Saudi Pharmaceutical Industries & Medical Appliances Corporation (Spimaco) and Eli Lilly & Co have arrived at a manufacturing, commercial and technological agreement, under which Spimaco is licensed to manufacture “Tadalafil,” the most recent internationally approved medicine for the treatment of erectile dysfunction in males, the companies confirm.

This agreement will be valid for eight years. It also includes important elements of knowledge transfer in the fields of manufacturing, medical training and scientific promotion.
In the deal Spimaco is the first company in the world to obtain the right to manufacture and market Tadalafil under its own trade name Snafi. It is also the only company in the Middle East and Arab countries to obtain the right to market the product under its own trade name immediately after the approval and launch of Tadalafil in its first international markets.
This agreement provides both companies with the opportunity to partner with the medical community in providing patients with some of the world’s most innovative medicines, as well as presenting the best solutions and information to all medical sectors in the area, a spokesman said.
Spimaco actively promotes and distributes more than 100 products in Saudi Arabia and regionally. In addition to Eli Lilly, Spimaco has active licensing agreements with other leading multinational pharmaceutical companies. The relationships with these companies cover many activities in marketing sales and manufacturing.
When signing this agreement, both Spimaco and Eli Lilly took many factors into consideration, the most important of which is the success of Spimaco in technological and marketing fields, as well as the excellent reputation of the company locally and regionally, the spokesman said. Another important factor is the support that Saudi local industries receive from the government and Ministry of Health in securing leading medicines and technology transfer.
Spimaco’s strategy has been to develop business relationships with most of the existing players in the pharmaceutical market, taking advantage of their strengths, and specialisation, while it focuses on developing its own strengths in manufacturing, registration, sales and marketing.
Spimaco’s earlier relationships were structured whereby it would manufacture products on behalf of the overseas partner for all market segments. Spimaco would take on the role of sales and marketing at the Ministry of Health and other government institutions, in association with the licensors. Private market products would be manufactured by Spimaco and sold to the licensor’s distributors, while the licensor’s local office handled the marketing activities. The success of this business model attracted more multinationals to form new agreements with Spimaco.
Spimaco’s success in the private market persuaded some multinationals to grant it the right to develop second brands for their leading products. Thus, in addition to the launch of Snafi, Spimaco has launched Lorine, a second brand to Schering Plough’s Claritin, and Klavox, a second brand for GlaxoSmithKline’s Augmentin.
The company’s manufacturing facility is located at the heart of the industrial zone of Qassim, some 320 km northwest of Riyadh. The Al Qassim pharmaceutical plant covers 150,000 sq m, with a built-up area of over 60,000 sq m and is operated by 350 qualified professionals. From this central point products are distributed throughout the kingdom and other Middle East countries.
Production started in the first quarter of 1990 with six products only and increased to over 150 in 2001. Production capabilities include the production of oral solids, oral liquids, dry powders, injectables, ointments, creams, suppositories and various other forms. High standards of quality were planned from the outset. Spimaco selected a consortium of Roussel Uclaff (now part of Aventis) and UHDE the German Engineering Firm as a consultant to provide process and facilities design. Plans were reviewed by the FDA right from the planning stage to ensure full conformity. Human intervention was minimised through automation and closed continuous systems.
Spimaco was the first pharmaceutical manufacturing company to obtain ISO 9001 certification in Saudi Arabia and was also awarded the ISO 14000 certification, covering conformance to international environmental protection codes.
In 2000, Spimaco made a substantial step in its export activities by establishing its own company in Algeria, Societe Saoudiene Spimaco - Alger. The new company is responsible for importing, selling, marketing and distributing Spimaco products in Algeria. The company’s board has also approved investment with other partners to establish a pharmaceutical plant in Algeria. Spimaco is one of the major investors in this project along with Acdima, Saidal, Algerian JPM and Degromed. The new plant is expected to start operating this year, producing pharmaceuticals for the Algerian market and exports to the rest of Africa.