So.Se.PHARM S.r.l. and Special Product’s Line S.p.A

Topline enterprise offering a broad range of solutions worldwide.

Today the group consists of two companies: So.Se.PHARM S.r.l., located in Pomezia (approx. 20 km from Rome) and Special Product’s Line S.p.A. (100% owned by So.Se.PHARM), located in Anagni (approx. 50 km from Rome) and counts approx. 300 employees.

The group is dynamic and flexible, the ideal partner in providing services covering the entire value chain for the development and production of generic pharmaceutical products relying on high quality standards and innovative technologies, a substantial added value we can offer to our customers.

Entrepreneurial spirit and ability to innovate with a long term vision allows the group to stay ahead of changes in the industry and invest in cutting edge solutions. The group takes pride in having all the equipment not older than five years.

The high level of technologies, quality certification as well as EH&S ensure outstanding quality of the products.

The operational excellence of the site is supported by established management and highly skilled workforce capable to handle current manufacturing processes and products as well as new projects implementation by relying on four core pillars: customer orientation, high flexibility, reliability and problem solving.


Special Product’s Line (SPL)

Special Product’s Line is the manufacturing site of the group, well located in the center of Italy whose core product lines is the production of solid dosage forms, semi-solid and liquid dosage forms.

SPL is authorized for the manufacture of not sterile products: Oral solid dosage (tablets, capsules, capsules in pellet, sachets, and oral effervescent); Semisolids (ovules, suppositories, creams); Liquid oral (stick packs, drops, syrups, oral suspensions) and has a long-standing expertise in pharmaceutical technologies and analytical testing of starting materials and finished products.


As part of the aggressive investment plan, the site is also taking new approaches, such as the biotechnology, the enhancement of effervescent production and the introduction of innovative pharmaceutical forms in non-sterile production such as stick packs (solids and liquids), as well as expanding the site expansion to 2 new departments (focusing on the increase of granulation capacity and the enhancement of stick pack production)

The site strives for quality and the highest efficiency for all process stages, besides So.Se.PHARM boasts the production of more than 500 pharmaceutical products supplied to more than 60 customers, top national and multinational companies.

The plant, designed to ensure the highest quality production standards in accordance with the GMP (Good Manufacturing Practices) and operate in full compliance with the EU and Italian law is approved by EMA Health Authorities, upcoming registrations in Canada, the US and Russia.


So.Se.PHARM

So.Se.PHARM S.r.l. markets generic drugs with its own brand name (branded generics), branded OTC medicines, medical devices, food supplements through the management of sales and distribution network of the drug (including direct supplies to pharmacies and hospitals) in the domestic market.

So.Se.PHARM is also active in the international market thanks to licenses and distribution agreements with major local companies. Consolidated partnerships have been already established in the EU and outside as the group is constantly seeking for international expansion.

Currently, So.Se.PHARM owns more than 60 Marketing Authorizations released by AIFA including the following pharmaceutical categories: urinary tract antibacterial, antihypertensive, hypercholesterolaemia, non-steroidal anti-inflammatory drugs, antihistamine, anti-anemic, asthma treatment, antidepressant, antifungal, analgesics, antipyretic, antiepileptic, antibacterials for systemic use pump inhibitors, treatment of benign prostatic, ulcerative colitis and Crohn’s disease, osteoporosis.


R&D

In addition to the activities of contract manufacturing for national and multinational companies, the Group boasts one dedicated R&D Department that manages the development of generic products and dossiers in an eCTD format for out licensing, the range of which spans from the Dossier portfolio and a large pipeline of drug product under development.

One of the most successful products developed and registered in several EU countries and outside Europe is Fosfomycin Trometamol in sachet.