigeria.
Anthony LongePromoting the Quality of Medicines Plus Program (PQM+), U.S. Pharmacopeial Convention, Abuja, Nigeria.
Jonathan UkwuruPromoting the Quality of Medicines Plus Program (PQM+), U.S. Pharmacopeial Convention, Abuja, Nigeria.
Jude NwokikeU.S. Pharmacopeial Convention, Rockville, MD, USA.ORCID https://orcid.org/0000-0003-4093-2606

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Despite Nigeria's robust pharmaceutical sector, no local manufacturer there achieved World Health Organization (WHO) prequalification before 2011. This contrasts with countries like South Africa, Morocco, Kenya, and Uganda, which have WHO-prequalified products and can participate in global medicine tenders. This study aimed to analyze successful initiatives supporting good manufacturing practices (GMP) standards in Nigeria, identify challenges hindering WHO prequalification, and proposed recommendations to enhance GMP compliance and facilitate WHO prequalification, aiming to strengthen the Nigerian pharmaceutical industry and improve access to quality medicines. Methods: A desk review was conducted to examine initiatives supporting adoption of GMP standards in Nigeria. rapid qualitative analysis techniques were used to interview key personnel involved in these initiatives. Interview data were summarized into predefined domains aligned with the interview guide and organized into a matrix, enabling descriptive analysis to highlight key points, narrative synthesis to construct a cohesive account of experiences, and interpretative synthesis to derive implications from the data. Results: Four major initiatives provided technical support to local pharmaceutical manufacturers, facilitating progress towards GMP compliance and enabling the first Nigerian pharmaceutical manufacturer to obtain World Health Organization prequalification (WHO PQ). Initiatives included: (1) WHO project from 2011 to 2014; (2) the Promoting the Quality of Medicines (PQM) program (2009-2020); (3) the PQM + program (2019-2025), both funded by the United States Agency for International Development (USAID) and implemented by the U.S. Pharmacopeia; and (4) a GMP roadmap project by Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC) and the United Nations Industrial Development Organization (UNIDO) (November 2018 - May 2019). Conclusion: Collaboration among NAFDAC, local manufacturers, the WHO PQ Team, and other partners enabled successful implementation of these programs, culminating in WHO PQ of Swiss Pharma Nigeria Limited's zinc sulfate dispersible tablets on June 6, 2023 - the first in West Africa. However, significant challenges persist, including insufficient understanding of WHO PQ requirements, inadequate GMP-compliant facilities, and financial constraints. Addressing these issues requires targeted interventions focused on GMP awareness, infrastructure investment, regulatory support, and harnessing Nigeria's potential as a pharmaceutical manufacturing hub.

Indexed as

Essential medicinesNigeriaPharmaceutical manufacturersPQM+Promoting the quality of medicines (PQM)USAID

Identifiers

PMID41551240
PMCPMC12805849

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.