Polypharma support for securing the pharma supply chain

Polypharma Technologies & Sciences GmbH (Polypharma) can provide advice and support to secure the supply chain in pharmaceutical industry new entrant product manufacturing of generic drugs and vaccines for developing markets, such as Middle East and North Africa (MENA) regions.

While Polypharma does not supply bulk medicines or bulk drugs directly, it can assist clients to ensure they source suitable quality supplies of the raw materials of pharmaceuticals at best value prices to support their own home-grown manufacturing.

Supply chain pharmaceutical expertise

Polypharma’s Pharmaceutical Raw Material Supply Service provides drug companies with the advice, information and contact they need to secure a guaranteed quality raw material supply chain, including API and excipient supply, that are manufactured exclusively in audited sites and certified to cGMP standards.

The supply of raw materials and supply chain outsourcing service form part of a suite of Polypharma services that accompany partners through all stages of the development and production of generic drugs, that also encompass market analyses, feasibility studies, design of product range, and technology transfer of production processes in manufacturing.

Procurement of active pharmaceutical ingredients and excipients

Polypharma can provide clients with access to its comprehensive database of pharmaceutical raw materials suppliers for sourcing materials and value-added ingredients.

The range of active ingredient (API) pharmaceutical supplies in the Polypharma database span all the leading pharmacotherapeutic groups, including antibiotics, macrolides, sulfonamides, alpha and beta-blockers, alkaloids, analgesics, antacids, antidiabetics, antiemetics, corticoids, diuretics, hormones, immunosuppressants, antidepressants, statins, and vitamins.

Similarly, the range of excipients available support raw material supply for all leading pharma manufacturing processes such as wet and dry granulation, direct compression and semi-continuous manufacturing, as well as production of dry powder inhaler products.

This procurement of raw materials support also extends to sourcing of materials to produce validation and industrial batches, and supply of reference substances, reagents and HPLC columns required for analysis.

Pharma supply chain management

Polypharma support for supply chain outsourcing is part of a wider pharma supply chain management offer in which all products are analyzed according to the current pharmacopoeias.

Polypharma’s laboratory equipped with HPLC liquid chromatography, UV and IR instruments can perform full quality control analysis on samples of all pharmaceutical supplies to be procured to ensure they meet the quality standards required to ensure full regulatory compliance for the final produced drugs, medicines and vaccines.

Polypharma can also provide the ingredient and raw material regulatory documentation necessary for the registration of compliant pharmaceutical dossiers with the health authorities, including DMF Drug Master File) or EDMF (European Drug Master File, GMP Good Manufacturing Practice documentation, and Manufacturing site licenses.

Contractually guaranteed supply of raw materials

Polpharma’s 360° service is secured by a long-term supply contract for pharmaceutical raw materials.

All raw materials for pharmaceutical industry sourced via Polypharma are supplied through Hamburg, where they are stored in an external GMP-certified warehouse, with permanent temperature control and humidity to guarantee appropriate storage conditions.

After an external quality control, a check of the good condition of the packaging and their labelling, the raw materials for pharmaceutical industry manufacture of the finished products are grouped together to proceed to a rapid delivery.

After the registration of generic drugs, Polpharma can then assist its partners to ensure the reliable supply of the pharmaceutical supplies they need to produce high quality drugs and vaccines.

Resources

Click on Raw material sourcing and supply for further information
Click on human medicines or veterinary medicines to access the lists of pre-validated generic drug dossiers available from Polypharma.