Why MedPharm for Generics?

Topical and Transdermal Focus

Unlike generalist CDMOs, we are deeply immersed in semisolid and transdermal formulations—making us the ideal partner for generic dermatology and mucosal drug products.

ANDA and Hybrid Filing Expertise

We support both traditional ANDAs and 505(b)(2) hybrid submissions for differentiated generics and reformulations.

Regulatory Alignment

Our services and study designs are built in accordance with FDA, EMA, and MHRA guidance, including product-specific guidances (PSGs) and IVRT/IVPT requirements.

Bioequivalence Without Clinical Trials

We specialize in alternative BE approaches using validated In Vitro Release Testing (IVRT) and In Vitro Permeation Testing (IVPT) to reduce the need for full clinical equivalence studies.

Proven Track Record

MedPharm has supported numerous successful global generic approvals, including corticosteroids, antifungals, antivirals, local anesthetics, and combination products.

Our Services for Generics

We provide comprehensive support for generic development, from early feasibility through submission and approval.

Formulation Development 

• Q1/Q2 formulation matching
• Prototype screening
• Excipients assessment and reverse engineering
• Microstructure, rheology, and particle size optimization

In Vitro Testing for Bioequivalence 

• IVRT and IVPT method development and validation
• Human skin permeation studies under GLP
• Acceptance criteria design and statistical analysis
• Tissue retention, protein binding, and disease state modeling

Analytical & Regulatory Support 

• Assay and impurity profiling
• Method validation (ICH Q2)
• Stability studies (accelerated & long-term)
• ANDA dossier preparation and FDA Q&A support
• Global regulatory consulting (EU hybrid, ROW filings)

Manufacturing Services 

• GMP clinical and registration batch manufacturing
• Scale-up and process optimization
• PPQ/validation batch support for submission
• Packaging, labeling, and clinical supply chain support

Accelerating Access with Smart Science

In the fast-moving world of generics, success depends on scientific rigor, efficient execution, and total regulatory clarity. MedPharm delivers all three—bringing your product to market faster, with fewer surprises and stronger support at every stage.