Utilize Our Expansive Range of Capabilities

3 FDA Inspected facilities manufacturing clinical and commercial programs

Wide range of capabilities from Kgs to hundreds of tons

Reactors ranging from 10L to 10,000L

HPAPI Capability to handle OEB 4, 5 and 6 compounds

Dedicated equipment trains for steroids

Niche capability including sterile crystallization and spray drying

Process Development and Optimization for Scale up of Drug Substance

6 Manufacturing Sites - 4 FDA Approved

Formulation development: Tablets, Capsules, and Oral Solutions

Pilot and small-scale clinical and commercial batches

High potent and conventional tablets and capsules (OEB 1 -6)

Large scale commercial manufacturing sites – Billions tablets/capsules per year

Commercial Packaging - Bottles and Blisters

Modalities: Small Molecules, Biologics, Peptides, ADCs, mRNA, non-viral vaccines

Injectable Drug Products: Vials, PFS, APIJECT, Ampoules. Powder (lyophilized), Liquids, Suspension

Ophthalmic Dosage Forms: Solutions, Emulsions, Suspensions, Gels, Creams, Ointments. Blow Fill Seal, 3 Piece Bottles, Multidose Bottles, Sterile Tubes, Novelia: Preservative-Free, Multidose Dropper

2 Manufacturing Sites in India - RSMs for clinical and commercial programs

Capability from grams to kilograms to tons

Rapid initial scale up from medicinal chemistry route to first kilograms

Pharma Expanse commissioned an audit of the facility as part of the supplier qualification process

Lead optimization, synthesis of NCE’s, focused libraries, building blocks and lead compounds

Route scouting and synthesis of analogues

Synthesis of reference standards, metabolites, impurities, and stable labeled compounds

Optimization and scale-up of existing processes

Developing new scalable and economically viable processes

Preclinical (non-GMP) manufacturing of API, Intermediates and RSMs