Polypharma support for generic medicine alternatives to branded drugs

Polypharma Technologies & Sciences GmbH (Polypharma) has developed a very wide range of market-ready drug dossiers for generic medications that meet the needs of developing pharma markets through encouraging local production.

These generic drug dossiers are part of a full-service end-to-end drug development offer available to empower potential producers across the Middle East and North Africa (MENA) region seeking fast track market-ready generic medicines to meet local and regional needs.

Full-Service Offer

The Polypharma Full Service encompasses all stages from development through registration process to production, with advice and resources available at each stage to generic pharmaceutical companies who need support in aspects such as project planning, sourcing raw material supplies, tech transfer, drug master file and dossier development, facility and lab construction and fitting out.

Polypharma has partnered numerous generic drugs manufacturers with many years of experience advising generic pharma companies in Northern, Western and Eastern Africa as well as across the Middle East.

Most recently, for example, Polypharma has provided support to a pharmaceutical company in Algeria with its project to start a new generic product line in Isotretinoin soft capsules for treatment of acne and skin cancers.

Polypharma’s inputs included advice on sourcing materials, as well as plant design and operation expertise, supervision of production of validation batches and all necessary documentation to register a marketable product with the Algerian Ministry of Health, moving on to production at full commercial scale.

Generic drugs dossier development

Polypharma is the ideal partner for manufacturers who are considering expanding their generics production line or establishing a new production site.

To date, Polypharma has developed many dossiers, covering the full range of generic pharmaceutical administration forms including generic pills, tablets, capsules, inhalers, suppositories, injectable solutions, infusions, nasal, ear and eye drops, syrups, oral solutions and suspensions and topically applied creams, ointments, gels, and patches.

As part of its service to generic drug manufacturers Polypharma offers dossier updates to meet variations, as well as being ready to study the possibility of developing new dossiers on request as well as being able to  develop API Drug Master Files (DMF) in cooperation with the manufacturer.

Each manufacturing dossier is accompanied by the regulatory documentation required for the registration of the finished product with the health authorities of the country to obtain market approval.

Generic pharmaceutical formulations

Polypharma’s mission is to apply its expertise in support of generic drug manufacturers in developing markets to speed the local production of therapies with a more affordable generic medicines price list, thus protecting patients from counterfeit, ineffective and expensive medicines.

Such markets urgently need generic medicines, meaning medications that have no clinically meaningful differences from original reference branded products and that are produced to the same regulatory standards previously approved for marketing by the FDA, EMA, and other international agencies.

For the generic medication to ‘inherit’ original approval, its dossier must specify the same derivation, route of administration, strength and dosage form, same identified benefits, and potential side effects. Where all these properties are in alignment, the generic drug will be regarded as being as safe and effective as the original patented one for approval purposes. Thus, the only real difference between branded and generic drugs is in cost to the consumer.

Polypharma generic drug dossiers

The Polypharma generic and biosimilar dossier portfolio covers all the significant therapeutic areas, including allergology, analgesics, anti-inflammatories, cardiology, gastroenterology, neurology, oncology, pneumology, and toxicology, as well as all the relevant administration forms.

Polypharma is also able to develop other generic drugs on request and after having carried out a specific feasibility study on the substance, including bioequivalence studies, where required.

In addition, Polypharma can provide support to comply with demanding FDA, EMA and other regulatory guidelines that apply to biologic manufacturing of generics and biosimilars, ensuring equivalent quality manufacturing standards that applies to the original biologic substance and compliance with Good Manufacturing Practice (GMP) requirements.

Resources

Click on A wide range of generic medicines to learn more.
Click on Polypharma human medicine dossiers for further information.
Click on Polypharma Full Service offer to learn more.
Click on Generic drug dossier development  for further information.