SM Biomed is the largest Active Pharmaceutical Ingredients (API) manufacturing firm based in Malaysia. The company is among the leaders in the therapeutic segments of Anti-infectives (Macrolide antibiotics) and Glucocorticoids (anti-inflammatory). Additionally, the company is well-represented in the anti-diabetic, and phosphodiesterase 5 (PDE5) inhibitors categories.
SM Biomed’s competitive edge is derived from its highly rated manufacturing facilities, research and development capabilities, vast domestic network, and global presence with over 500 clients spread across five continents. Approved by USFDA, EuGMP, TGA, KFDA and NPRA (Member of PIC/S), SM BIOMED leverages its strength of operational expertise and regulatory support in creating opportunities for our customers.
Our Journey
1991
Company Registration
1993
Commissioning of API manufacturing facility
2000
Export Excellence Award from Ministry of Trade & Industry, Presented by Prime Minister of Malaysia
2002
Awarded CEP for Erythromycin Base
2005
Awarded CEP for Erythromycin stearate and Erythromycin ethylsuccinate
2008
Awarded CEP for Clarithromycin
2009
EUGMP Approval of our API Plant (through Bezirksregierung Münster)
2011
Filed USDMF for Erythromycin base (DMF# 24956)
2012
Asia Pacific International Entrepreneur Excellence Award
2013
US FDA Approval of our API Plant
2014
API-Australian TGA approval-Class-1
2017
Filed USDMF for Erythromycin ethylsuccinate (DMF# 31754), Erythromycin base dihydrate (DMF# 32121) and Erythromycin stearate (DMF# 32120)
2020
Awarded CEP for Erythromycin base dihydrate
2022
Awarded GMP from NPRA, Malaysia (PIC/s member body) for newly commissioned Plant – II (Multipurpose manufacturing facility)
Our Vision
To be the first choice strategic partner for the pharmaceutical industry supplying Active Pharmaceutical Ingredients and advanced Intermediates based on innovation and robust technology without compromising on quality and affordability.
Accreditations
SM Biomed’s manufacturing facility and products are approved by stringent regulatory bodies of the globe.
Global Presence
SM prides itself on supplying quality goods at the right price coupled with excellent service to all their customers. With over 30 years of industry experience and willingness to collaborate with strategic business partners across the globe has enabled the company to expand its supply & market base to over 60 countries spanning 5 continents from Asia to America.
Awards
Year 2000
Export Excellence Award
Ministry of international Trade and Industry, Malaysia
Year 2012
Asia Pacific Entrepreneur Excellence Award