Clinical Batch Supply

API Manufacturing >> Clinical Supply >> Overview

PMC ISOCHEM offers cGMP and non cGMP industrial exclusive custom synthesis and provides tailor made services from development to production, including route selection, process and analytical development as well as process optimization.

Kilo Lab for Your Clinical API Demand in Kilo Scale

API Manufacturing >> Clinical Supply >> Overview

Our kilo lab allows us to conveniently bridge the gap between lab and pilot scale.

Peptide & Small Molecules APIs

API Manufacturing >> Clinical Supply >> Overview

Each year, Bachem manufactures hundreds of batches of drug substance for projects in clinical trials and for products on the market.

Manufacture for Late Stage Clinical Supply

API Manufacturing >> Clinical Supply >> Overview

Dishman Custom Services, comprising both the CARBOGEN AMCIS and Dishman CRAMS businesses, offer solution to all of their active pharmaceutical ingredient requirements, having an ability to manage projects from preclinical through to commercial scale manufacture.

Clinical Phases to Recurrent Production

API Manufacturing >> Clinical Supply >> Overview

Diverchim has several equipped laboratories with one fully dedicated to cGMP production (clinical phases and recurrent production) for tens of grams.

cGMP Manufacturing of API for Clinical Trials

API Manufacturing >> Clinical Supply >> Overview

KriSan Biotech has cGMP manufacturing of API for clinical trials (few grams to kilograms scale)

Clinical Supply

API Manufacturing >> Clinical Supply >> Overview

Our custom synthesis business integrates completely all the phases of chemical development: design of a novel synthetic pathway accompanied by supply of a few grams, provision of pilot batches following development of the industrial procedure.

Late Stage Clinical (Phase 2 and Phase 3) for New Drugs

API Manufacturing >> Clinical Supply >> Overview

Chemspec Exclusive Synthesisfor Pharma Chemicals focuses on a spectrum of early clinical to commercial services that are aligned with the long-term needs of pharmas and biotechs for small molecule projects.

End to End Process for Late Phase & Commercial Supply

API Manufacturing >> Clinical Supply >> Overview

Dishman facilities operate to current Good Manufacturing Practice (cGMP) and can produce material for preclinical testing, clinical trials and commercial use. Our manufacturing sites are regularly inspected by the US Food and/or Drug Administration (FDA) and local regulatory bodies.

Clinical Supply

API Manufacturing >> Clinical Supply >> Overview

We have deep experience in helping our clients move forward from the discovery phase of product development to the scale up of New Chemical Entities for clinical supply.