Custom Synthesis

Manufacturing / Synthesis of

• Active Pharmaceutical Ingredients (API’s) and Intermediates
• All types of Impurities (Organic, Nitraso amine impurities, Elemental impurities etc.)
• Reference standards

Formulation Development

Manufacturing support for different dosage forms like

• Inhalation Products
  

  - Dry Powder Inhalers (DPI’s)

  - Metered Dose Inhalers (MDI’s)

  - Nasal Sprays

• Solid Orals
  

  - Pellets

  - Tablets

  - Capsules

• Injectables
  

  - Solutions

  - Suspensions

  - Emulsions

  - Powders

  - Lyophilized Cakes

Technology Transfer and Dossier Support

• End to end support for Formulation development and Analytical method development of various dosage forms like Inhalations/Aerosols, Solid Orals and Injectable products
• Electronic Common Technical documents (eCTD) /Dossier support

Analytical support

• Method development and validation as per ICH guidelines
• All type of analysis for chemical substances and Finished products
• Nitraso amine impurities validation and analysis
• Elemental impurities analysis by ICP-MS, GC-MS and LC-MS
• Isolation and characterization of impurities and degradation products
• 2D-NMR analysis
• TGA analysis etc
• Certification of reference standards via full chemical analysis

Packaging Development

• Product Packaging Solution
• Packaging Graphic Design
• Device Development
• Packaging Prototyping
• Packaging Components Supply
• Art Work Development