About Haemopharm Healthcare

Founded in the 1970s on the foundations of the family company Gobbi Frattini, a pioneer in the medical devices sector, Haemopharm Healthcare has achieved a leading role in the international market, qualifying itself as a leader in the infusion sector. The company is characterized by a very high level of specialization, a constant commitment to research and development of innovative solutions, and exclusive and proprietary technology of its machines.

The company potfolio includes a wide range of flexible PVC and PVC-FREE bags for sterile solutions, delivery systems and infusion components, for several pharmaceutical and medical applications. The company also offers a filling service that is carried out in Contract Manufacturing.

Haemopharm solutions are highly innovative, designed and manufactured entirely in house, in the Lombard plant of Tovo S. Agatha (SO), in compliance with the most rigorous and high quality standards.
Modular production management ensures maximum efficiency, through versatile and cutting-edge processes, high product reliability and constant performance levels over time.

“Innofamily since 70’s”

Over the years Haemopharm has always remained consistent with its identity values, rooted in the entrepreneurial history of the Gobbi Frattini family, which from the very beginning has played a leading role in the automated production of flexible bags for the biomedical sector.
Family tradition and innovation are effectively combined in Haemopharm’s claim – “Innofamily since 70’s” – which fully expresses the company’s identity and the foundations of its positioning.

The proprietary technology of the machines

In the 70s, Renzo Gobbi Frattini, founder of the company, personally designed the first generation of Haemopharm machines for the manufacture of biomedical sterile bags, making use of his expertise and passion in the engineering field. This added value has allowed the company to play a pioneering role and set new standards for the sector.
The machines for the production of sterile bags designed in house still represent a flagship of the company, and one of its most important competitive advantages.

The vocation to innovate is a “family” prerogative

The current owner Paolo Gobbi Frattini, head of the company for the second generation, has followed in his father’s footsteps with equal determination and success, focusing on the design of cutting-edge systems and components for drug delivery, developed and produced entirely in house. Many of these are patented and proprietary, with unique features on the market.

Direct commitment of the owner in the company management

The owner Paolo Gobbi Frattini, whose family owns 100% of the share capital, is present and operational in the Group, guaranteeing a long-term perspective. This is another key aspect of corporate identity, which facilitates communication, accelerates the decision-making process, to better meet the needs of customers.

Company Identity

A dynamic entrepreneurial spirit, constantly oriented towards the pursuit of excellence in over thirty years of history, places at the center of the Company’s strategy, three fundamental strategic assets that represent the Pillars of the Haemopharm Vision , and the foundations of its competitiveness:

Innovation

● OF PROCESSES, thanks to the proprietary technology of the machines, to the modular and versatile management of production;
● OF PRODUCTS, because the company develops solutions with advanced functional features, with high added value;
● OF COMPETENCES, because Haemopharm professionals have high-level specialist skills, always working with a cutting-edge design approach.

Diversification

Because Haemopharm solutions meet the needs of various therapeutic areas, such as pharmaceutical compounding, drug reconstitution, dialysis, nutrition, cryopreservation of cells and tissues, ozone therapy and ophthalmology.

Synergies

Because thanks to a consolidated network of partnerships and collaborations, Haemopharm is able to activate strategic collaborations along the supply chain, and to manage every phase of the project with the highest quality and efficiency, and in a short time.

Global competitiveness

The company’s mission is to consolidate its own leadership technologically, developing numerous patents and following a sustainable growth, as a partner of choice for big international entities.
Its international expansion strategy is included in a wider growth logic, oriented towards offering a modern and dynamic organization, capable of competing globally and being the first to reach specialist market areas with high quality products.

A worldwide commercial network

The global competitive ability of Haemopharm is an aspect of crucial importance of company policy. The customers, in facts, are increasingly sensitive regarding the launch of new business relationships with operators in the sector, who can not only offer an excellent product, but are also able to guarantee an extensive presence worldwide, thanks to the support of strategic partnerships.
For these reasons Haemopharm has developed over the years many strategic commercial agreements, thanks to which it is now present and active in many countries across Europe, North and South America, Australia and the Far East, thanks to which it is able to preside over the geographical areas of most interest to their business.

Direct presence in Serbia, through Quatalia Science d.o.o.

With headquarters in Belgrade, Quatalia Science d.o.o is a company controlled by Haemopharm which has been established to consolidate local business and to facilitate the emerging markets penetration. Quatalia also deals with the recording of numerous Marketing Authorizations, especially for oncological treatment, antibiotics and medical devices.

Competence and constant update on Regulatory Affairs

Both the companies – Haemopharm and Quatalia – have their own Regulatory Affairs departments, in charge of supervising the Marketing Authorization procedures, through dossiers preparation for drugs, and technical files for the CE marked medical devices..

FDA Certifications

The acquisition of FDA Certifications, necessary for the commercialization of medical devices in the USA, represents moreover an important step in Haemopharm’s development strategy.

Partnerships

A network of partnerships and business relationships, nationally and internationally, allows us to extend our range of action and activate synergies along the supply chain.
Thanks to the collaboration with accredited companies in the sector, Haemopharm is able to manage every phase of the project on behalf of the customer, and to propose high quality solutions, with maximum efficiency and in reduced times.

From the collaboration with SIAD, ADVATIS is born

In May 2005, Haemophorm signed o cooperation agreement with the company SIAD Healthcare for the development, production and marketing of a new line of bags for cryopreservation of stem cells and tissues: SAFE2.
The agreement with SIAD Healthcare expands Haemopharm presence in a new market segment and allows the company, through the Life Science Division of SIAD, to be supported by a trusted partner to continue the search for innovative solutions for cell therapies. The goal for both companies is to produce products that fully meet the stringent demands of the customers.

In 2015, the continuous collaboration with SIAD Healthcare becomes a contractual joint venture: nasce ADVATIS, “Advanced Therapies Innovative Solutions” is born, which provides the market with innovative solutions in the field of cryopreservation and cell therapy, offering a wide range of products that cover the different stages of collection, manipulation and preservation of stem cells and tissues.
Thanks lo a high level of flexibility and with the support of the R & D team, ADVATIS can offer tailored solutions to meet any customer demand.

From industrial research to treatment

Haemopharm is a unique entrepreneurial structure, due to its clinical division, the St. Agatha Medical Center, which faithfully represents the company’s DNA and its natural tendency to a tight collaboration with the medical-scientific world.

Corporate responsibility

The current and future success of Haemopharm Healthcare is grounded on a solid foundation of ethical values, at the core of its day-to-day activities which became the official operating guidelines adopted by the Company. Responsibility, an ethical approach to our work and the ability to form genuine partnerships with our customers, respect for people, the transparency of business activities, impartiality in the management of human resources, the honesty and clarity of contracts, a commitment to obligations undertaken, observance of the law, and respect for institutions in all countries across the world: these are the underpinning values, which are combined with a customer-oriented culture, with which Haemopharm aims to establish solid and lasting partnerships.
Haemopharm Healthcare is also responsible and committed to the environment, to sustainable development, to the search for technical solutions that enable us to make better use of resources and reduce environmental impact.




Milestones

1960

Constitution of the company Paolo Giuseppe Gobbi Frattini..

Constitution of the company Paolo Giuseppe Gobbi Frattini.

1978
1985

Production Site licensing authorization for Medical and Surgical devices defined as “Plastic infusion sets for infusion and dialysis solutions”, N. 800.5.OFF.820.3704.

Commercial office establishment in Milan.


Ministry of Health Registration No.15.828 of COMBYSet 2G medical and surgical unit for infusion and dialysis solutions

1986
1988

Production Site licensing authorization for Medical and Surgical devices defined as “Containers for tubular devices in plastic for infusion solutions, dialysis, blood and its derivatives”, No.800.5.OFF.820.2525.

Ministry of Health Registration No. 14.928 of the Medical-Surgical empty bag system AUTOBag for infusion and dialysis solutions.

1989
1993

Ministry of Health licensing No. 35243 for the commercialization of infusion and dialysis solutions listed in the national galenic form.


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 COMBYSet 2G infusion set.

Market authorization issued by the Ministry of Health for infusion and dialysis solutions packaging in bags, glass bottles and vials.

1995
1996

Haemopharm Healthcare s.r.l. company constitution

Extension (900.2 / 16.SO.7.3934) of the Ministry of Health Registration No. 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 No. 14.928 of the Surgical Medical Presidium empty bag system NUTRILine infusion set and bags for parenteral/enteral nutrition.

1997
1998

UNI EN ISO 9002 certification n. 9120 PGBF.

UNI CEI EN 46002 certification n. 9124 PGB2.

ISO 9002 certification n. IT1592.

Inauguration of the new plant in Tovo di S.Agata (province of Sondrio).

1999
2002

Establishment of the Biofluids Division, specialized in drug manufacturing and bag filling.

ISO 9001: 2000 certification n. 9120 PGBF.

EN 46002 ISO 13485: 1996 certification n. 9124 PGB2.

2003
2006

Market Authorization for Hemofiltration Solutions in Austria Nos. 1-26257, 1-26258, 1-26259 and 1-26260.

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

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

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

2010
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 solutions with components.

Registration N.30061090 at the Ministry of Health in Venezuela of the medical device NUTRILine infusion set and bags for parenteral / enteral nutrition.


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

2012
2013

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

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

2014
2015

ADVATIS: establishment of the joint venture between Medigas Italia Srl and Haemopharm Healthcare. The companies started cooperating by developing the SAFE2 line which includes different products that offer the customer innovative and customized solutions in the field of cell therapy.


Starting from 1 July 2015, the Individual Company Paolo Gobbi Frattini became Paolo Gobbi Frattini S.r.l. (sole shareholder).


The PAOLO GOBBI FRATTINI group expands the company by creating new areas for new productions. The company opens a fully operational compounding department suited for asepsis production of sterile fluids.


The MEDICAL CENTER ST. AGATHA expanded a lot of its areas too.

Creation of the iDone brand, a line of products dedicated to Ophthalmology..


Establishment of the company Lu Scientific d.o.o. in Belgrade, Serbia.

2016
2017

Creation of the Alimenta brand, a new line of bags for parenteral nutrition, produced with an innovative material that increases the quality of TPN bags.

ANVISA Regulatory Authorization n. 8047823 at the Brasilian Ministry of Health for Class III medical devices

2019
2021

Finalist at Tech beauty contest promoted by Digital Hub Lombardia (Confindustria Lombardia) for the category Digital Process Innovation with the proprietary online and line parametric and AI cam quality control.


Finalist at CPhI Pharma Awards for the category Packaging with the product CSTD REFill Kit, the ready to use Closed System Transfer Device for multivial drug reconstitution and administration.