Glimepiride API manufacturer in India — complete buyer’s guide
If you are sourcing Glimepiride API in bulk, choosing the right manufacturer is critical. This guide helps buyers, procurement managers, and importers understand quality requirements, regulatory documents, pricing expectations, and supplier evaluation.
1) What is Glimepiride API?
- Glimepiride is a sulfonylurea antidiabetic drug used to control blood sugar in type 2 diabetes.
- As an API, it must meet pharmacopeial specifications such as USP or IP.
- Strict control of assay, impurities, and stability is mandatory.
2) Why buy Glimepiride API from India?
India is one of the largest global producers of pharmaceutical APIs. Indian manufacturers offer GMP-compliant production, competitive pricing, and experience supplying regulated and semi-regulated markets worldwide.
3) Key technical specifications buyers must verify
- Certificate of Analysis (CoA) referencing USP or IP monograph
- Assay and impurity profile within pharmacopeial limits
- Residual solvent testing as per ICH Q3C
- Heavy metals and microbial limits (if applicable)
- Stability data and declared shelf life
4) Regulatory documents required from manufacturers
- Valid GMP certificate or audit report
- DMF or CEP availability for product registration
- MSDS / SDS and packaging details
- Export documentation support if applicable
5) How to shortlist and audit a Glimepiride API manufacturer
- Shortlist suppliers with GMP certification and export history
- Review CoA and DMF/CEP details
- Request samples and conduct third-party lab testing
- Perform virtual or on-site factory audits
- Confirm supply consistency and backup raw material sources
6) Pricing, MOQ and logistics
- Prices vary based on order size, quality grade, and market conditions
- MOQ typically starts from 10–25 kg or one full drum
- Confirm INCOTERMS, lead time, freight, and insurance
7) Packaging, storage and shelf life
- Usually packed in HDPE or fiber drums with inner liners
- Store in a cool, dry place away from moisture and light
- Shelf life commonly ranges between 24–36 months
8) Common red flags buyers should avoid
- Supplier refuses to share full CoA or GMP documents
- No DMF or regulatory support for exports
- Unrealistically low pricing without justification
- Mismatch between CoA and third-party lab results
9) Final checklist before placing a bulk order
- CoA verified against independent lab results
- GMP and DMF/CEP confirmed
- Packaging, shelf life, and batch release agreed
- Clear payment and quality dispute terms
10) Need assistance sourcing Glimepiride API?
We help buyers connect with reliable Indian Glimepiride API manufacturers, verify documentation, and coordinate quality checks.
Phone: +91 99044 98877 | +91 95580 12935 | +91 93131 88670
Email: mail@globaux.net