Transitioning from drug importer to producer in Africa and the Middle East – A Polypharma Guide

For pharmaceutical importers and distributors across Africa and the Middle East, the path to local generic drug manufacturing can seem daunting. The transition involves multiple disciplines- each requiring specialist expertise that most importing businesses do not have in-house. These capabilities include market analysis, facility construction, dossier development, technology transfer, regulatory registration and raw material supply.

Yet this transition is one that many companies have made successfully to reap significant rewards such greater control over supply, stronger margins, and the ability to market under their own labels. These re-energised producers also make a meaningful contribution to combating the counterfeit and substandard medicines that continue to harm patients across the region.

Polypharma Technologies & Sciences has guided importers and distributors through every stage of this journey for over 30 years, acting as a single long-term partner across the full transition – from the initial decision to explore local production through to first commercial batch and beyond. Here, they answer some of the most important questions about how and why to make the transition to full drug producer.

Why should a pharmaceutical importer consider making the transition to local production?

Importing medicines exposes businesses to risks such as global supply disruptions, currency fluctuations, long lead times, and the prevalence of counterfeit medicines in import channels. Local production can significantly reduce all these risks, creating greater operational and financial certainty.

Local production also allows companies to respond directly to market shortages, manufacture under their own label, and build a more defensible long-term business.

Polypharma has supported numerous importers and distributors across Northern, Western and Eastern Africa and the Middle East in making exactly this transition, drawing on over 30 years of experience in the region to guide partners from initial concept through to commercial production.

Where to start when planning a transition from importing to local pharmaceutical manufacturing?

The starting point is always the same – a thorough market analysis and feasibility study. Before committing capital, it is essential to understand which medicines are in consistent demand, where shortages or delivery failures occur frequently, what local production already exists, and what price-performance dynamics make particular generics commercially attractive.

Polypharma conducts detailed market analyses and professionally prepared feasibility studies for partners across MENA and Africa, examining the most important factors of the local generic market, estimating growth rates, assessing market size, and determining economic feasibility. This foundation ensures that investment decisions are grounded in real market data rather than assumptions.

How to determine which generic drugs to manufacture first?

Product portfolio selection is one of the most consequential decisions in the transition process. The goal is to identify medicines that are profitable in the long term, that will keep a production plant operational throughout the year, and that address genuine therapeutic gaps in the target market.

Polypharma advises partners on portfolio selection based on widespread local diseases, existing drugs on the market, supply shortages, the local distribution system, and prevailing price levels. With a large portfolio of successfully developed dossiers covering all major pharmaceutical dosage forms and therapeutic categories, Polypharma can also match identified market opportunities with proven, registration-ready products.

What infrastructure and equipment are needed?

The infrastructure required for a new generic drug production facility depends on which dosage forms a company intends to produce. Tablets, capsules, injectables, syrups, suspensions, semi-solid preparations and other forms each have distinct equipment requirements.

Polypharma provides consulting on construction and equipment selection for new pharmaceutical production facilities across Africa and the Middle East, including plant design, production layout optimisation, GMP compliance planning, and guidance on which additional equipment – such as specialised tablet punches – may be needed for particular products. For investors building from scratch, Polypharma supports the entire process from initial plant design through to operational readiness.

Why is technology transfer so critical in successfully launching generic drug production?

Technology transfer is the process by which the manufacturing and analytical knowledge embedded in a drug dossier is implemented at a partner’s production facility. It is not simply a document handover – it must cover the full production process including weighing and preparation of raw materials, production, primary and secondary packaging, analytical validation, process verification, quality control testing, and in-process troubleshooting.

Polypharma’s technical team can work on-site alongside the partner’s production and analytical staff during the manufacture of validation batches. By implementing the first production jointly, problems can be identified and resolved before they become regulatory or commercial issues, significantly reducing time to market.

What documentation is required to register a generic drug with health authorities in Africa and the Middle East?

Registration requires a complete drug dossier in CTD format, a Drug Master File (DMF) for the active ingredient, and additional API documentation including GMP certificates, Certificate of Pharmaceutical Product (CPP), and manufacturing authorisation.

Polypharma provides all the relevant documentation required for registration as part of its full-service offering. It can also accompany partners through the registration process with on-site support during test and validation lot production. Bioequivalence studies can also be arranged on request where required by specific health authorities, though these involve additional costs.

What ongoing support is available once local production is established?

The transition to local production does not end at first registration. Production scale-up, expanding the product portfolio, annual supervision of the production process, and ensuring a continuous supply of quality-assured raw materials are all ongoing requirements.

Polypharma provides long-term support through contractually guaranteed raw material supply – covering both APIs and excipients sourced from GMP-certified international manufacturers – as well as scale-up advisory services when upgrading to larger production machinery, and continued assistance with new dossier development as partners expand their generic portfolios.

The Polypharma Technologies & Sciences 360° service model means a company making this transition does not need to find separate consultants for each stage; Polypharma’s team of pharmacists, technicians and chemists works alongside partners at every step, including on-site during critical production milestones, working as long-term partners, rather than one-off transaction.

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