AFAQUIM groups and represents a bunch of Spanish Manufacturers of Fine Chemicals, specialized in the Active Pharmaceutical Ingredients (API) and their derivatives.
26/02/2021REINSTATING EUROPE AS A GLOBAL HUB FOR ESSENTIAL MEDICINES19/01/2021Window of opportunity to enhance EU regulatory systems wide open as EU pharma strategy prioritises stronger EU networks30/11/2020The new Pharmaceutical Strategy for Europe is an opportunity to regain the european supply of Active Pharmaceutical Ingredients according to AFAQUIM
In the early 80s, started its activity the Spanish Association of Raw Pharmaceutical Materials (AFAQUIM), currently named Spanish Association of Fine Chemicals Manufacturers, aiming to consolidate a cooperation between the companies which produce something derived from the basic chemistry - Active Pharmaceutical Ingredients for the Fine Chemistry. AFAQUIM integrates 31 companies, some of them being part of international groups, while the majority are independent manufactuers.
Represent our Associates, defending their interests through "lobby" inside and outside the National and the European Union´s Authorities that regulate the activity of the sector.
Strengthen ties and work, hand in hand, with similar Associations from other countries, pursuing the harmonization of the inspection practices, supported and represented by the Corporate Institutions: FEIQUE and FedeQuim in Spain, and APIC-CEFIC, EFCG and Medicines for Europe in Europe.
Protection of the equality of the conditions of competition with the international contributors to the market, collaborating with the Regulatory Authorities in the preparation and implementation of the corresponding laws and of some fair and proportionate rules.
Speed the world´s access to the products of our manufacturers and the access of our manufacturers to all the possible markets, encouraging their expansion, stimulating export, attracting investments and supporting fair competitiveness.
Facilitate proper networking opportunities between our members through our thematic Committees (for the moment: Strategy, Environment and Quality), finding short and long-term solutions for the problems that all of us are facing.
Strive to improve the sector´s image in the society and become an Association of Manufacturers that are improving the quality of life by products created according to the highest security and quality standards, under strict environmental criteria.
Maintain a continuous formative work, which includes advertising relevant courses and trainings to our Associates, including some elaborated by AFAQUIM itself.
Keep our Associates informed and updated with notifications about upcoming national and international events, and other kind of development available, relevant to the sector´s activity, as like technical, economic and legislative guides intended to help with the legislative requirements and the compliance to the regulatory directives for API´s in general and GMP and GDP in particular.
They are the link between the basic chemistry, usually their suppliers, and the pharmaceutical industry, usually customers. The fine chemistry supports the tension from both ends and gives to its manufacturers differential characteristics. Among them:
- The product is of a high purity.
- The prices are generally high (up to thousands of $/ Kg)
- The global consumption sets a range that goes from hundreds of pounds to hundreds of tons per year.
- Qualifications, validations, approvals and authorizations are complex and very expensive.
- The considerations about the Industrial Property are decisive for the ¨to be or not to be¨ substance to manufacture.
- The technology is included in the definition of HIGH TECH
- The processes are usually multistage and such critical as the chemical part, might be the physic one.
- There are necessary major investments
- The design and development of the process requires complex structures with a high scientific content and long development time.
- The productive activities and processes are regulated
- Complex relationships with the environment nowadays determinants in manufacturing and development costs and which constitute the relational matrix of the fine chemical business.
- Government: National and International Health Authorities
- International agreements on industrial property or pharmaceutical harmonization issues
- Professional and Commercial Associations; Trade Unions
- Consumer Organisations
- The operating personnel must be properly trained and highly skilled.
- "Good Manufacturing Practices" (GMP) and Standards are the essential key.
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AFAQUIM, Spanish Association of Fine Chemicals Manufacturers
Marquès de Sentmenat Street, 54-58, 4th floor
08029 Barcelona, Spain.
Tel. +034 93 485 20 86.
Fax +034 93 485 56 53.