Are you planning to start a pharmaceutical business in Nigeria and don’t know where to begin? You’re not alone. The pharmaceutical industry is one of the most professional and heavily regulated sectors in Nigeria—and for good reason. It directly relates to the health and well-being of individuals, and compliance is non-negotiable.
In this guide, we’ll walk you through how to register a pharmaceutical company in Nigeria, detailing the regulatory requirements, documentation, and inspection processes involved. Whether you’re aiming to manufacture, distribute, or retail pharmaceutical products, this article breaks down everything you need to know to ensure compliance with the Pharmaceutical Council of Nigeria (PCN).
What is a Pharmaceutical Company?
A pharmaceutical company is a company that manufactures, distributes and retails drugs, poisons and devices. The company responsible for registering Pharmaceutical companies in Nigeria is the Pharmaceutical Council of Nigeria (PCN). Here is their Website https://pcn.gov.ng/
Categories of Pharmaceutical Premises
- Manufacturing: This manufacturing company must have a Production Pharmacist and a Superintendent Pharmacist. This category must be registered as a company.
- Wholesale/Distributor: There must be at least one registered pharmacist on the Board of Directors of the Company. The business must be carried out under the direct personal control and management of the Superintendent Pharmacist. This category must be registered as a company.
- Retail: The company shall be wholly owned by a registered pharmacist or in partnership with other registered pharmacist. This category can be registered as a business name.
Procedure for Registration with the Pharmaceutical Council of Nigeria (PCN)
- Submit an application to the Registrar, Pharmacists Council of Nigeria through the PCN state officer where the premises is to be located and operated.
- Attach the relevant documents to the application:
- Application letter to register the premises
- Duly filled Form B (PCN Application form for registration of premises)
- Photocopy of Annual Licence to practice and application for retention of name on the Pharmaceutical Register (Form J)
- Prescribed inspection and registration fees payable to the Council
- Letter of resignation from previous employment, if applicable
- Letter of acceptance of resignation, if applicable
- Letter of appointment in the new premises, where applicable
- Legal agreement between the Superintendent Pharmacist and his employer, where applicable
- Company’s Certificate of Incorporation (Evidence of registration of business name is acceptable from Pharmacist-owned retail premises)
- Articles and Memorandum of Association (certified copy)
- Certified true copies of Particulars of Directors as issued by Corporate Affairs Commission (CAC)
- Photocopy of NYSC Discharge or Exemption Certificate
- Letter of undertaking by the Superintendent Pharmacist to having only one full time job
- Letter of undertaking by the Managing Director of the Company to the effect that all pharmaceutical business shall be left under the direct, personal control and supervision of the superintendent Pharmacist
- Pharmacist’s inter-state movement Form (where applicable)
- Evidence of having at least a Pharmacist on the Board of Directors
- The application shall be accompanied with the Current Annual Licence of the Pharmacist Director
Where the pharmaceutical premises to be registered is a manufacturing premises, the following will be attached along with the above:
- List of products to be manufactured
- Organogram
- List of staff, qualifications and duties
- Factory layout
- Production flow chart
- List of equipment in production and quality control department
- Source and water treatment facilities
- Water analysis report of raw and treated water
- List and sources of suppliers of raw materials and packaging materials
- Standard Operating Procedures (SOPs)
- Standard Cleaning Procedures
- Evidence of payment of inspection fees payable to the Council
Inspection of the Premises
The inspection of all categories of pharmaceutical premises are carried out by Pharmaceutical Inspection Committee (PIC).
Some grounds rules for inspection must be followed and they include:
- The pharmaceutical premises must not be located in a motor park, environment close to a location where commercial activities and enterprise are standing and growing
- Must not be a market place including kiosks and roadside retail
- Pharmaceutical premises within a shopping centre shall not be more than three and they shall be well spaced out
- Pharmaceutical premises shall be sited not less than two hundred meters from each other
- If the pharmaceutical premises is surrounded or covered completely by a growing market or standing close to it, then the business must be moved to another suitable location two years after formal notification to do so by the Council
Expiration of License
All licence expires on the 31st of December of every year and it becomes due for renewal on the 1st of January of the following year. License must be renewed before 31st of January otherwise a penalty fee of 50 percent of the applicable fee would be attached.
Top 5 Pharmaceutical Companies in Nigeria: Products, Locations & Links
1. Emzor Pharmaceutical Industries Ltd
Emzor is one of Nigeria’s leading pharmaceutical manufacturers known for affordable and reliable healthcare solutions. Their major products include Emzor Paracetamol, Lokmal (antimalarial), Emvit-C (vitamin supplement), and Ibuprofen.
📍 Location: Plot 3C, Emzor Road, Ajao Estate, off Murtala Muhammed International Airport Road, Lagos
🔗 Website: https://www.emzorpharma.com
2. Fidson Healthcare Plc
Fidson is a respected name in Nigeria’s pharma space, known for innovation and high-quality medications. Key products include Astymin, Ciprotab, Mucotuss, and Peflotab.
📍 Location: 268 Ikorodu Road, Obanikoro, Lagos
🔗 Website: https://www.fidson.com
3. May & Baker Nigeria Plc
As one of the oldest pharmaceutical companies in Nigeria, May & Baker is known for trusted brands like Nivaquine (Chloroquine), Gentamycin Injection, Multivite, and Paracetamol Tablets.
📍 Location: 3/5 Sapara Street, Industrial Estate, Ikeja, Lagos
🔗 Website: https://www.may-baker.com
4. Swiss Pharma Nigeria Ltd (Swipha)
Swipha, now part of France’s Biogaran Group, is celebrated for its quality generics including Swidar (Artemether/Lumefantrine), Swisdol, Swiclox, and Swizole (Omeprazole).
📍 Location: 5/7 Industrial Estate, Apapa-Oshodi Expressway, Ilupeju, Lagos
🔗 Website: https://www.swiphanigeria.com
5. Neimeth International Pharmaceuticals Plc
Formerly linked to Pfizer, Neimeth delivers affordable health solutions with products such as Pyrantrin (dewormer), Homtamin G, and Neimeth Cough Preparation (NCP).
📍 Location: Plot 16, Neimeth Avenue, off Oba Akran, Ikeja Industrial Estate, Lagos
🔗 Website: https://www.neimethplc.com
FAQs on how to Register a Pharmaceutical Company in Nigeria
This can take between 4–12 weeks depending on your business category, state, and document readiness.
Include business incorporation documents, pharmacist’s license, SOPs (for manufacturers), and more.
Yes, but a registered pharmacist must be on the Board and act as Superintendent Pharmacist.
Costs vary by category and may include CAC registration, inspection fees, and pharmacist retainership.
Severe penalties may include closure, fines, license revocation, or criminal prosecution.
Yes, but only if it is wholly owned by a registered pharmacist.
Conclusion
A Pharmaceutical business can be registered with the Pharmacist Council of Nigeria under three categories: Manufacturer, Distributor or Retailer. All must be registered as a company except the retailer category which can be registered as a business name. However, in all three categories, there must be a registered pharmacist. Application to register the premises is made to the Registrar of the Pharmaceutical Council of Nigeria through the state officer of the PCN where the premises is to be located. All licence expires on the 31st of December every year.
Disclaimer: This publication has been prepared for general guidance on matters of interest only, and does not constitute professional advice. You should not act upon the information contained in this publication without obtaining specific professional advice. For specific legal advice, contact us:
Email: info@tcorporatelegaladvisory.com
Tel: 08103472195, 09080119975, 09080119980
Written by:
OGHENEYOMA ESTHER IBUJE LLB, B.L
T CORPORATE LEGAL ADVISORY
