Drug Development Technology & Services

AustarPharma has an experienced R&D team with deep scientific expertise and practical know-how in multiple drug delivery technology platforms. We have a wide range of pharmaceutical processing technology and capability to meet various development and manufacturing needs, whether it is a new chemical entity or a well-established drug molecule.

Our strong expertise in IP and technology assessment and experience with the FDA regulations and the U.S. generic pharmaceutical market also enables us to provide turn-key solutions to our international investors who want to enter into the U.S. generic market, from project evaluation to product development, bioequivalence evaluation, ANDA submission, commercial manufacturing and sales & marketing following ANDA approval.

Water-insoluble drug delivery technologies

Controlled-release (CR) platform technologies

• Osmotic pump

• Matrix (erosion/diffusion, diffusion)

• Film

• Pulsatile

Contract Services

• Formulation and analytical development

• CMC services of IND, NDA and ANDA applications

• Non-cGMP R&D manufacturing

• Clinical Phase I, Phase II and Phase III cGMP manufacturing

• cGMP Commercial manufacturing

Dosage form processing capabilities

• High shear granulation, fluid bed drying, milling and blending

• Fluid bed top spray granulation

• Fluid bed bottom spray pellet coating, drug layering (Wurster column)

• Roller compaction

• Nano crystal processing

• Tablet compression (single-layer, multiple-layer)

• Pan coating (aqueous, solvent)

• Capsule encapsulation (powder, pellet)

Drug Development Expertise

• Front line of world technology and research

• Strong pharmaceutical research, development expertise and capabilities

• Expertise in drug and project selection

• Familiarity with the legal environments in the US, EU, Japan & China

• Regulatory & FDA practices & experience