Before the Machine: The NAFDAC Gate No Tablet Press Gets Through

This is the post in the series we’d most like people to read before they enquire about a press.

A tablet press is legal equipment. You can buy one, ship it, clear it and install it. What you cannot do is press medicine with it. Those are different questions, and the second one is decided by NAFDAC and the Pharmacists Council of Nigeria long before the machine arrives.

Under the NAFDAC Act, no drug may be manufactured, imported, advertised, sold or distributed in Nigeria unless it’s registered. Not the factory. The product. Every strength of every product, separately.

The sequence, in order

Company incorporation. Corporate Affairs Commission registration, with pharmaceutical manufacturing in the objects. A business name won’t do.

A superintendent pharmacist. A pharmacist with a current annual licence to practise from the PCN, who takes professional responsibility for what leaves your factory. This is a real, full-time, senior appointment and it’s a permanent line in your cost base. It isn’t a name you borrow for the inspection.

Premises registration. The facility itself is licensed, and you’ll need a valid Premises Retention Licence. It’s renewed, not granted once.

Facility layout review. NAFDAC reviews the plan before you build. Material flow, personnel flow, airlocks, pressure cascades, segregation between dispensing, granulation, compression, coating and packing. As of June 2026 the agency had approved layouts for 176 pharmaceutical companies, 106 of which were new entrants. Submit the drawing before the blocks go up.

GMP inspection. Inspectors come to the site. They look at the building, the equipment, the utilities, the documentation system, the lab, the staff and the records. NAFDAC’s GMP expectations align with WHO-GMP, so WHO-GMP is the practical benchmark.

Product registration. Applications go through the NAPAMS portal. You’ll need a product dossier, certificates of analysis with stability data, label artwork for vetting, evidence of your brand name registered with the Trademark Registry under Class 5, your superintendent pharmacist’s licence, your premises licence, evidence of satisfactory inspection, and PMG-MAN membership evidence.

Only after all that does a tablet you press become a tablet you may sell.

How long, honestly

Nobody can give you a reliable single number, and be suspicious of anyone who does. The formal review timelines are defined, but the process stretches when inspection requests sit unanswered or when queries come back and the applicant is slow to respond.

What we can say from watching projects is that the delay is usually caused by the applicant, not the agency. Dossiers submitted incomplete. Stability studies not started early enough. Trademark registration left until last, when it has its own queue. Plan on this taking a good deal longer than your equipment lead time, and sequence your spending accordingly.

Why the enforcement is heavy right now

Nigeria has a counterfeit medicine problem that kills people, and the agency has stopped being polite about it.

In 2025 NAFDAC put the share of fake or substandard drugs in open markets at 30 per cent. Between February and March 2025 it cleared over 137 forty-foot truckloads of counterfeit and substandard product from Idumota, Onitsha and Ariaria. In February 2026 it seized more than 10 million doses of fake malaria medicine at the Lagos Trade Fair Market, and found warehouses of banned and unregistered medicine hidden in an uncompleted building in Apapa. Over three years the agency reports destroying around 1.5 trillion naira of fake product.

The convictions are the part worth reading twice. Between June 2025 and June 2026, NAFDAC secured 64 counterfeiting convictions. Sentences ran from one to seven years, without the option of a fine. Seven years for fake antibiotics. Five for a codeine cough syrup.

Customs is working the same problem from the port side. In July 2026 it handed over nine containers of narcotics, fake and unregistered medicines worth 53.39 billion naira in duty paid value, and has flagged fake NAFDAC registration numbers being used to bring unregistered drugs in.

What this means for equipment buyers

It means a tablet press installed outside this framework isn’t a business with a paperwork problem. It’s a criminal enterprise, and the people running it go to prison without the option of paying their way out.

We get enquiries that don’t sit right. Someone who wants a press but goes vague when asked which product and which registration. Someone who wants tooling engraved with markings that belong to a company they don’t own. Someone who wants delivery to a residential address. We don’t quote those, and we’d say the same to anyone sourcing on your behalf: a supplier who never asks these questions is not being easy to work with, they’re being careless with your name and theirs.

If you’re a legitimate manufacturer, none of this is bad news. The enforcement is clearing out the people who were undercutting you with fake product, and the 5+5 policy and Ceiling List are closing the import routes that competed with you. The regulatory burden is the moat.

The cheaper way in

If the licensing sequence reads as too much for a first venture, that’s a reasonable conclusion and not a defeat. Contract manufacturing exists precisely for this. The number of companies using it in Nigeria rose from 10 in 2019 to 87 in 2026.

You register the product, own the brand, and have it made in someone else’s licensed and inspected plant. No press, no HVAC, no superintendent pharmacist on payroll. There’s a separate post in this series on how that route works and what it costs you in margin.

This piece is general guidance from an equipment sourcing perspective, not regulatory or legal advice. For your specific product and facility, go to NAFDAC directly and take pharmaceutical regulatory counsel.