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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.

21/12/2024

𝐓he 𝐂𝐀𝐑𝐁𝐎𝐍 𝐅𝐎𝐎𝐓𝐏𝐑𝐈𝐍𝐓 𝐎𝐅 𝐎𝐏𝐄𝐑𝐀𝐓𝐈𝐍𝐆 𝐑𝐎𝐎𝐌𝐬
In effort to improve individual and population health, healthcare systems ironically contribute significantly to globalwarming, a situation that cannot be ignored. (ORs), among the most resource-intensive areas in healthcare, play a major role in the sector’s environmental impact.

Studies reveal that healthcare systems account for 𝟑% 𝐭𝐨 𝟏𝟎% of national GHG emissions in many countries. For instance, the United States healthcare system contributes 10% of the nation’s emissions. If it were a country, it would rank 13th globally for GHG emissions, surpassing countries like the United Kingdom. Such data underscores the urgent need for reform within the healthcare sector to address its environmental impact.

Operating rooms are 𝐞𝐧𝐞𝐫𝐠𝐲-𝐢𝐧𝐭𝐞𝐧𝐬𝐢𝐯𝐞 𝐬𝐩𝐚𝐜𝐞𝐬, consuming three to six times more energy per square meter than other hospital areas. This is largely due to strict ventilation standards set to maintain clean air during surgical procedures. Heating, ventilation, and air conditioning HVAC systems alone account for 65% of hospital energy use, with ORs being the primary energy consumers. Simple measures like per hour during non-surgical hours can significantly lower energy use, carbon footprints, and operational costs.

𝐀𝐧𝐞𝐬𝐭𝐡𝐞𝐭𝐢𝐜 𝐠𝐚𝐬𝐞𝐬 like desflurane are particularly harmful, with emissions from a two-hour procedure equivalent to driving a car 608 kilometers.

Desflurane has nearly #20 times the global warming potential of and 2,600 times that of total intravenous anesthesia . Transitioning to less harmful anesthetics or prioritizing TIVA offers an effective pathway to reducing emissions compromising patient safety.

𝐖𝐚𝐬𝐭𝐞 𝐦𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 is another critical area. Single-use devices, often preferred for convenience and infection control, have led to a surge in medical waste, much of it plastic. Meanwhile, the improper disposal of anesthetic medications contributes to pharmaceutical contamination of groundwater and surface water. Hospitals must adopt sustainable waste management practices, such as reusing equipment where feasible and ensuring proper disposal of pharmaceuticals to mitigate their environmental burden.

Health professionals, hold a unique responsibility to lead by example. By embracing sustainable practices, such as reducing OR energy consumption, optimizing anesthetic choices, and minimizing waste, the healthcare sector can align its operations with global climate goals. These changes reduce emissions and demonstrate the health sector’s commitment to protecting the planet and, by extension, human health.

As continues to impact health systems worldwide, the need for low-carbon, climate-resilient health systems has never been greater.

Insightful piece from Kirigo Wachira 👏

20/10/2024

Egypt is Malaria Free!!! - Egypt’s malaria-free victory a blueprint for Africa’s health future - Bright Chimezie Irem

Today, Egypt celebrates a monumental achievement: becoming malaria-free, as certified by the World Health Organization (WHO). This is a huge milestone not just for Egypt, but for the entire African continent.

Why should we pay attention to Egypt’s success? It's simple. They’ve built a public health system that prioritizes effective vector control, strong healthcare systems, and cross-border collaboration. By focusing on what works and committing to the fight, Egypt has shown that malaria elimination is possible, even in regions historically affected by the disease.

But here's the key takeaway: Egypt's approach can serve as a blueprint for other African nations. Each country has its own challenges, but we can all learn from Egypt’s journey. By adapting their strategies to fit our own unique situations, we can all get closer to eliminating malaria across Africa.

It’s not just about government action. It’s about communities, healthcare workers, and regional cooperation.

Let’s take a look at Egypt’s playbook, see what’s working, and start applying the same principles where we are. A malaria-free Africa is within reach.

Source: Africa CDC

15/10/2024

Now, "talking" Healthcare Business in Nigeria - The Private Sector Contribution Aspect - Bright Chimezie Irem

Recently, we concluded a session as part of our Healthcare Business Optimization Sessions, we had some real and hard conversations about the tough road private healthcare operators and investors face in Nigeria.

It's no secret that running a clinic or a small and medium-sized hospital here feels like you're constantly battling frictions that could easily knock you out of the game. But here's the thing: those challenges can also push us to find better ways to survive and thrive.

We walked through design-driven, market-oriented strategies that improve operations and prepare healthcare businesses for growth and long-term sustainability. And it is clear: efficiency is the game changer.

What stood out?

1. Lean Operations are Key: By adopting simple tech-based solutions like electronic medical records and automated billing systems, you’re not just saving time—you’re cutting down on the inefficiencies that pile up. Some participants shared how they’ve slashed overhead costs by up to 30% just by integrating these systems. Imagine the possibilities!

2. Partnerships Can Unlock New Opportunities: We reviewed some successful partnership models; partnerships between private healthcare providers and local, state & federal governments (CBN, BOI etc) or larger healthcare networks. These public-private partnerships (PPPs) can bring in much-needed funding, and in some cases, increase operational efficiency by 20%. It’s a path worth considering, especially in our environment where capital can be hard to come by.

3. Data is Your Friend: Whether it’s tracking patient outcomes or forecasting needs, data helps us understand where to focus. One hospital operator shared how using data-driven insights led to a 15% improvement in patient satisfaction. Knowing your numbers helps you stay ahead of issues and improve overall service.

Why does this matter now?

In Nigeria, 70% of healthcare services come from private operators. If we optimize these systems and embrace a business mindset, we’re making our clinics and hospitals more efficient—we're building a resilient healthcare ecosystem that can withstand market challenges. It’s time for us to shift our approach, and build businesses that last.

Let’s keep the conversation going. What strategies have worked for you in your healthcare business?

23/08/2024

GIS and Health Development in Africa 🌍

In the passing week, I had a multilayer health development discussion in the form of teaching a cohort of on the subject of GIS and how we can deploy/harness the application of GIS to address some of our critical health development challenges in Africa.

After the class, my co-learners inspired me to summarize my thoughts and insights and share them with a larger audience, and I did so by drafting my summary thoughts under the title, "Geospatial Solutions for Improving Maternal & Child Health in Rural Africa - Bright Chimezie Irem

In rural Africa, maternal & child health outcomes are often compromised by limited access to healthcare services & a lack of critical infrastructure.

In Nigeria, for instance, maternal mortality rates stand at a staggering 512 deaths per 100,000 live births, while infant mortality remains high at 72 deaths per 1,000 live births.

These figures underscore the urgent need for solution & innovative approaches to healthcare delivery.

Geospatial Information Systems (GIS) are helping us yo create/design solutions by providing us with tools for mapping healthcare access, identifying underserved communities, and optimizing resource allocation.

In Nigeria's northern regions, where healthcare facilities are sparse, GIS analysis has revealed that over 60% of pregnant women live more than 5 kilometers from the nearest health center, exacerbating risks during childbirth.

By integrating spatial data with healthcare records, we can pinpoint high-risk areas, streamline the distribution of essential services like antenatal care, and deploy mobile clinics to the most remote regions.

For example, in Kenya, GIS-driven initiatives have increased antenatal care coverage by 25% in targeted rural communities, significantly reducing maternal & infant mortality.

GIS is not just a tool for mapping but a catalyst for actionable insights. It enables governments & NGOs to create targeted interventions that address the specific needs of vulnerable populations, ensuring that every mother and child, regardless of location, has access to life-saving healthcare.

With the help of geospatial solutions, we appreciate the fact that, data is more than just numbers — it's the key to unlocking healthier futures for mothers and children across Africa.

Ministry of Health and Family Welfare, Government of India , U.S. Mission Nigeria , Exchange Programs - U.S. Department of State UNICEF Africa USAID Global Health USAID - US Agency for International Development

18/06/2024

Harnessing Entrepreneurship and Enterprise Innovation to Tackle Africa's Health Challenges: Insights from the Africa Health Executives Conference - Bright Chimezie Irem

Africa faces unique health challenges that require enterprise innovative solutions. The Africa Health Executives Conference (ExCon), initiated by the Egyptian President, has a vision to help in transforming the continent's health sector through leadership, partnership for innovation, and sustainable health solutions. This conference is a platform for discussion and a structure for actionable change, inspiring a synergy between governments, private sectors, and entrepreneurs.Here's how health entrepreneurship and enterprise solutions can significantly impact Africa's health markets & ecosystem:

📌1. Innovative Health Technologies: Startups can develop affordable and scalable health technologies tailored to local needs. For instance, mobile health applications can improve access to medical information and remote diagnostics in rural areas. Integrating artificial intelligence in healthcare can also enhance disease surveillance and predict outbreaks, aligning with ExCon's mission to adopt advanced technology for better healthcare delivery.

📌2. Improving Healthcare Infrastructure: Entrepreneurs can collaborate with governments to improve healthcare infrastructure. This includes building efficient healthcare facilities and supply chain systems that ensure the availability of essential medicines and equipment. Such initiatives resonate with ExCon's goal of improving health infrastructure as a foundation for sustainable health development.

📌3. Training and Capacity Building: Developing human capital is crucial. Health-focused entrepreneurial ventures can provide training and capacity-building programs for healthcare workers. This initiative supports ExCon's vision of empowering healthcare professionals with the necessary skills to effectively address the continent's health challenges.

📌4. Public-Private Partnerships (PPPs): By promoting PPPs, ExCon encourages entrepreneurship in the health sector, facilitating better healthcare services through investments and shared expertise. These partnerships can lead to innovative financing models that make healthcare more accessible and affordable.

📌5. Focus on Preventive Care: Enterprises that focus on preventive care help reduce the burden on healthcare systems. This includes initiatives promoting vaccination, hygiene, nutritional awareness, and chronic disease management, supporting ExCon's mission to enhance public health and preventive care.

📌6. Local Pharmaceutical Production: Encouraging local production of pharmaceuticals not only reduces dependency on imports but creates jobs and builds local expertise. This aligns with ExCon's aim to strengthen Africa's pharmaceutical sector for health security.

By aligning these entrepreneurial efforts with the strategic objectives of the Africa Health Executives Conference, we can create an ecosystem where innovation thrives and health outcomes improve across Africa. The vision laid out by the Egyptian President AbdelFattah Elsisi - عبد الفتاح السيسي through ExCon is not just aspirational but a call to action for all stakeholders like Africa CDC to collaborate and innovate for a healthier African continent.

Afripharm Group|Afripharm Medicals (Ltd)

10/09/2025

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10/08/2025

21/12/2024

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23/08/2024

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