Bangladesh's pharmaceutical industry — exporting to 150+ countries and recently allowed US FDA-approved drug manufacturing — is one of South Asia's most significant. For pharmaceutical companies, ISO 9001 aligned with DGDA (Directorate General of Drug Administration) requirements and WHO GMP certification is the quality management pathway for export market qualification.
$500M+
Bangladesh pharma exports
DGDA
Drug regulatory authority
150+
Countries Bangladesh exports to
BDT 15K
Starting cost
Bangladesh Pharma — ISO Requirements
- DGDA manufacturing license — ISO 9001 strengthens DGDA manufacturing license applications
- Export to Africa — African national medicines authorities require WHO GMP certificate (from DGDA) + ISO 9001
- Export to Myanmar, Sri Lanka, Nepal — Regulatory authorities require ISO 9001 from importers
- Institutional buyers (UNICEF, WHO) — WHO prequalification requires ISO 9001 as quality management foundation
Get ISO Certified in Bangladesh Today!
IAF CertSearch verifiable · Bangladesh Accreditation Board (BAB) aligned · From BDT 15,000 · Fully online
Frequently Asked Questions
ISO 9001 provides a documented quality management system that DGDA inspectors evaluate during manufacturing license review. It doesn't replace Schedule-C (pharmaceutical GMP) compliance but significantly strengthens the quality management evidence supporting DGDA applications.
For export to Sub-Saharan Africa: DGDA-issued WHO GMP certificate (primary requirement) + ISO 9001. Some African countries (Nigeria NAFDAC, Kenya PPB) have specific additional registration requirements. ISO 9001 from an IAF-accredited CB is the universal quality management credential.