Glimepiride API supplier with DMF — complete buying guide for procurement teams
If you are procuring Glimepiride API for regulated or semi-regulated markets, selecting a supplier with a valid DMF is critical. This guide explains what to check, what to request, and how to reduce regulatory and quality risks.
1) What is Glimepiride API?
- Glimepiride is an oral antidiabetic drug used for type 2 diabetes.
- The API is the active substance used in finished dosage forms.
- Quality, impurity control, and regulatory documentation are essential.
2) What is a DMF and why it matters
A DMF (Drug Master File) is a confidential regulatory document filed by the manufacturer. It describes the API manufacturing process, facilities, controls, and quality systems.
- Enables faster regulatory review
- Improves traceability and compliance confidence
- Supports FDA, EMA, and other authority submissions
3) Key regulatory and quality rules buyers must know
- ICH Q3A / Q3B impurity limits and qualification rules
- GMP compliance and inspection history
- Type II DMF confirmation and regional applicability
4) Mandatory documents to request from suppliers
- Batch-specific Certificate of Analysis (CoA)
- DMF number and holder details
- GMP certificate and audit report
- Stability data and shelf life
- Analytical methods and validation reports
- Impurity profile aligned with ICH guidelines
- Supply chain traceability and raw material sources
- MSDS, packaging specification, and export documents
5) Technical specifications to verify in the CoA
- Assay by validated HPLC method
- Related substances and unidentified impurities
- Residual solvents as per ICH Q3C
- Heavy metals and moisture content
- Polymorphic form and particle size distribution
6) Step-by-step procurement checklist
- Initial supplier screening and document review
- Sample order and independent third-party testing
- Factory audit (on-site or virtual)
- Quality agreement and change control clauses
- Commercial terms, MOQ, lead time, incoterms
- DMF referencing during regulatory filing
7) Pricing, lead times and logistics
- Pricing depends on compliance level and capacity
- Typical lead time: 8–12 weeks
- Confirm moisture-proof packaging and transport conditions
8) Red flags — when to stop procurement
- Supplier refuses to provide DMF number or access
- No GMP certification or inspection history
- Incomplete or inconsistent CoA data
- Refusal of independent testing or audits
9) Final checklist before issuing a PO
- DMF confirmed and accessible to regulators
- CoA verified against third-party lab results
- GMP and audit documents validated
- Quality agreement signed
- Packing, storage, and shipping finalized
10) How Globaux supports procurement teams
Globaux helps buyers source Glimepiride API from verified suppliers with DMF support, quality documentation, and regulatory coordination.
Phone: +91 99044 98877 | +91 95580 12935 | +91 93131 88670
Email: mail@globaux.net