Dapagliflozin Specification Sheet: Key Details for API Procurement Teams
Dapagliflozin Specification Sheet: Key Details for API Procurement Teams
This blog outlines the complete Dapagliflozin specification sheet ideal for B2B pharma procurement teams, formulators, and contract developers. Learn about its chemical properties, regulatory compliance, storage guidelines, and sourcing opportunities.
With rising global demand for anti-diabetic drugs, Indian API manufacturers, especially those in Hyderabad’s pharma clusters, are preferred suppliers due to cost-effectiveness and WHO-GMP standards.
Bio-Synth, a leading Dapagliflozin API manufacturer in India, delivers consistent quality for global buyers.
Understanding Dapagliflozin: A High-Demand Diabetes API
What is Dapagliflozin?
Dapagliflozin is an SGLT2 inhibitor indicated for managing Type 2 diabetes mellitus. It lowers glucose by promoting urinary glucose excretion without affecting insulin secretion.
| Attribute | Details |
| INN | Dapagliflozin |
| CAS Number | 461432-26-8 |
| Molecular Formula | C21H25ClO6 |
| Molecular Weight | 408.87 g/mol |
| Category | Anti-diabetic, SGLT2 Inhibitor |
Global demand is increasing due to lifestyle diseases and newer approvals for heart failure and chronic kidney disease (CKD).
Dapagliflozin’s Role in the Global Pharmaceutical Market
- Part of the growing anti-diabetic drug segment projected at USD 85+ billion by 2028.
- Buyers source APIs from India’s hubs, especially Hyderabad, due to WHO-GMP compliance and CEP certifications.
Complete Dapagliflozin Specification Sheet
| Parameter | Specifications |
| Appearance | White/off-white crystalline powder |
| Identification | IR, HPLC, Mass Spectrometry |
| Assay (on dried basis) | 98.0% – 102.0% |
| Water Content | NMT 1.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| Related Substances | Total impurities NMT 1.0% |
| Optical Rotation | As per EP/USP |
| Specific Tests | SGLT2 inhibition assay, chiral purity |
| Storage | Store <25°C, protect from light/moisture |
| Shelf Life | 36 months |
| Packaging | HDPE/Aluminum drums with double LDPE liners |
| Documentation | DMF (Open/Closed), WHO-GMP, CEP/IPEC compliant |
🔍 Explore Bio-Synth’s API catalog for high-purity, GMP-compliant pharmaceutical ingredients.
The Strategic Importance of Hyderabad in API Manufacturing
Why Hyderabad Leads India’s API Ecosystem
Bio-Synth operates in Hyderabad’s pharma clusters, including Balanagar Industrial Estate and Genome Valley.
Hyderabad strengths:
- Proximity to logistics hubs
- PLI government schemes
- WHO-GMP & EU-GMP plants
- Skilled workforce & CDMO ecosystem
In Numbers:
- 30–35% of India’s bulk drug production
- 200+ API & intermediate manufacturers
- Exports to 100+ countries (FY2023)
Ensuring Compliance: WHO-GMP and Regulatory Readiness
What Makes a Manufacturer WHO-GMP Compliant?
- Dedicated cleanrooms per API class
- Regular audits & documentation
- Full traceability & impurity profiling
- Environmental & water monitoring
Bio-Synth supports buyers with:
- Open & Closed DMFs
- ICH Q1A stability data
- CEP/IPEC impurity profiling
- Retention samples & batch consistency data
Learn more about API manufacturing processes.
Sourcing Dapagliflozin: Key Procurement Considerations
Checklist for Buyers:
- Verify WHO-GMP, CEP, ISO certifications
- Request CoA per batch
- Assess impurity & chiral purity data
- Review DMF / evaluation pack
- Audit QMS protocols
- Confirm packaging & stability
Why Bio-Synth Stands Out:
- 80+ years of experience (since 1943)
- Rapid RFQ & sample turnaround
- R&D + analytical support
- Flexi-volume production (R&D to bulk)
- Custom CDMO solutions
Bio-Synth’s Anti-Diabetic & Cardiovascular APIs
In addition to Dapagliflozin, Bio-Synth manufactures:
- Empagliflozin
- Linagliptin
- Carvedilol
- Resmetirom
Each API follows strict traceability & WHO-GMP standards.
CDMO and Bulk Supply Services
Bio-Synth CDMO Capabilities:
- Route scouting & impurity clearance
- Chiral synthesis & scale-up
- Technology transfer & validation
- CTD/ACTD dossier support
Also explore: pharmaceutical intermediates.
FAQs
- Why do buyers trust Indian APIs for Dapagliflozin?
India offers cost-effective, high-quality, WHO-GMP APIs. Bio-Synth’s compliance makes it globally trusted. - How do I verify Dapagliflozin specifications?
Ask for CoA, DMF access, and specification sheet , covering assay values, impurities, and compliance. - Can Bio-Synth support CDMO/custom formulations?
Yes , from route design to clinical batches, Bio-Synth provides full CDMO support.
Final Thoughts
Demand for Dapagliflozin API is expanding. Sourcing from WHO-GMP Indian manufacturers like Bio-Synth ensures compliance, cost-efficiency, and supply security.
📩 Contact Bio-Synth today for bulk quotes, regulatory documentation, and CDMO collaboration.
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