About Us

Established in the year 1991, SM Biomed Sdn. Bhd. is a leading manufacturer of Active Pharmaceutical Ingredients (APIs) and Intermediates based out in Malaysia With our state-of-the-art manufacturing facility certified by USFDA, EDQM, EUGMP and NPRA (Malaysia), we are dedicated to improve the quality of life through developing and delivering innovative solutions and products at an affordable cost.

With a legacy spanning more than three decades and pioneers for Macrolide based antibiotics, we work with customers globally with speed, efficiency and cost effective manufacturing capabilities. SM Biomed has grown as a market leader in Macrolides antibiotics and evolved into a knowledge driven company providing reliable pharmaceutical services including developing and manufacturing APIs and Intermediates. From pipeline to production, we make innovative, quality driven and customised products more accessible. We are a quality driven and R&D focused API manufacturing company with a diverse product portfolio catering various therapeutic segments.

We are poised to bridge the industry gap by delivering value-based products while maintaining focus on customer needs. We have state of the art R&D capability and market leading technology, 2 API manufacturing facilities armed with top of the line instruments with global approvals by USFDA, EDQM, NPRA etc. We stand by our vision to respect our partners through practicing the highest degree of professionalism by fostering individual accountability, reliability, continuous improvement, maintaining integrity and operational transparency, which we intend to achieve through developing utmost efficiency across the organization.

We recognize that trust is built incrementally project-by-project and we pride ourselves on the many deep, long-term customer relationships that underpin our business and demonstrate the value of the work we do.


Years of Excellence






in Macrolide Antibiotics

Evolution & Milestones


Company Registration


Commissioning of API manufacturing facility


Export Excellence Award from Ministry of Trade & Industry, Presented by Prime Minister of Malaysia


Awarded CEP for Erythromycin Base


Awarded CEP for Erythromycin stearate and Erythromycin ethylsuccinate


Awarded CEP for Clarithromycin


EUGMP Approval of our API Plant (through Bezirksregierung Münster)


Filed USDMF for Erythromycin base (DMF# 24956)


Asia Pacific International Entrepreneur Excellence Award


US FDA Approval of our API Plant


API-Australian TGA approval-Class-1


Filed USDMF for Erythromycin ethylsuccinate (DMF# 31754), Erythromycin base dihydrate (DMF# 32121) and Erythromycin stearate (DMF# 32120)


Awarded CEP for Erythromycin base dihydrate


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.

Our Mission

To make distinctive, eternal and substantial impact on the national, regional and global healthcare which can create global impact in manufacturing and supplying of quality medicines along with continous innovation in products and services.


SM Biomed’s manufacturing facility and products are approved by stringent regulatory bodies of the globe.

Market 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.


Year 2000
Export Excellence Award
Ministry of international Trade and Industry, Malaysia

Year 2012
Asia Pacific Entrepreneur Excellence Award