Production and Analysis Site


The plant in Anagni

The So.Se.PHARM Production and Analysis Plant is located in Anagni (Province of Frosinone, about 50 km from Rome) and produces pharmaceutical products and medical devices for own marketing company So.Se.PHARM and for generics/equivalents market.

The production is destined for all the countries worldwide that recognize EU-GMP and ISO 9001 certifications. The site is regularly inspected by the Italian Drug Agency (AIFA), various Ministries of Health and by clients (audit inspection). By now, the site produces as contractor for about 60 Italian and international pharmaceutical companies.

The production site is specialized in manufacture and packaging of drugs and medical devices in 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).

Furthermore, the production site in Anagni produces Bacillus Clausi raw material, with its coverage in ampoule in a separate and dedicated area.

The staff account for 330 persons employees (including 65 university graduates and other specializations).

The current production capacity is exploited to about 90 million units per year.

Contract Manufacturing Production:

The maximum capacity of the plant is impressive and accounts for about 200 million units per year of the major pharmaceutical forms. From those data, it can be observed that a large capacity is still released and it’s potentially available to any partner. The logistically good plant position in the vicinity of ports, airports, railways and highways, the high technological level of production facilities, the quality system, safety and environment certifications, the seriousness of company management, provide the highest quality /price ratio products.

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).

Plant Dimensions

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

  • 5000 square meters dedicated to the production departments
  • 4000 square meters dedicated to store materials and finished
  • 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

Contract manufacturing

The production capacity of the plant is impressive and is around 170,000,000 packs a year of the main pharmaceutical forms. This production capacity is the result of continuous economic investments in production and analysis machines, under the general summary scheme including year of introduction and implementation:

Machinery:

N.3 TABLETTING MACHINE (IMA & RONCHI) 2012
N.1 CAPSULES FILLING MACHINE MG2 2012
PACKAGING LINE 5: NEW BLISTERING MACHINE GNUDI PARTENA 2013
PRIMARY & SECONDARY PACKAGING LINE MARCHESINI (SACHET) (LINE 3) 2013
N.1 TABLETTING MACHINE (RONCHI) 2013
N.1 TURBO EMULSIFIER 2013
N.1 FILLING MACHINE FOR TUBE (COMADIS) 2013
N.1 CAPSULES FILLING MACHINE MG2 2013
N.1 ROTOGRANULATOR ROTOCUBE 600 IMA 2013
N.1 FILLING MACHINE FOR SUPPOSITORIES 2013
N.1 COATING MACHINE IMA GSHT300 2013
N.1 TANK 2000LITERS 2013
N.1 MACHINE FOR PELLETS 2014
PRIMARY & SECONDARY PACKAGING LINE GNUDI PARTENA / MARCHESINI (LINE 10) 2014
N.1 AIR BED FLUID HUTTLIN (200 LITERS) 2014
SECONDARY PACKAGING LINE FOR LIQUID ( LINE 7 ) 2014
N.1 FILLING MACHINE FOR EFFERVESCENT TABS MARCHESINI MT1000 2015
NEW LINE STICK PACK LIQUID 2015
NEW LINE PRIMARY & SECONDARY PACKAGING LINE MARCHESINI FOR SACHET (IN PROGRESS) 2015
N.1 AIR BED FLUID IMA GHIBLI (1200 LITERS) 2015
N.1 TABLETTING MACHINE MANESTY 2015
N.1 STRIP MACHINE FOR EFFERVESCENT TABS MARCHESINI MT 200 MINI 2016
N.2 TABLETTING MACHINE (RONCHI) 2016
NEW LINE PRIMARY & SECONDARY PACKAGING LINE MARCHESINI FOR STICK PACK SACHET (IN PROGRESS) 2016

Analytical Instruments: nr. 207 (of which 20 are HPLC).

As can be understood from these data, it results in a large production capacity available to partners requesting production for their products.

The logistically favorable layout of the plant near ports, airports, railways and highways; the high technological level of the plant; the certifications of the quality, safety and environment system; the seriousness of the company management, guarantees products of high quality / price ratio.

Pharmaceutical development

Pharmaceutical development services are also available for other third parties. The pharmaceutical development department offers a flexible and professional organization for activities concerning pre-formulation studies, formulation development, analytical development, validation activities, stability and production studies for clinical studies and implementation of updated and consistent CTD registration dossiers. and in eCTD (from the near future).

The main tools dedicated to development activities are:

Fluid Bed Dryer Nicomac 8 liters
Coating machine Nicomac 12 litres
Tabletting machine Ronchi PA10
Rotolab IMA 3 litres
Differential Scanning Calorimetry (DSC)

Molecular Plantation: The Research and Development Center (Anagni)

The new structure, conceived, designed and developed by Special Product's Line, uses Molecular Farming technology (genetically modified plants) to offer innovative biosimilar therapeutic solutions of Rituximab for the main diseases, such as non-Hodgkin's lymphoma, chronic lymphatic leukemia, rheumatoid arthritis , granulomatosis with polyangioite, idiopathic thrombocytopenic purpura, pemphigus vulgaris and myasthenia gravis.

The plant will allow the production of highly specific biological drugs so far obtained with expensive recombinant engineering systems. Instead, the process developed through the extraction of the active ingredient from rice will allow important economic savings in Italian and international health systems and will reduce the occurrence of adverse events in the same patients who use Rituximab.

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.