← All Industries
💊
Pharmaceutical Exports
India is the pharmacy of the world — the largest supplier of generic medicines globally. But pharmaceutical exports require precise documentation, cold chain handling, and regulatory compliance.
Documents typically required
- WHO-GMP Certificate (for regulated markets)
- CDSCO NOC (for scheduled substances)
- Certificate of Analysis (CoA)
- Certificate of Pharmaceutical Product (CoPP)
- GMP Certificate
- MSDS for APIs
- Temperature excursion report for cold chain
Common challenges
- Different regulatory approvals needed for each destination country
- Cold chain integrity must be documented from factory to airport
- DG classification for some APIs
- US FDA, EU EMA requirements for regulated market exports
Tips from our team
- Pre-qualify your product for target markets before the first shipment
- Use validated packaging for cold chain — insulated boxes with ice packs or dry ice
- Maintain chain of custody documentation for all pharma exports