History

S.M.B. was established in Brussels in 1953 with the task of delivering family medicines on the local market. In 1978, with the arrival of a new management team, the activities of S.M.B. focused on  innovative developments of oral drug delivery systems with the aim of bringing on the market  different products with unique features and positioning the company on a high added value sector (1980-1990).This policy came out with a significant effort in favour of the R&D sector in order to promote the creation of innovative drug formulations.

 With the arrival of new products, it became obvious and necessary for S.M.B. to find new markets. Obvious, because the company has always wanted to offer the best drugs to the greatest number of people; and necessary to cover the costs of the R&D and production.Indeed, the Belgian pharmaceutical market, although dynamic, remains relatively modest.

While production was originally located in Brussels, a  new manufacturing unit (S.M.B. Technology) was built in 1988 to meet constantly changing pharmaceutical and environmental guidelines as well as  international market needs.The factory complies with European GMP (Good Manufacturing Practice), is approved by Saudi, Jordanian, Yemen M.O.H and offers a flexible high potential of production to satisfy our worldwide partners.This manufacturing unit concentrates a significant part of the investments of the company in modern production and laboratory equipments to guarantee excellent volumes and quality.

 

MILESTONES

1953		Creation of Laboratoires S.M.B. in Brussels, Belgium
1978		New Managing Director, Mr. Ph. Baudier Collaboration with Professor Jaminet (university of Liege)
1988		Collaboration with S.M.B. Technology, exclusive contract manufacturer of Laboratoires S.M.B. in Marche-en-Famenne, Belgium
1994		Continued GMP compliance at both European and world level for the scaling-up of new and existing products
1998		ISO 9002 certification on June 25 for S.M.B. Technology Creation of Galephar Pharma GmbH (Germany) Marketing alliance with Glaxo Wellcome in Belgium & Luxembourg
1999		Creation of Galephar M/F First EU Divule® registration
2000		Orphan Drug Status granted for our novel mucolytic agent Nacystelyn, reference in the US (FDA) and in Europe (EMEA)
2002		First registration of once daily Tramadol in an European Reference Member State
2003		Approval of once daily Tramadol in 10 European countries by MRP
2004		Successful registration of Fenofibrate Lidose® in Canada Creation of Galephar TurkeyExport exceed 50% of turnover. Successful registration of Formoterol 12 µg DPI in Netherlands, Italy, Portugal, Germany, Poland,…
2006		Belgian registration of Isotretinoin Supra 8 – 16 mg
2007		First approval in South Korea : fenofibrate Lidose 160 mg
		First approval in Australia : omeprazole tablets
2008		Successful European registration of clarithromycin 200 mg once daily capsule
		First approval of buprenorphine sublingual tablet in Greece
		Exports reach 70 % of  annual turnover
2009		Lauch of Buprenorphine sublingual tablets in Greece, UK and Portugal.
2010		Approval of Buprenorphine sublingual in Germany
		Approval of Fluticasone DPI in Poland
		Approval of Formoterol 12µg DPI in Belgium
2011		Launch of Formoterol 12 µg in Belgium
		Approval of PRAVAFENIXTM in Europe by centralized procedure
		Approval of Buprenorphin in Czech Republic and Scandinavia