WHO-GMP
World Health Organization — Good Manufacturing Practice
Compliance
Regulatory Compliance & Certifications
Every API we export is backed by verified manufacturer certifications, pharmacopoeia-grade quality, and complete documentation.
All APIs exported by Novo Bharat Global Export are manufactured and sourced exclusively from facilities holding valid WHO-GMP, USFDA, or EU-GMP certifications at the time of export.
We maintain a complete documentation trail for every shipment — available for regulatory audits, import clearance, and buyer due-diligence requirements.
Verified Sources
Manufacturer Certifications
USFDA
US Food & Drug Administration — Manufacturer Approved
EU-GMP
European Union Good Manufacturing Practice
TAG
European Union Good Manufacturing Practice
COFA / ISP
Chile ANAMED — Regulatory Approval
ISO 9001:2015
Quality Management System
Pharmacopoeia
BP · USP · IP · EP · JP standards
REACH
European Chemicals Compliance
Export Compliance
Documents We Provide With Every Shipment
Complete, audit-ready documentation accompanies every consignment. Whether you are clearing customs in a regulated market or filing for product registration, our paperwork is prepared to meet international due-diligence requirements.
Country-specific documents and additional regulatory support can be arranged on request — just tell us your target market when you send your enquiry.
- Certificate of Analysis (COA)Batch-specific quality results
- Material Safety Data Sheet (MSDS/SDS)Safety & handling information
- Drug Master File (DMF)Regulatory filing document
- Certificate of Origin (COO)Country of manufacture
- Packing List & Commercial InvoiceExport documentation
- Shipping BillIndian customs document
- Re-test CertificateOn request, for shelf-life extension
- Pharmacopoeia Reference Standard CertificateConformance to pharmacopoeia grade