Drug Reformulation and formulation services

Drug reformulation breathes new life into existing molecules by addressing limitations related to solubility, stability, bioavailability, patient compliance, or market differentiation.

Services

Development Batches & GMP Clinical Manufacturing Drug Reformulation and formulation services

Drug reformulation breathes new life into existing molecules by addressing limitations related to solubility, stability, bioavailability, patient compliance, or market differentiation.

1. Drug Reformulation Services

Drug reformulation breathes new life into existing molecules by addressing limitations related to solubility, stability, bioavailability, patient compliance, or market differentiation.

Key Offerings:

  • Bioavailability Enhancement:
  • Lipid-based formulations
  • Solid dispersions (hot melt extrusion, spray drying)
  • Nanotechnology-enabled delivery
  • Amorphous solid dispersions
    • Modified Release Formulations:
  • Controlled, sustained, delayed, and pulsatile release platforms
    • Pediatric & Geriatric Formulations:
  • Taste-masked liquids, orally disintegrating tablets (ODTs), chewables
    • 505(b)(2) Development Pathway Support (USFDA):
  • Strategic reformulations for market exclusivity and lifecycle management

2. Formulation Development for NCEs

For New Chemical Entities (NCEs), formulation development ensures that promising molecules can transition from discovery to clinical evaluation efficiently and reliably.

Key Offerings:

  • Pre-formulation Studies:
  • Solid-state characterization
  • Solubility screening
  • Excipient compatibility studies
    • Prototype Development for First-in-Human (FIH) Studies
    • Parenteral, Oral, Topical, Inhalation Formulation Development
    • Scale-up, Tech Transfer & GMP Manufacturing

Sterile Fill-Finish Capabilities

3. Formulation Development for Generics

 We provide turnkey formulation development for generic versions of leading drugs with an emphasis on quality, regulatory compliance, and cost-efficiency.

Key Offerings:

  • Complex Generics Development:
  • Liposomal formulations
  • Depot injections
  • Nasal sprays, inhalation products
  • Ophthalmic preparations
    • BE/PK Study Support
    • Regulatory Filing Support (ANDA, DMF)
    • Global Scale Manufacturing with Tech Transfer

4. Analytical & Regulatory Support

  • Analytical method development & validation
  • Stability studies (ICH guidelines)
  • Regulatory dossier preparation (IND, NDA, ANDA, EMA)

Why Partner with Us?

  • Proven track record with global pharmaceutical leaders
  • Access to advanced drug delivery technologies
  • Expertise in global regulatory frameworks
  • Integrated API to FDF (Finished Dosage Form) solutions (like Piramal’s integrated model)
  • Flexible engagement models (fee-for-service, FTE-based, risk-sharing)