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Formulation Research

Core Competencies

We undertakes formulation development of Pharmaceuticals ranging from immediate release formulations for oral administration to alternative dosage designs and controlled release formulations, aided by state-of-the-art technology and equipments. Formulation designs include Ethical Products.

Our R&D efforts are integral to business and devote significant resources towards R&D. We believe in the importance of developing R&D facilities and maintaining competitiveness.

Pharmaceutical Formulation Development

Our primary focus is on developing generic drugs at its state of the art facilities and creating a healthy basket of products for the domestic as well as the international markets. This involves:

  • Undertaking day one launches, which are launches of pharmaceutical formulations on the first day after the patent of a branded pharmaceutical formulation has expired
  • Managing the life cycle of products by developing new pharmaceutical formulations
  • Developing new drug applications and new dosage formulations for small molecules
  • Improving processes for existing pharmaceutical formulations
  • Developing formulations for niche products which have not been sufficiently exploited in the market
  • Developing non-infringing formulations for patented products prior to the expiry of the patent
  • Developing products based on NDDS
  • Developing hormones and peptides for regulated markets

Activities involved

  • Literature Information & Primary Patent Status Evaluation
  • Prototype Formulation Development
  • Packaging Development
  • Scale-up of selected Prototype Formulation
  • Process Optimisation
  • Process Validation
  • Manufacture of Exhibit/Bio-batch
  • Bio-Equivalence Study
  • Product Development Report
  • Documentation in CTD Format
  • Technology Transfer
  • Stability Study

Expertise In

  • Solid Orals
    • Tablets - Immediate Release/Delayed Release/Sustained Release/Effervescence/Soluble
    • Hard Gelatin Capsules - Granules in Capsule/Tablets in Capsule/Pellets in Capsule
    • Multiple Unit Particulate Systems (MUPS)
  • Parenterals
    • Liquid Parenterals - Ampoules/Vials/PFS
    • Lyophilised Products
    • Dry Powder Injectables
  • Topicals
  • Liquid Orals
  • NDDS

Pursuant to our efforts towards R&D, as of December 31, 2012, our R&D (erstwhile Astron Research Limited) has been granted 16 patents and has 71 patent applications in India and 35 patent applications internationally.