The National Agency for Food and Drug Administration and Control (NAFDAC) has released a list of 101 pharmaceutical products whose registration certificates have either been withdrawn, suspended, or cancelled.
In a notice published on its official website on 19 September, the agency stated that the affected products are no longer permitted for manufacture, importation, exportation, distribution, advertisement, sale, or use in Nigeria.
Why NAFDAC withdrew the products
According to NAFDAC:
A product’s registration certificate is withdrawn when the Market Authorisation Holder (MAH) voluntarily discontinues its use.
It is suspended when the conditions under which the license was issued are no longer met, pending further review.
It is cancelled when the certificate is fully revoked by the agency.
Out of the 101 listed products, only four were cancelled, all produced by Gentle Hills Limited, while the rest were voluntarily withdrawn by their market authorisation holders.
Companies most affected
The list reflects the heavy concentration of approvals among a few multinational and local firms:
Servier Pharmaceuticals Development Ltd – 25 products (highest)
Healthline Limited – six products
MSD Idea Pharmaceuticals Nigeria Ltd – five products
Pfizer Specialties Limited – five products
Sanofi Aventis Nigeria Ltd – three products
Fensyl MHP Consulting Ltd – three products
Blooms Pharmaceutical Ltd – three products
Novartis Nigeria Limited – two products
AstraZeneca Nigeria Limited – two products
GlaxoSmithKline Pharmaceutical Nigeria Ltd – two products
Novo Nordisk Pharma – two products
Janssen Pharmaceuticals – two products
Other affected firms include Bayer East Africa, Johnson & Johnson, Cipla, Lyn-Edge Pharmaceuticals, Worldwide Healthcare Ventures, and F. Hoffmann-La Roche Ltd, among others.
Active ingredients most affected
The delisted products cut across chronic and infectious disease treatments:
Cardiovascular drugs – especially Perindopril and its combinations (12 entries), with Triveram (Atorvastatin/Perindopril) alone accounting for five.
Diabetes treatments – Sitagliptin (± Metformin) and Saxagliptin (± Metformin), each appearing four times.
Infectious diseases – Antimalarials (Artesunate/Amodiaquine, Artemether/Lumefantrine) and ARVs (Lamivudine/Nevirapine/Zidovudine) each appeared three times.
Other frequent drugs include Valsartan (antihypertensive), Paliperidone (antipsychotic), and Oxymetazoline HCl (nasal decongestant).
Dosage forms
Most of the affected products are tablets (≈75%). Other forms include:
Syrups, suspensions, injectables, sprays – three each (≈15.8%)
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