Empagliflozin vs Dapagliflozin APIs: Key Differences Pharma Buyers Should Know
Empagliflozin vs Dapagliflozin APIs: Key Differences Pharma Buyers Should Know
Empagliflozin and Dapagliflozin APIs are leading sodium-glucose co-transporter-2 (SGLT2) inhibitors used in type 2 diabetes management. While both are effective in lowering blood glucose levels and improving cardiovascular outcomes, they differ in pharmacokinetics, safety profiles, and regulatory status. For pharma buyers, especially in procurement and formulation development, these differences can influence sourcing decisions. If you’re working with Indian API suppliers or looking for WHO-GMP-compliant CDMOs, understanding these nuances is key. Hyderabad, with its robust pharmaceutical ecosystem including Bio-Synth’s state-of-the-art facility in Balanagar, stands as a strategic hub for high-quality SGLT2 inhibitor APIs.
Understanding SGLT2 Inhibitor APIs
What are SGLT2 Inhibitors?
SGLT2 inhibitors are a class of antidiabetic drugs that reduce blood glucose by increasing urinary glucose excretion. Unlike insulin-based therapies, they do not rely on pancreatic function and offer cardiovascular and renal benefits.
API Use Case in Formulations
- Empagliflozin API and Dapagliflozin API are key actives in oral antidiabetic fixed-dose combinations.
- They are often paired with metformin or DPP-4 inhibitors and are marketed under well-known brands such as Jardiance® (Empagliflozin) and Farxiga® (Dapagliflozin).
Empagliflozin vs Dapagliflozin: Key API Differences
| Feature | Empagliflozin API | Dapagliflozin API |
| CAS Number | 864070-44-0 | 461432-26-8 |
| Molecular Weight | 450.91 g/mol | 408.88 g/mol |
| Bioavailability | ~78% | ~78% |
| Half-life (t₁⁄₂) | ~12 hours | ~12.9 hours |
| Primary Indication | Type 2 diabetes, heart failure | Type 2 diabetes, CKD, heart failure |
| Dosing Frequency | Once daily | Once daily |
| Glucose Reduction | Slightly Higher | Moderate |
| Renal Protection | Strong evidence | Strong evidence |
| Metabolism Pathway | Glucuronidation (UGT enzymes) | Glucuronidation (UGT1A9) |
| Market Launch | 2014 | 2012 |
While both APIs are similar in class, their metabolic profiles and clinical indications differ. Empagliflozin API Manufacturers in India focus on heart failure indications, whereas Dapagliflozin API Suppliers in India cater more to CKD-related formulations.
Why India is the Global Hub for SGLT2 APIs
Indian API Manufacturers Lead in Volume and Value
India supplies over 20% of the global generic drug exports. API hubs like Hyderabad and Vizag host hundreds of WHO-GMP- and USFDA-certified facilities, making India a key sourcing destination.
Hyderabad: The Nerve Center of API Excellence
Hyderabad, home to Balanagar Industrial Area, has emerged as the API capital of India. Bio-Synth’s Hyderabad facility is fully WHO-GMP compliant, providing APIs with full regulatory documentation and traceability.
Key Advantages for Global Buyers
- Competitive pricing due to economies of scale
- Regulatory compliance (CEP, USDMF, WHO-GMP)
- Strong IP support and documentation
- Fast turnaround for analytical validation and samples
🔍 Explore pharmaceutical intermediates and advanced drug intermediates to support your formulations.
Procurement Considerations: Which API Should You Choose?
- Target Indication and Formulation
- If the formulation targets diabetes with heart failure comorbidity, Empagliflozin API Suppliers in India may offer added value.
- If the indication leans toward kidney protection, especially in CKD settings, Dapagliflozin API Manufacturers might be preferred.
- Regulatory Filings and Approvals
Check for:- USDMF availability
- CEP registration (EMA)
- Japan DMF (J-DMF) filing
- Bio-Synth provides both Empagliflozin API Specification and Dapagliflozin API Specification with compliance-ready documentation.
- Purity and Residual Solvent Profile
Both compounds require stringent impurity profiling. Bio-Synth ensures:
- <0.05% residual solvents
- Impurity profiling per ICH Q3A/B
- Particle size 10–50 μm (micronized APIs optional)
- Shelf-Life and Stability
Empagliflozin and Dapagliflozin both require nitrogen-packed, low-moisture packaging.
Regulatory and Supply Chain Challenges
- DGFT notifications affect export licenses
- Pre-shipment testing required for ASEAN & China markets
- Export-ready documentation: COAs, stability data, TSE/BSE
Learn more in our API manufacturing process overview.
Trends in Global SGLT2 Market
- Global SGLT2 market projected to reach $12.4 billion by 2026
- India’s share in exports rising due to China+1 strategy
- Strong demand for Empagliflozin API Price in India and Dapagliflozin API Price in India
Strategic Insight From a Hyderabad-Based Manufacturer
Bio-Synth offers:
- Weekly production capacity: 600 kg+ Empagliflozin API Manufacturers; 600 kg+ Dapagliflozin API Suppliers
- WHO-GMP approved infrastructure
- Real-time batch tracking and audit readiness
FAQs
1)Why do buyers trust Indian APIs for diabetes drugs?
India offers cost-competitive APIs with world-class quality. WHO-GMP certified suppliers, such as Bio-Synth, deliver regulated-market-ready Empagliflozin API and Dapagliflozin API in India, along with full documentation.
2)Can both Empagliflozin and Dapagliflozin be used in combo therapies?
Yes. They are often co-formulated with metformin, saxagliptin, or linagliptin.
3)Is there a significant cost difference between the two APIs?
Yes. The dapagliflozin API Price is usually lower due to fewer synthesis steps; however, the empagliflozin API Price in India may fetch a premium reimbursement.
Ready to source high-purity APIs with full compliance?
Partner with Bio-Synth today for regulatory-ready Empagliflozin and Dapagliflozin bulk supply.
Contact Bio-Synth for quotes and documentation.
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