Manufacturing

Manufacturing

SM Biomed Sdn. Bhd. is a R&D backed API and Intermediates manufacturing company and also the first and largest USFDA approved API manufacturing facility in Malaysia.

We have two fully equipped production blocks in the premises. Plant-I dedicated for Macrolide antibiotics and Plant-II a multi-product facility with functional utilities including Steam, Chilled Water, Cooling water, Vacuum and Compressed air and multiple clean rooms.

Each of our facilities was built with quality, operational adaptability, and manufacturing capabilities in mind. With these attributes at our core, SM offers prompt production slots and uncompromising quality.

Plant-I

  • Dedicated facility for Macrolide antibiotics
  • Installed reactor capacity: 23.5KL
  • Annual production capacity: 200 MT
  • ISO Class 8 classified finishing area (Class 100,000 area)

Plant-II (Multipurpose Production Facility)

  • Multipurpose production facility offering greater flexibility
  • Specific production areas to handle different products
  • Ground +2 storey facility
  • Temperature capability: -80°C to +180°C
  • ISO Class 8 classified finishing area (Class 100,000 area)

Reaction Capabilities

Reaction Capabilities Reagent Capabilities
Grignard Reaction RMgX
Chiral Reduction S-CBS Reagent
Chemical Resolution (+)-CSA, L-(+)-Tartaric acid
Organoborane Chemistry Borane-Dimethyl Methyl Sulphate
Chlorination POCl3, HCl
Bromination Bromine / HBr in Acetic Acid, NBS, DBH
Nitration HNO3 / H2SO4
Reductive Amination Formic acid, Formaldehyde
Reduction NaBH4, K2BH4, LiAlH4
Cyclization Acylating reagent / AlCl3
Friedel Crafts Reaction AlCl3
Wittig Reaction Methyltriphenylphosphonium Bromide
Mesylation / Tosylation Methanesulfonyl Chloride,
Para-Toluene Sulfonylchloride
Methylation MeI/KOH, Dimethyl Sulphate / CaCO3
Demethylation N-Demethylation using Sodium acetate / I2, BBr3
Condensation Reaction EDCI / HOBT