Polypharma project planning for MENA pharma facilities

Polypharma Technologies & Sciences GmbH (Polypharma) is a pharmaceutical company that provides end-to-end services that include advice on construction and equipment of production facilities. These services are a core part of realizing Polypharma’s founding vision to support the development of ethical local production across the Middle East and North Africa (MENA) Region to battle against counterfeited and sub-standard medicines.

Polypharma partners with selected companies who can develop sufficient and reliable local production, and developing detailed manufacturing processes to support companies in the MENA market in generic pharma production of medicines, drugs, and biosimilars.

The company has many years of experience in advising generic manufacturers in Northern, Western and Eastern Africa, as well as in the Middle East.

Polypharma products & services

Core competencies of Polypharma include project planning, feasibility studies, plant construction, technology transfer, pharmaceutical development, and materials sourcing and supply.

Its full service offerings can include all these elements to provide a total solution for pharmaceutical developers and producers that can also include processing registrations, with on-site services that include all necessary API-manufacturer documentation, such as GMP, CPP, manufacturing license, and Drug Master Files (DMFs).

Feasibility studies

A thorough feasibility study is the normal starting point for any successful project. Polypharma offers its partners in the MENA countries, as well as in East and West Africa, comprehensive and professionally conducted generic drugs feasibility studies to secure the basis for years of sales success.

These feasibility studies are rooted in thorough and detailed market analysis, which is essential since actual generics production will be based on market needs, thus determining project feasibility. This market opportunity analysis should also determine disease prevalence and patterns, existing drugs on the market, gaps in pharmaceutical supply/provision, existing local production, available supply and distribution systems, prevalent pricing levels, tolerance and regulations, and estimation of achievable growth rate.

It is also necessary to examine feasibility of production, based on technical dossiers.

Project planning

Polypharma aims to act as a close partner across planning of all project steps to support customers according to their current equipment levels, in all stages related to the development and production of generics.

The project planning and facilitation service also encompasses:

• Advice on product range(s) to be manufactured
• Design of project timeline with milestones and KPIs
• Technology transfer of manufacturing and analytical processes
• Supply of raw materials for the production of validation and industrial batches
• Supply of reference substances and reagents required at the analytical level
• Supply of HPLC columns

Plant construction

Determined by market analysis and generic drugs production decisions, Polypharma can then offer professional support for facility construction, based on many years of experience in supporting private investors and companies in the development of MENA pharmaceutical facilities, as well as those in East and West Africa.

For the construction of a new pharmaceutical factory to succeed and result in years of successful generics sales, numerous factors must be taken into consideration:

• Market analysis: to include surveys of existing and planned competing sources and facilities in neighboring countries.
• Determination of product range: Depending on analysis of market and existing infrastructure, it is possible to stipulate the most sustainable and profitable range of medicines, drugs or generics to be produced range.
• Factory planning: Where all criteria are favorable, and depending on the fixed generics list and pharmaceutical forms, a detailed planning exercise can be carried out for the pharmaceutical production facility that will comply with the ICH guidelines and therefore GMP standards that are essential to be competitive in global markets.
• Process from raw material to finished formulation: Polypharma does not see itself as an investor, but as a skillful partner that can supports generic drugs producers in all aspects from delivering the dossier to manufacturing industrial batches, guided by realistic and carefully designed project schedule.
• Regulatory compliance: Complex pharma production processes requite many checks, tests and documents to be taken into consideration, including procurement of production and manufacturing licenses, manufacturing to valid technical dossiers, laboratory proving, and validation charges needed for the registration receipt of market approval.
• Subsidies: MENA countries are increasingly aware of the importance of developing local pharma production, with public financing funds set up to promote local initiatives. Polypharma can advise and guide clients through the grant application processes.

Resources

Click on Project planning for more information.
Click on Plant construction for more information.