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Afripharm Group|Afripharm Medicals (Ltd), Enugu (2025)

10/09/2025

Nigeria Drug Registration Pathways – Clear Guide

The National Agency for Food and Drug Administration and Control (NAFDAC) manages medicine importation and marketing in Nigeria.

The right pathway helps manufacturers avoid delays and enter the market with confidence.

1. Full Registration with NAFDAC

This is for new manufacturers whose products and facilities have not yet been audited.
Outcome Marketing Authorization is valid for 5 years.

Timeline
About 6–9 months, including dossier review, lab testing, and Good Manufacturing Practice (GMP) inspection.

2. Renewal of Marketing Authorization

For already registered products approaching expiry.
Outcome Extension for another 5 years.

Timeline
Apply 3–6 months before expiry with safety and pharmacovigilance data.

3. Post Approval Changes and Line Extensions

This is for changes in site, process, composition, packaging, or when adding new strengths.

Outcome
Approved variation or extension keeps the license valid.

4. Import Permit for Clinical Trials

For investigational products in approved trials.

Outcome
Permit to import limited quantities.

Timeline requires ethics approval and NAFDAC trial authorization, usually within a few weeks.

5. Port Fast Track Clearance
For registered products or materials.

Outcome: Quicker clearance within 24–48 hours.

6. Pre-Shipment Inspection and CRIA
For imports from countries like India and China, where NAFDAC recognizes accredited agents.

Outcome: Smoother border clearance and better documentation.

7. Technical Standards
Applications must go through the NAFDAC Product Administration and Monitoring System (NAPAMS) in Common Technical Document (CTD) format.

Module 1 requires corporate records, a Certificate of Pharmaceutical Product, a GMP certificate, and a Power of Attorney.

Generics must show bioequivalence or a valid waiver.

How AfriPharm Medicals Group Helps

AfriPharm Medicals Group partners with international manufacturers to:

Confirm eligibility and product class before filing
Run gap analysis on dossiers and documents
Prepare sites for GMP inspections.

File and track submissions on NAPAMS

Coordinate lab tests, CRIA, and port clearance

Maintain renewals, pharmacovigilance, and variations

With AfriPharm, global manufacturers can move from first interest to product launch in Nigeria within predictable timelines.

Connect with AfriPharm Medicals Group today to explore regulatory and distribution opportunities in Nigeria’s $4B pharmaceutical market.

07/09/2025

Nigeria’s Pharma & Health Market! Did you know?

Nigeria’s pharmaceutical market is valued at $4 billion and continues to grow yearly.

With over 250 million people and rising rates of diabetes, cancer, and cardiovascular disease, demand for quality medicines is increasing faster than domestic supply can meet.

Here are the hard facts:

More than 70% of the medicines on the shelves are imported.

The market is estimated at around $4 billion, driven by unmet health needs and population growth.

This means opportunity is right in front of us.

Nigeria needs reliable access to medicines.

Buyers are ready.

The delivery networks exist.

What’s missing is a partner who can enable smooth entry.

AfriPharm Medicals Group brings that partner to life:

• We offer a design-to-fit local distribution framework

• We guide manufacturers through the NAFDAC process efficiently

• We connect you/manufacturers with hospitals, pharmacies, and wholesale buyers

Suppose your company manufactures quality medicines in India, the USA, Egypt, China, Turkey, or Europe.

In that case, AfriPharm can help you enter the Nigerian market within months, backed by regulatory clarity and supply assurance.

Message us today to start your market entry journey.

15/08/2025

Nigeria’s pharmaceutical market. What matters now | Bright Chimezie Irem

Nigeria is the largest single pharmaceutical market in sub-Saharan Africa.

The market size is about $4B, and growth is near 9% a year.

Most medicines are imported, which creates headroom for manufacturers who combine capacity with strong local ex*****on.

Imports account for 70% of medicines used in Nigeria. Local plants run below capacity, so scale can shift quickly when a capable partner model aligns with precise regulation.

Regulation is shifting practically. Through NAPAMS and new guidance, NAFDAC has tightened and clarified device and product pathways. This reduces time and rework for entrants with complete dossiers and robust quality systems.

Coverage is expanding across programs. The National Health Insurance Authority (NHIA) created a stronger enrollment and purchasing power platform.

Government reports show that new enrollees have been added over the past 18 months, which improves the visibility of the demand for essential medicines and devices.

Policy support is strengthening.

Nigeria introduced tax measures to encourage local production and reduce import dependence.

World Health Organization (WHO) prequalification wins among local firms show quality progress and export potential.

Africa-wide demand is rising through 2030, reinforcing Nigeria’s role as a gateway market.

What wins in this market

■ Provide proven quality and reliable supply

■ Secure fast and clean registration and strong post-market vigilance

■ Invest in clinician education and hospital access, not only price lists

■ Compete in tenders with transparent service levels and high fill rates

■ Use risk-sharing structures that align incentives for sustained share gains

15/08/2025

Nigeria is the largest single pharmaceutical market in sub-Saharan Africa, and the opportunity in medical disposables is both immediate and measurable.

85% of Nigerian hospitals' syringes, catheters, infusion sets, and procedure packs are imported. Local production covers the rest, leaving space for manufacturers combining capacity with local ex*****on.

Hospital demand is shifting toward safe injection, sterile urology, and IV therapy products, while procurement reforms raise the bar on documentation and quality.

Recent regulatory updates from NAFDAC have streamlined the device pathway with dossier screening, NAPAMS onboarding, and clear submission channels, helping serious partners move faster.

Even in tight budget cycles, health spending remains a priority.

Nigeria’s pull within the broader ECOWAS market continues to drive demand from public programs, teaching hospitals, and the private sector.

For manufacturers looking at West Africa, the route is straightforward:

■ Bring proven quality & scale.

■ Match it with local registration, clinician engagement & tender capability.

■ Align incentives for long-term market share rather than one-off shipments.

That is where outcomes compound.

15/08/2025

AfriPharm Medicals Group 💊🩺

For over a decade, international pharmaceutical manufacturers have looked at Africa’s health market and seen huge potential, but there are also barriers.

High entry costs, regulatory complexity, and finding the right local partner often stand in the way.

AfriPharm Medicals Group exists to remove those barriers.

We are a market access partner based in Nigeria. We have the networks, know-how, and on-ground operations to connect your products to hospitals, pharmacies, and wholesale buyers nationwide.

What we bring to the table:

✅ Ready distribution network, reaching major cities and rural markets to the last-mile pharma retail networks.

✅ Regulatory support with NAFDAC for smooth product registration and approvals without costly delays

✅ Trusted buyer relationships as we connect you directly to decision-makers in the pharmaceutical and healthcare supply and value chain

Suppose you are a manufacturer in India, the USA, Egypt, China, Turkey, or Pakistan and want to explore Africa without the high setup cost. In that case, we’re the partner you’ve been looking for.

Send us a message today — your products could be in Nigeria in months, not years.

📩 AfriPharm Medicals Group – Your Bridge to Africa’s Pharmaceutical Future

15/08/2025

Breaking Through the Regulatory Barrier in Nigeria’s Pharma Market

For many global pharmaceutical manufacturers, the Nigerian market looks promising on paper: a $3B+ sector, 250 million potential customers, and demand growing faster than local production can keep up.

However, one hurdle prevents many companies from getting started: NAFDAC product registration.

The National Agency for Food and Drug Administration and Control is critical in safeguarding quality and safety.

The process can appear slow, complex, and unpredictable for an outsider.

Applications can sit in limbo for months, costing manufacturers valuable time and opportunities.

At AfriPharm Medicals Group, we understand this challenge because we’ve been on the ground for years.

We know the proper steps, the common mistakes to avoid, and the sequence that gets approvals through faster — without cutting corners or compromising compliance.

Our regulatory support is part of a complete market access package:

We prepare and submit your NAFDAC applications with accurate, compliant documentation from day one.

We coordinate product samples, laboratory testing, and inspections to ensure that the approval process is seamless.

We work directly with experienced regulatory desk officers and professional NAFDAC staff who have successfully laid out the path for this process.

For you, this means less uncertainty and a faster route to market.

Instead of waiting years for your products to appear on Nigerian shelves, you could supply hospitals, pharmacies, and wholesale distributors in months.

Suppose your manufacturing company is ready to enter Nigeria or West Africa but wants to avoid the most common regulatory roadblocks.

In that case, AfriPharm Medicals Group can be your on-ground partner to make it happen.

📩 Let’s talk. Your products deserve to reach the patients who need them most.

10/08/2025

Africa’s & Nigeria's Pharmaceutical Market Is Wide Open, And the Entry Window Is Now

Nigeria has depended on imports for most of its medicines for more than two decades.

Today, over 70 percent of the drugs used in hospitals and pharmacies here come from overseas, and that number is still rising.

Demand is growing fastest in life-saving categories such as ●Cancer Treatments
●Cardiovascular Medicines
●Antibiotics, and
●Diabetes Care.

The reason is simple: the population is large, young, and urbanizing, but health infrastructure and domestic production are not keeping pace.

This is more than an opportunity for manufacturers in:
India
The USA
Egypt
China
Turkey.

It is a clear, measurable, and scalable growth market. Yet many who have tried to enter independently will tell you the same story; they faced long delays with product registration, struggled to find credible distribution partners, and underestimated the complexity of building a reliable supply chain.

This is where AfriPharm Medicals Group steps in.

We do not ask for capital investment. We offer something far more valuable to a manufacturer looking at Africa for the first time:

Direct market access to a $3 billion Nigerian pharmaceutical sector and broader West African reach.

Established local supply chain connecting to hospitals, pharmacies, and wholesale networks.

Regulatory navigation to get your products NAFDAC-approved without the usual bottlenecks.

An on-ground business framework that lets you focus on manufacturing while we handle the market entry.

Let's discuss whether you produce quality medicines and want to see them on Nigerian shelves in months, not years.

AfriPharm Medicals Group is ready to be your bridge into Africa’s pharmaceutical future.

📩 Send a message or comment below, and let’s start the conversation.

Afripharm Group|Afripharm Medicals (Ltd)

10/09/2025

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