MILESTONES

The Company established in the 70's, on the foundations of the Gobbi Frattini family company, already present in the medical devices field. Haemopharm owes its success to a balanced synergy between its coherence to its own values, linked to tradition, and its constant impulse for innovation.

 

1960

The Family Company starts its activity as a forerunner in the automatic production of medical devices.

1978

Fondation of the Paolo Gobbi Frattini Company.

1985

Production Site license authorization for Medical-Surgical systems defined "Plastic Infusion sets for infusion and dialysis solutions", N. 800.5.OFF.820.3704.

1986

Commercial office establishment in Milan.

Ministry of Health Registration N. 15.828 of Combiset 2G, Infusion Set for infusion and dialysis solutions.

1988

Production site licensing for Medical-Surgical systems "Plastic containers and tubular systems for infusion solutions, dialysis solutions, blood, and blood derivatives" N. 800.5.OFF.820.2525.

1989

Ministry of Health Registration N. 14.928 of the Medical-Surgical empty bag system Autobag for infusion and dialysis solutions.

1993

Ministry of Health licensing N. 35243 for the commercialization of infusion and dialysis solutions listed in the national galenic formulary.

Ministry of Health licensing for the commercialization of the cumulative package 001 AC PRIMINGLine Na-Cl 0.9% solution in double bags for priming in haemodialysis, and infusion set Combiset 2G.

1995

Marketing Authorization licensing by the Ministry of Health for infusion and dialysis solutions packaging in bags, glass bottles and vials.

1996

Haemopharm Healthcare S.r.l. company constitution.

1997

Extension (900.2/16.SO.7.3934) of the Ministry of Health registration N. 14.928 of the Medical-Surgical empty bag system Autobag for drug reconstitution, called SHARPbag.

Extension (900.2/16.SO.7.3934) of the Ministry of Health registration N. 14.928 of the Medical-Surgical empty bag system Autobag for peritoneal dialysis system, called PERILine.

Ministry of Health Registration N. 14.928 of the Medical-Surgical empty bag system NUTRILine infusion set and bags for parenteral/enteral nutrition.

1998

UNI EN ISO 9002 certification n. 9120 PGBF. UNI CEI EN 46002 certification n. 9124 PGB2. ISO 9002 certification n. IT1592.

1999

Inauguration of the new plant in Tovo di S.Agata.

2002

Establishment of the Biofluids Division, for drug manufacturing and bag filling in Tovo di S. Agata.

2003

ISO 9001:2000 certification n. n. 9120 PGBF. EN 46002 ISO 13485:1996 certification n. 9124 PGB2.

 

 

 

2006

Marketing Authorizations for hemofiltration solutions in Austria N. 1-26257, 1-26258, 1-26259 e 1-26260.

UNI EN ISO 9001:2000 cert. n. 5783-A.

UNI EN ISO 13485:2004 certification, cert. n. 5783-M.

2010

Registration at the Colombian Ministry of Health N. 2010DM-0005986 of the medical device NUTRILine, infusion set and bags for parenteral and enteral nutrition.

2011

Constitution of the pharmaceutical company Quatalia Science d.o.o. in Belgrade, Serbia.

Registration at the Russian Ministry of Health N. FSZ 2011/10243 of the medical device Polyolefin bags for filling and storing infusion solution with components.

2012

Registration at the Venezuelan Ministry of Health N.30061090 of the medical device NUTRILine, infusion set and bags for parenteral andenteral nutrition.

Registration at the Colombian Ministry of Health N. 2010DM-0005986 of the medical device NUTRILine, infusion set and bags for parenteral and enteral nutrition.

Registration at the Russian Ministry of Health N. FSZ 2011/10243 of the medical device Polyolefin, bags for filling and storing infusion solutions with components.

 

UNI EN ISO 9001:2008 certification n.5783-A. UNI EN ISO 13485:2012 certification n.5783-M.

Opening of the Clinical Division Medical Center St.Agatha S.r.l.

GOLD WINNER at CPhI Pharma Awards “Best Innovation 2012” for the product NIV®: “Needle-free Vial closure system”.

2013

DMF n. 27342, Type III, submitted at FDA for "Plastic bags for Pharmaceutical Solutions and Their Components".

2014

Finalist at CPhI Pharma Awards “Packaging” for the product FILLChoice ROOM: a new concept of a compounding pharmacy incorporated in a bag.

2015

ADVATIS: joint venture between Siad Healthcare and Heamopharm Healthcare. The companies started cooperating to develop the SAFE2 line which includes different products that offer to the customers innovative and customizable solutions in the field of cell therapy.

Starting from July 1st 2015, the Individual Company Paolo Gobbi Frattini has become Paolo Gobbi Frattini S.r.l. (Sole Shareholder).

 

 

 

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