- 2015
- Successful FDA GMP inspection of manufacturing facility.
- 2016
- Lutrate® Depot Trimestral launch in Spain.
- 2015
- Lutrate® Depot 22.5mg approval in 23 countries in Europe.
- 2014
- Lutrate® Depot 3.75mg approval in Canada.
- Submission of Lutrate® Depot 3.75mg and Lutrate® Depot 22.5mg with US FDA through a 505(b)(2) procedure.
- Submission of Lutrate® Depot 22.5mg through a DCP in Europe.
- 2013
- Nictur® approval in 6 European countries.
- Successful Phase III clinical trial completion of Lutrate® Depot 22.5mg.
- 2012
- Submission of a new oral formulation for Desmopressin (Nictur®) in Europe.
- Lutrate® Depot 3.75mg approval in 23 countries in Europe.
- 2011
- First EU approval of Gemcitabine GP Pharm.
- First approval of Lutrate® Depot 3.75mg in Europe (6 countries).
- Start of the clinical trial of Lutrate® Depot 22.5mg in 24 hospitals in USA.
- 2010
- First EU approval of Oxaliplatin GP Pharm.
- 2009
- GP Pharm starts commercial activities in Spain and LatAm.
- First EU approval of Irinotecan GP Pharm.
- Submission of Lutrate® Depot 3.75mg through a DCP in Europe.
- 2008
- First EU approval of Octreotide GP Pharm.
- Successful Phase III clinical trial completion of Lutrate® Depot 3.75mg.
- 2007
- Cephalon (acquired by TEVA in 2011) appoints GP Pharm as exclusive worldwide manufacturer of Myocet® (liposomal Doxorubicin).
- 2006
- Start of clinical trials of Lutrate® Depot 3.75mg.
- First GMP approval (EMEA) and clinical batches in the liposomes and microspheres field.
- 2004-2005
- The manufacturing site was constructed including equipment for the new technologies: micro-encapsulation and liposomes.
- 2003-2004
- Starting the project. The entry of new investors.
- 2001
- First EU approval of Somatostatin GP Pharm.
- 2000
- The founders’ idea became a dream came true: GP Pharm was born.
Board of directors
Dr. Antonio Parente was born in Badalona (Barcelona) and he has been working in the pharmaceutical field for most of his career. He studied Chemistry and obtained his PhD in Organic Chemistry by the University of Barcelona in 1978. He owns furthermore an MBA by ESADE (1981) and a PADE (Senior Management Program) by IESE (2010) and is co-author of more than 60 research articles and patents.
Dr. Parente started his career in Laboratorios Vita S.A. where he worked as Director of the R&D and Patent Department. Since 1989, he has been co-founder of several companies, – including Lipotec SA, BCN Peptides SA, Diverdrugs SL, Lipofoods SA, BCN Corp SL and Primaderm SA – where he acted as Manager, Delegate Counselor or Administrator Counselor. In 2000, he founded GP Pharm where he is current President.
Besides these activities, Dr. Parente is at present President of the Business Council of the Centre for Genomic Regulation (CRG Barcelona), Vice-president of ASEBIO (Spanish Association of Biotech companies), Co-founder and Vice-president of CataloniaBio (Catalan Association of Biotech companies ) and Vice-president of Biocat (Foundation to Promote Life Science Sector in Catalonia). Dr Parente is former President of the Chemistry and Pharmaceutical Department of the Professional Association of Chemists of Catalonia (1980-1994) and former President of CataloniaBio (2010 to 2013). Finally, Dr. Parente is linked to more than 10 Biotech companies in Spain performing as a Consultant Assessor and/or Business Angel.
Mr. Josep de Nadal was born in Barcelona and is Chemical Engineer by Institut Químic de Sarrià (1968) and MBA by ESADE (1968). He started his professional career as Brand Manager in Danone S.A. (1968-1974). After that, he worked as Head of Division in MasCosmetics (1974-1976) and CEO of Ausonia Laboratories (1976-1992).
Mr. de Nadal professional activities from 1992 to 2010 included a wide broad of managing and consultant positions in several companies such as President in FINAF92 S.A., President in Naberoca Estate Agency, President in Doctoractive, Consultant in Arbora&Ausonio, Consultant in Angelini Pharmaceuticals or Consultant in IDESA Parfums. From 1997 to 2011, Mr. de Nadal worked in NH Hotels S.A. in different positions such as Shareholder Consultant, Independent Consultant and Chairman of the Audit Committee. Since 2010 Mr. de Nadal is Consultant in Ofistrade S.A., Senior Advisor in Clairfield Corporate Finance, Consultant in SOSA Ingredients S.L and Independent Consultant in GP Pharm S.A.
Mr. de Nadal has been Chief of IQS Foundation (2006-2008) and Professor at the Master in Management of Chemical Companies of IQS (1982-1987). He is currently member of the Cercle d’Economia and Vicepresident of Relleu Fundation.
Marta Parente has a degree in economics and business sciences from Pompeu Fabra University (2005) and an MBA from IESE (2010).
She started her professional career in the European Union, Chamber of Commerce, in Beijing, China, working in the field of health and cosmetics (2005-2008). After finishing her MBA at IESE, and working at Janssen Cilag SA, Madrid, she joined Roche in 2010, working at different areas of the company and in several markets (Roche Diagnostics in Sweden, Switzerland, and the USA; Roche Diabetes Care in Italy). Finally, she joined Genentech, the US subsidiary of Roche Pharmaceuticals, where she was responsible for global Market Access in the Skin Cancer division, Oncology, until 2015; head of the marketing team for the USA market, in Oncology; and as of 2017 she was the US East/Mid-Atlantic Sales Director in Oncology, Genentech.
In 2020, she joins GP Pharm as director of new projects and corporate feasibility and thereafter, assumes the role of COO of GP Pharm in 2021. In January 2022, she was appointed CEO of GP Pharm. Marta has been a member of the company's Board of Directors since 2017.
Management team
Ms. Mazó, MBA
QP - Site Manager
Mr. de la Fuente, PhD
Business Development Manager
Mr. Nicola, MSM
National Sales Director
Ms. Vázquez, PhD
Regulatory Affairs Director
Ms. Gambús, MD, PhD, MBA
Medical Director
Mr. Postigo, PhD
Contract Development & Contract Manufacturing Manager
Manufacturing Facilities
GP Pharm’s manufacturing facilities are located in a 35,000 square meters area at Sant Quintí de Mediona (50 Km west from Barcelona).
Newly constructed in 2005, the site was projected to be expanded with the company's growth. Nowadays, the facility consists of 8 isolated buildings of which 3 exclusively dedicated to production and the rest are devoted to offices, labs, logistics and utilities. The R+D and Quality control laboratories are located in the same area to easy development and validation of analytical methods. The simultaneous presence of our R+D and Production teams allow GP Pharm to establish a close collaboration between them to guarantee a smooth transition between development and scale up of industrial procedures.
Our manufacturing site offers advanced manufacturing capability and a wealth of technological experience where everyday a team of committed and competent employees work to develop and manufacture safe and efficient pharmacological products. The facility specializes in the production and packaging of:
- Drug Delivery Systems: Microspheres and Liposomes.
- Finished dosage forms of high potency drug substances (peptides, oligonucleotides, hormones, etc.)
- Finished dosage forms of cytotoxic active ingredients with indications for the treatment of cancer.
- Finished dosage forms of drug substances with an intermediate potency.
- Finished dosage forms of non-active buffers and reconstitution solutions.
GMP Approvals
The excellence of our Manufacturing facilities has been widely certified by the Good Manufacturing Practice (GMP) approvals of several agencies (including EMA and FDA) which clearly demonstrates our commitment with stringent quality standards. According to this, GP Pharm facilities are GMP certified by the subsequent Regulatory Agencies:
- Spanish Agency of Medicines and Sanitary Products (AEMPS), 2006
- Catalonian Health Service (SCS), 2008
- Pharmaceutical and Medical Devices Agency of Japan (PMDA), 2008
- Therapeutic Goods Administration of Australia (TGA) mutual recognition, 2009
- Gulf Cooperation Council (GCC), 2010
- Public Health Agency of Canada (PHAC) mutual recognition, 2010
- Turkish Ministry of Health, 2011
- Iranian Ministry of Health, 2011
- Ministry of Health of the Republic of Kazakhstan, 2013
- US FDA, 2015
Expertise Available to Partners
The Medical department designs and conducts the complete pharmaceutical development of our medicinal products.
Our extended know-how in different areas guarantees the fully and holistic development from preclincal to Phase IV clinical studies.
Our people have expertise in validation of clinical assays, design and conduction of preclinical studies, pharmacovigilance, biomarker development and regulatory aspects. We account with PhD, MD and Master degrees professionals in our team.
We assure the quality control, fully compliance with SOPs and enforce regulations and guidelines during all phases of the pharmaceutical development.
GP Pharm’s medical department assures the safety of the medicinal products (during the entire development and post-authorization) by the active monitoring of all pharmacovigilance aspects.
GP Pharm recognizes that a comprehensive intellectual property portfolio is of substantial value. It has developed original products and technologies and has generated an effective patent portfolio by focusing on obtaining quality patents that cover key products and technologies.
GP Pharm’s patent portfolio counts more than 100 individual patents and patent applications in about 50 different countries worldwide. Key products and technologies, such as controlled release systems, are protected by high value patents in the most important markets.
In order to ensure the proper storage of medicinal products under authorized conditions in GP Pharm warehouses a full integration of the supply chain from receipt, identification, storage, order preparation, documentation, shipping and distribution is made, keeping in any time a perfect traceability to product delivery to the customer.
GP Pharm is specialized in temperature controlled shipments worldwide, whether it is at room temperature (<25˚C), chilled (between 2˚ and 8˚C) or frozen (-20˚C) conditions. We work with the best suppliers of active and passive cold systems, choosing for each shipment the system that best ensures timely delivery and product quality.
The company also handles the export documentation according to the different regulations of each country in order to facilitate the process of importing the client and ensure a quick delivery to different destinations.
GP Pharm has a Regulatory Affairs Department with vast experience in national, European and US procedures.
The regulatory affairs capabilities of GP Pharm include:
- Preparation of new dossiers in NeeS and e-CTD format (both US and EMA environments)
- Audits of dossiers and DMFs.
- Submission and follow-up on dossiers, both national, European and US. We are able to handle national, MRP, DCP and CP procedures.
- Support in filing and maintaining Marketing Authorizations worldwide
Our Regulatory Affairs Department provides continuous support to our clients ensuring high-quality and timely registrations.
Membership
