GMP Certification
Every molecule in the TadbeerPharma pipeline is manufactured by a facility holding a current WHO-GMP certificate. This is a non-negotiable requirement for AFDA registration and for our own quality standards.
Certified Manufacturing Regions
Dhaka-based API and finished-dose manufacturers with WHO-GMP certification and USFDA Drug Master Files on record.
Hyderabad and Ahmedabad facilities certified to Schedule M (revised) and WHO-GMP. Preferred for oncology generics and antivirals.
EMA-recognised manufacturing sites supplying high-quality finished-dose forms to 60+ countries, with full WHO-GMP compliance.
Standards We Operate To
World Health Organization Good Manufacturing Practice guidelines — the baseline standard for all partner facilities.
International Council for Harmonisation pharmaceutical quality system standard, covering lifecycle management.
Quality management system certification ensuring consistent processes and continuous improvement.
All manufacturing sites must hold valid GMP certificates recognised by the Afghan Food and Drug Authority.
GMP as a Registration Prerequisite
The Afghan Food and Drug Authority mandates a valid WHO-GMP certificate from the manufacturing site as part of the registration dossier. We select and vet manufacturing partners before molecular analysis begins, ensuring no pipeline candidate is delayed by a compliance gap at the manufacturing stage.