To source GMP-grade ketanserin for a clinical trial, you'll need to work with a certified manufacturer or supplier who can provide:

GMP (Good Manufacturing Practice) compliance certificates

Certificate of Analysis (CoA)

Drug Master File (DMF), if required

Batch records and documentation suitable for regulatory submission

Here are immediate steps you can take:

1. Contact Specialized GMP Suppliers

Look for companies specializing in GMP-grade APIs for clinical trials. Some known suppliers include:

Sigma-Aldrich / MilliporeSigma

CordenPharma

CARBOGEN AMCIS

Almac Group

Porton Pharma Solutions

PharmAgra Labs

2. Use Sourcing Platforms

Search for GMP ketanserin on:

PharmaCompass (www.pharmacompass.com)

ChemSpider or MolPort

Alibaba (filter for GMP-certified suppliers)

CDMO or CRO directories

3. Regulatory & Logistics

Ensure:

The material is GMP-certified for human use

The supplier can ship to your trial location with full documentation

You consult your regulatory team or ethics committee before procurement

All the best 👍

Hello Hezam,

thank you very much for your detailed reply. I will be in touch if I have any questions

All the best,

Antonio

You can find instructions on the EMA website by following this link:

https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice