What is Empagliflozin API? Uses, CAS No, and Applications in Diabetes Treatment
Empagliflozin API: Uses, CAS No & Diabetes Drug Applications
Empagliflozin API is a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor, widely used in the treatment of type 2 diabetes mellitus. Identified by CAS No. 864070-44-0, it promotes glucose excretion via urine and supports cardiovascular and renal health. With demand growing globally, India especially Hyderabad has become a key hub for WHO-GMP compliant Empagliflozin API suppliers. This article explores its therapeutic role, specifications, and sourcing advantages for pharmaceutical buyers.
Learn more: Empagliflozin API Manufacturers & Suppliers in India
What is Empagliflozin API?
- Therapeutic Class: SGLT2 inhibitor (oral antidiabetic drug)
- CAS Number: 864070-44-0
- Molecular Formula: C23H27ClO7
- Form: White to off-white crystalline powder
Empagliflozin lowers blood sugar levels by blocking SGLT2 proteins in the kidneys, thereby preventing glucose reabsorption. Unlike many diabetes drugs, its mechanism is insulin-independent, offering metabolic advantages for overweight patients.
Therapeutic Benefits
- Improved Glycemic Control: Reduces HbA1c effectively.
- Weight Reduction: Supports modest weight loss.
- Cardiovascular Protection: Lowers risk of cardiovascular death.
- Renal Outcomes: Slows progression of diabetic kidney disease.
These multiple benefits make Empagliflozin one of the most preferred APIs for global pharmaceutical companies.
Mechanism of Action
SGLT2 proteins reabsorb nearly 90% of glucose from urine into the bloodstream. By inhibiting these proteins, Empagliflozin ensures:
- Increased urinary glucose excretion
- Lower plasma glucose concentration
- Reduced blood pressure and body weight
Its ability to work independently of insulin allows physicians to use it as monotherapy or in combination with metformin and DPP-4 inhibitors.
Clinical Applications
Pharmaceutical formulations containing Empagliflozin API are prescribed to:
- Treat type 2 diabetes as single or combination therapy
- Reduce risk of heart failure in diabetic patients with cardiovascular disease
- Improve outcomes in chronic kidney disease (CKD) patients
Global Demand & Market Growth
The SGLT2 inhibitor market has shown double-digit growth, driven by:
- Rising global incidence of diabetes
- Wider adoption of combination therapies
- Regulatory approvals for expanded indications
Empagliflozin APIs are in high demand across regulated markets like the US, EU, and Japan, making compliant supply crucial.
For broader trends, see: API Manufacturing Trends in India 2025.
India’s Advantage in Empagliflozin API Manufacturing
India, and particularly Hyderabad, has emerged as a powerhouse for API production thanks to:
- WHO-GMP, USFDA, and DCGI-approved facilities
- Cost-effective yet high-quality synthesis
- Well-developed CDMO infrastructure
- Strong B2B export network to regulated and semi-regulated markets
Partner with Bio-Synth: Empagliflozin API Manufacturers & Suppliers in India
Technical Specifications of Empagliflozin API
| Parameter | Specification Range |
| CAS Number | 864070-44-0 |
| Appearance | White to off-white crystalline powder |
| Assay (HPLC) | ≥ 98.5% |
| Related Substances | ≤ 0.5% (total impurities) |
| Residual Solvents | Within ICH Q3C limits |
| Heavy Metals | ≤ 10 ppm |
| Microbial Limits | Pharmacopeial compliance |
| Documentation | DMF, CoA, MOA, GMP, TSE/BSE, Stability |
Regulatory & Safety Profile
- Regulatory Approvals: USFDA, EMA, DCGI, and WHO list Empagliflozin as an essential oral antidiabetic.
- Documentation Support: Suppliers like Bio-Synth provide eCTD dossiers, process validation, and Zone IVb stability data.
- Safety Precautions: Proper PPE, containment systems, and compliance with OSHA and REACH guidelines are necessary during handling.
For more compliance insights, see: API Regulations and Standards.
Buyer’s Checklist for Empagliflozin API
| Factor | Why It Matters |
| WHO-GMP Certification | Essential for export formulations |
| DMF Availability | Required for regulatory filings |
| Batch Consistency | Ensures predictable formulation results |
| Scale-Up Support | Smooth transition from lab to production |
| Custom Specs | Tailored impurity or particle profile |
Why Choose Bio-Synth?
Based in Hyderabad’s Balanagar Industrial Area, Bio-Synth offers:
- 80+ APIs across therapeutic segments
- Strong SGLT2 portfolio (Empagliflozin, Dapagliflozin, Canagliflozin)
- WHO-GMP certified facilities and CDMO capabilities
- Regulatory and technical support for global clients
Contact Bio-Synth for bulk inquiries, COA requests, or collaboration opportunities.
Future Outlook for Empagliflozin & SGLT2 APIs
- Combination Therapies: Increasing use with Metformin, Linagliptin, and Dapagliflozin.
- Expanded Indications: Beyond diabetes, trials show benefits in heart failure and CKD.
- Indian Leadership: With enhanced R&D, digital traceability, and scale-up facilities, India will remain a global leader in SGLT2 APIs.
FAQs
- Why do buyers prefer Indian Empagliflozin API suppliers?
Because Indian manufacturers provide cost-effective, WHO-GMP compliant APIs with complete documentation, making them ideal for regulated markets. - What makes Empagliflozin unique compared to other diabetes drugs?
It works independently of insulin, reducing blood sugar while supporting cardiovascular and renal health. - How can I verify Empagliflozin API quality before purchase?
Check for DMF, GMP certification, and batch-specific COA. Request impurity profiling and ICH stability data for full assurance.
Conclusion
Empagliflozin API is transforming diabetes management by offering glycemic, cardiovascular, and renal benefits. With its rising demand, sourcing from India’s WHO-GMP certified suppliers like Bio-Synth ensures regulatory compliance, quality, and reliable global supply.
Explore: Empagliflozin API Manufacturers & Suppliers in India
Reach out: Contact Bio-Synth to request a quotation or technical package.
Post a comment