Polypharma Technologies & Sciences GmbH

Polypharma Technologies & Sciences GmbH (Polypharma) is a pharmaceutical consultant and supply agent specialized in supporting companies in the MENA region in the production of generics, including drugs, food supplements 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 provides end-to-end services that include consulting on construction and equipment of production facilities, compilation of drug technical dossiers, sourcing of pharmaceutical raw materials and development of detailed manufacturing processes.

Vision and Mission

Polypharma’s founding vision was to support the development of ethical local production throughout the MENA Region to combat counterfeited and sub-standard medicines, by partnering with selected companies who can develop sufficient and reliable local production.

To this end, its mission is to act as an expert and long-term partner in developing generic drug technical dossiers and assisting in technology transfer and local scale-up service at partner’s facility to accelerate acceptance of validation lots and reduce time to market for the highest quality finished products.

Products & Services

Core competencies of Polypharma include project planning, pharmaceutical R&D, dossier development, feasibility studies, plant construction, identification of new molecules, technology transfer, scale-up service, procurement and supply of raw materials.

Its comprehensive service offering can include all these elements to provide a total solution for pharmaceutical developers and producers, working in partnership with API developers and manufacturers.

Polypharma can provide production solutions for finished formulations including: antibiotics, alpha- and beta-blockers, alkaloids, analgesics, antacids, antidiabetics, antiemetics, antihelminthics, antihistamines, antimycotics, antiresorptives, cytostatics, corticoids, diuretics, hormones, immunosuppressants, schizonticides, antipsychotics, statins, virustatics, and vitamins.

It can also advise on finished formulations to address particular therapeutic classes, such as allergology, cardiology, gynecology, infectiology, parasitology, pneumology, ophthalmology, metabolism, diabetes, analgesics, psychiatry, anesthesia, dermatology, stomatology, neurology, rheumatology, anti-inflammatories, gastro-entero-hepatology and oncology.

These services include project planning, feasibility studies, plant construction, dossier development, raw material supply, and pharmaceutical development.

Polypharma can also process registrations, with on-site services that include all required API-manufacturer documentation, such as GMP, CPP, manufacturing license, and Drug Master Files (DMFs).

Company History and Structure

The company was founded in 1991 as Polypharma Import Export GmbH to develop trade relations previously established in various countries in Africa and the Middle East, based on the founder’s hands-on experience in projects in Mali, Tunisia, Burundi, Syria and elsewhere.

In 1993, the company became Polypharma Technologies & Sciences GmbH, expanding its activities to include the development of generic drug dossiers and DMFs. Over the following years it developed dossiers for a variety of products including dry, paste and semi-solid dosage forms, as well as suspensions, syrups and injectables before registering its first Polypharma dossiers in 1996.

In 2000, it obtained approval for commercialization of Narcotics and Precursors (category 1), swiftly progressed to create dossiers for dual and triple antiarrhythmic & cardiovascular therapies, as well as anti-diabetic drugs. In 2005, it expanded its portfolio to include cardiovascular dossiers and the following year developed its first dossiers for ophthalmic and nasal solutions as well as new technical dossiers for capsules, with the first successful creation of β-lactam antibiotics in powder form for oral suspension.

Following further expansions into neuroleptics as suppositories and tablets, corticoid creams, quinolone antibiotic tablets and veterinary dossiers, Polypharma made its debut as an exhibitor at the CPhI Worldwide expo in 2013.

Between 2018 and 2020, Polypharma played a crucial role in establishing a new pharmaceutical factory in Algeria, while simultaneously focusing on development of dossiers for dry forms, such as tablets, capsules and dry powder inhalers.

The company celebrated its 30^th Anniversary in 2021 with more than 200 successfully developed dossiers in-house and registered by partners, now including the majority of available pharmaceutical forms.

Throughout its history, the company has remained based in Hamburg in Northern Germany.

Quality, Regulatory and Standards

Polypharma’s operations and processes comply with Good Manufacturing & Distribution Practice (GMDP).

It is internally quality certified to ISO 9001:2015 and is a member of EUDRA-GMDP, holding commercial licenses for narcotics, drug precursors of category 1 and a wholesale license.

Polypharma works exclusively with partners who are GMP certified (or CPP certified in China) and have manufacturing sites that comply to ICH-Guidelines. Similar policies determine its choices of raw material suppliers and generics manufacturers.

To ensure the quality of the finished product, Polypharma provides an on-site service during the registration process, when test lots or validation lots are made.