Production Analysis and Site

The plants in Pomezia and Anagni

The Production Sites and analysis of So.Se.PHARM are in Pomezia (25 Km from Rome) and in Anagni (Province of Frosinone at about 50 km from Rome) and produce pharmaceutical products and medical devices for own marketing company So.Se.PHARM and the generics/equivalents market.

The production is destined to all countries worldwide that recognize the certification EU-GMP and ISO 9001. The sites are regularly inspected by the Italian Drug Agency (AIFA), various Ministries of Health and by clients (audit inspection). At the moment the sites produce as contractors for about 60 Italian and international pharmaceutical companies.

The production sites are specializing in the manufacture and packaging of drugs and medical devices in the solid oral forms (tablets, coated tablets, soft capsules, rigid capsules, sachets and effervescents), semi-solid forms (ovules, pessaries, suppositories, creams, gels), liquid oral forms (drops , syrups, oral suspensions).

In addition, the production site in Pomezia produces injectable forms and drugs with high activity as beta-lactam antibiotics, while the production site in Anagni produces the raw material of Bacillus Clausi with its coverage in ampoule in a separate area and dedicated.

The staff amounts to 330 persons employed (including 65 university graduates and other specializations).

The current production capacity is exploited equal to about 90 million units per year, of which about 31% of beta-lactams, 19% of coated tablets, sachets of 14%, 12% of capsules, 11% of tablets and 10% of vials.

Contract Manufacturing Production:

The maximum capacity of the plants are impressive and are around 200 million units per year of the major pharmaceutical forms. As can be understood from these figures, it releases a large capacity that is potentially available to any partners. The arrangement logistically favorable of the plants in the vicinity of ports, airports, railways and highways, the high technological level of production facilities, the certification of the quality system, safety and environment, the seriousness of the company management, provide products of the highest quality /price ratio .

Pharmaceutical Development

Available for contracting manufacturing purposes, additional services including pharmaceutical development for generics/equivalent products out of patent. The department of pharmaceutical development offers a flexible and professional organization for activities relating to pre-formulation studies, formulation development, analytical development, validation activities, stability studies and production for clinical trials and implementation into congruent and updated registration dossier into CTD and eCTD (from July 2013).

Schematic Site Dimensions

The production site in Pomezia (Rome) spread over an area of ​​about 30,000 square meters of property of which 12,730 sq. m is the total useful surface and used as:

  • 6150 square meters dedicated to the production departments
  • 2300 square meters dedicated to store materials and finished products
  • 520 square meters dedicated to laboratories (chemical and microbiological)
  • 400 square meters dedicated to office
  • The rest of the technical area and equipment

The site of Anagni (Frosinone) covers an area of ​​over 40,000 square meters of which 18,000 square meters are used and used as:

  • 5000 square meters dedicated to the production departments
  • 4000 square meters dedicated to store materials and finished products
  • 500 square meters dedicated to laboratories (chemical and microbiological)
  • 2000 square meters dedicated to technical services
  • 500 square meters dedicated to offices.
  • 6000 square meters dedicated to Drug Development

Environment, safety, health

Environment protection (UNI EN ISO 14001:2004) and health and safety protection in the workplace are factors which further improve the business and the Group activities. By the way, behavioral safety standards have been established at company and individual department; furthermore, a system of observation of behaviors and standards took place and it will help to focus attention on safety aspects and to enhance the culture of co-workers on the prevention safety. The risk assessment and compliance with all existing legislation in environmental protection area, hygiene and safety at work, along with a full involvement of all company personnel, are key requirements to achieve levels of excellence in every area.

Smoke free

Smoking is banned inside the factories.