Contact us

Tel: 732-225-2930

Fax:732-225-6334

Email:info@austarpharma.com

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
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)
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
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