Brief History

Compliance

Corporate Social Responsability

EH&S

Brief History

Farmhispania Group consists of two companies in Spain: Farmhispania (Barcelona) and Rolabo (Zaragoza). Since its creation, it has constantly invested in equipment, new technologies and capabilities. Noteworthy investments include the installation of hydrogenation technologies in 2007, HPAPI handling capabilities in 2010, highly potent fermentation capabilities in 2014 and expansion of large scale preparative chromatography in 2015. Furthermore, Farmhispania Group has numerous ongoing collaborations and projects with various universities and research organisations both nationally and internationally.

FARMHISPANIA
BARCELONA

ROLABO
ZARAGOZA

Compliance

WORKING UNDER STRICT GMP GUIDELINES

More than

audits in the last

years

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Farmhispania and Rolabo are regularly visited and audited by our partners and customers (more than 75 audits in the last 5 years). Working under strict cGMP guidelines, we are also regularly audited by major World Health Authorities (USA FDA, Spanish AEMPS, Korean FDA and Japanese PMDA).

Since 1993, Farmhispania and Rolabo have received 12 FDA inspections.

The QA / Regulatory Affairs departments of Farmhispania and Rolabo have a long established experience with the latest quality and regulatory guidelines (CTD DMFs, LoAs, MRPs, deficiency letters, etc…) providing full support to our partners. Farmhispania and Rolabo have filed DMFs with major world Health Authorities and CEPs have also been granted.

More than 75 DMF’s submitted in the National Regulatory Agencies in more than 40 countries.
21 US Drug Master Files (DMF’s) submitted to the FDA.
12 Certificates of Suitability (CEP’s) granted by the European Pharmacopoeia.

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Working with integrity and ethical principles
Respect towards the employees
Quality assurance, quality of the products and continuous improvement
Health, safety and environment
Conflict of interests
Confidentiality
Defence of free competition

EH&S

Farmhispania was selected by the Pharmaceutical Supply Chain Initiative (PSCI) to be audited in September 2012. The PSCI is currently formed of 19 pharmaceutical companies of which Farmhispania is a key supplier for multiple members. The PSCI’s “mission is to establish formal industry guidelines about ethics, labor, health & safety, the environment and management systems and support suppliers to build capacity to operate in a manner consistent with those expectations.

For further information on PSCI and its member please click the following link:

http://www.pharmaceuticalsupplychain.org/

ENVIRONMENT

Environmental management handbook

Integrated plan for management/treatment of industrial waste

Cogeneration technologies in both plants to minimise natural resources consumption

WASTE HANDLING

Biological treatment by active sludge

Incineration

Waste water monitoring plan

SAFETY

Safety management handbook

Internal emergency plan

Medical service in-house

Safety committee

Occupational exposure control

Integrated training plan

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Brief History

FARMHISPANIA BARCELONA

ROLABO ZARAGOZA