Procedures for setting up a Pharmaceutical Production company in Nigeria


This article discusses in details, step by step procedures for setting up a successful Pharmacy or Pharmaceutical business in Nigeria including the requirements for doing so.

Pharmaceutical business is a vast one with high profitability potential especially if done the right way. Pharmacy business can be production or manufacturing, importation, exportation, distribution, wholesaling or retailing of Pharmaceutical products including drugs and devices.

Wholesale and retail pharmacies are commonly referred to as Community Pharmacy as they serve the community where they are situated in majorly.

Before we itemize the required steps for setting up a Pharmaceutical Manufacturing company in Nigeria, it is noteworthy to highlight certain factors that will help in the process.

First of all, you must be a pharmacist with some level of experience in Industrial pharmacy. For non-pharmacists who wish to set up one, you should have a seasoned pharmacist(s) with experience in manufacturing if you wish to thrive. You can visit Medical Jobs NG to place and advert for a pharmacist who would help you with the registration process.

Steps to open a Pharmaceutical Production company in Nigeria

The steps are as follows:

  1. Get a site preferably at an industrial zone where you can have easy access to power supply, clean water and access road to convey in raw materials from sea or airport and to convey out finished products.
  1. Get approval from Pharmacists Council of Nigeria, state the number of production lines you intend to start with, pay the necessary fees. Pharmacists Council of Nigeria is a government agency saddled with the responsibility of regulating Pharmacy practice in Nigeria.
  2. Before the number two, you must have registered your company with cooperate affairs commission (CAC) so that your company can be a legal entity. This will enable you transact business with both individuals and government agencies and establishments.
  3. Register your company with Pharmaceuticals Manufacturing Group(PMG), a group inside Manufacturing Association of Nigeria (MAN). Aside from the fact that you must join this group for some legal purposes, it will also help you in getting government waivers in tax, import duties and export tariffs.
  4. Source for capital to buy production equipments, build or rent a manufacturing house. In addition, keep running cost capital. It requires a large sum of money. So most times, personal savings cannot be enough. You may be required to seek for fund from Bank (loan), venture capitalist, Angel investors, friends and family contributions or Partnership.
  5. Employ qualified staff to ensure the smooth running of the company when it kicks off. Pay them well (within what is obtainable in the sector) so that they will put in their best in the course of discharging their duties.
  6. Employ good marketers and sales representatives. Give your products beautiful and up to date packaging. And don’t hesitate to recall any wrongly produced product. Don’t also hesitate in adding more products lines whenever the opportunity arises.

With diligence in handling the above steps especially proper registration with government agencies to avoid harassment, seeking for low interest loans and employing qualified staffs and managing your employees well, you will build a reputable company with annual high profit margin!!!

Who can open a Pharmaceutical Production company in Nigeria?

Any Pharmacist who is fully registered with Pharmacists Council of Nigeria (PCN) and have an NYSC discharge or exemption certificate is qualified to register any Pharmaceutical business be it Production, importation, exportation, distribution wholesaling or retailing. For non-pharmacists who wish to open manufacturing company, you will get to know what it entails as you go through the requirements below.

Requirements for opening a Pharmaceutical Production company

  • An application letter for premises registration
  • A completed PCN’s application form for the registration of the company. This is called form B
  • A photocopy of the annual licence to practice belonging to the superintendent pharmacist
  • Payment of prescribed location inspection and registration fees to the PCN. This is done through REMITA system.
  • Photocopy of resignation letter if you have worked elsewhere with with a photocopy of acceptance of the resignation
  • A letter of appointment into the new company if applicable
  • A legal agreement between the superintendent pharmacist and the employer if applicable
  • A CAC document of evidence of business name registration if Pharmacist owned
  • A certified copy of company’s articles and memorandum of association
  • A certified copy of particulars of the company’s directors as issued by the CAC
  • A photocopy of NYSC discharge or exemption certificate
  • An undertaking letter by the superintendent pharmacist stating that he has only one Pharmaceutical job
  • An undertaking letter by the managing director of the company stating that all activities relating to Pharmaceutical business of the company must be done by the superintendent pharmacist (if not owned and superintended by a pharmacist
  • If the Pharmacist was practicing in another state previously, a letter of transfer (interstate movement)
  • Evidence of a pharmacist in the board of directors
  • The current annual licence of the Pharmacist director
  • The list of products to be manufactured
  • The company’s organogram
  • The list of staff qualifications and duties
  • The factory layout
  • The Production flowchart
  • The list of Production and quality control equipments
  • The source of water and its treatment facilities
  • Both raw and treated water analysis report
  • The list and source of suppliers of raw and packaging materials
  • Standard Operating Procedures
  • Standard Cleaning Procedures
  • Disposal of poisons records

Note: All the enlisted letters to be submitted are to be written using the company’s letterheads paper.

As written by Pharm Marcel Nnadi (mPSN, B.Pharm)

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