A Breakdown of Dapagliflozin API Pricing: What Influences the Cost per Kg?

A Breakdown of Dapagliflozin API Pricing: What Influences the Cost per Kg?

Dapagliflozin API, a high-demand SGLT2 inhibitor for diabetes and chronic kidney disease, faces growing global demand. Key pricing factors include raw material sourcing, synthesis complexity, regulatory compliance, and scale of production. Hyderabad-based pharma manufacturers—like WHO-GMP-certified Bio-Synth—leverage economies of scale, industrial infrastructure, and process innovation to deliver cost-effective, high-purity APIs. This article breaks down the cost structure, production routes, and strategic sourcing insights essential for B2B buyers, API procurement teams, and CDMO planners.

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Why is Dapagliflozin API in High Demand Globally?

Therapeutic Use Beyond Diabetes

Dapagliflozin, marketed globally under generic and branded names, was originally developed for Type 2 diabetes mellitus. However, its FDA and EMA-approved indications now include:

• Heart failure with reduced ejection fraction (HFrEF)
• Chronic kidney disease (CKD)
• Cardiovascular risk reduction in diabetic patients

This expanding therapeutic scope has significantly increased year-on-year API demand. Learn more about where Dapagliflozin fits across types of APIs: small molecules, peptides, and biologics.

Market Projections

According to market forecasts:

• The global diabetic population is expected to reach 643 million by 2030.
• Dapagliflozin is now part of essential drug lists in Asia, Latin America, and MENA.
• Generic launches across Europe and North America post-patent expiry have fueled procurement growth.

 

Key Dapagliflozin API Pricing Factors for Manufacturers

Pricing depends on several interrelated technical, operational, and regulatory variables. For a process-level view, see our API manufacturing process overview.

1) Raw Material Costs and Supplier Sourcing

• High-purity glycosyl building blocks like chloropropyl glucopyranose represent significant input costs.
• Specialty reagents used in glycosylation and deprotection steps add to the per-batch expenditure.
• Fluctuating prices of acetonitrile, DMF, and other solvents affect operating overhead.

India, especially Telangana and Gujarat, offers secure supply lines and competitive sourcing from localized API and intermediate clusters.

Raw Material	Role in Synthesis	Cost Impact Level
3,4-Dihydroxybenzoic acid	Aromatic moiety precursor	Medium
Chloropropyl glucose	Sugar unit for the glycosylation step	High
NaH / K₂CO₃	Base for coupling reactions	Medium
DMF / MeOH	Solvents in various stages	High (volatile)

Tip: India’s Make-in-India and API PLI schemes reduce import dependence for critical intermediates. Explore our range of advanced drug intermediates.

 

2) Multi-Step Complex Synthesis

Dapagliflozin synthesis involves several high-precision steps:

Typical Synthesis Route:

1. Glycosylation Reaction: Coupling protected glucose with aromatic aglycone
2. Deprotection: Removal of benzyl groups
3. Salt Formation (if applicable): For better bioavailability or stability
4. Crystallization & Micronization: Controlled PSD requirements

This process requires tight control of temperature, pH, air exposure, and stereoselectivity—all of which add to the CapEx/Opex balance.

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3) Regulatory Compliance: WHO-GMP to US FDA Readiness

Regulatory Bodies Involved:

• CDSCO (India)
• US FDA
• EMA (EU)
• PMDA (Japan)

Each region requires:

• Drug Master File (DMF) submissions
• Impurity profiling using advanced analytics (HPLC, LC-MS)
• Data on polymorphs, residual solvents, and process validation
• Cleanroom setup compliant with ISO Class 7–8

Manufacturers in Hyderabad’s Balanagar Industrial Area are well-positioned for compliance due to state-supported pharma infrastructure. For product specifics, see our dedicated page on Dapagliflozin API manufacturers & suppliers in India.

4) Plant Infrastructure and Technology

Production Scale	Key Features	Cost Efficiency
Small (5–10 kg)	R&D/clinical batches	Low
Mid-scale	Domestic or regional contracts	Moderate
Large-scale (tons/year)	Export-oriented; fully automated	High

Hyderabad-based facilities like Bio-Synth use glass-lined reactors, HVAC systems, and solvent recovery units to reduce per-kg cost and environmental burden.

 

Dapagliflozin Manufacturing Cost Breakdown

High-level snapshot of the production cost structure:

Cost Element	Contribution to Total Cost
Raw Materials	~40%
Solvents & Reagents	~15%
Utility & Power	~10%
QA/QC & Testing	~7%
Regulatory & Licensing	~5%
Labor	~8%
Overhead & Logistics	~15%

Energy recovery systems, solvent recycling, and ZLD units are important for sustainable operations and long-term cost control.

 

Green Chemistry and Innovation in Indian API Manufacturing

Bio-Synth and other WHO-GMP-certified suppliers are shifting towards eco-friendly APIs by investing in:

• Low-solvent synthesis alternatives
• Microwave-assisted synthesis
• Green solvents (e.g., EtOAc, water-phase reactions)
• On-site effluent treatment & solvent distillation

Result: Reduction in E-factor (mass of waste/mass of product) from >100 to <40 in some plants.

 

Strategic Advantages of Indian Dapagliflozin API Suppliers

Local Context: Hyderabad’s Industrial Edge

• Clusters like Balanagar, Jeedimetla, and Pharma City (Hyderabad) enhance raw material availability.
• Telangana promotes CDMOs via tax incentives and priority clearances.
• Skilled talent pool in pharma, chemistry, and compliance adds value to every batch.

Export-Oriented API Ecosystem

• India is the third-largest API manufacturer globally.
• WHO-GMP, CEP, and DMF-ready suppliers ease global procurement.
• Indian companies offer transparent pricing, robust QA/QC, and faster lead times.

For a deeper dive into process stages, bookmark our API manufacturing process overview.

 

FAQs

1)Why do B2B buyers prefer Indian Dapagliflozin API manufacturers?

India offers cost-efficient, regulatory-compliant APIs with proven export quality. Manufacturers like Bio-Synth provide WHO-GMP-certified Dapagliflozin, backed by robust testing, scale, and documentation.

 

2) How does synthesis complexity affect Dapagliflozin API pricing?

Each synthetic step adds handling costs, material consumption, and quality control burdens. Complex glycosylation and deprotection reactions make Dapagliflozin more expensive than simpler anti-diabetic APIs.

 

3)What compliance documents are required for importing Dapagliflozin API?

Buyers typically need:

• Drug Master File (open/closed part)
• GMP compliance certificate
• Impurity profile & CoAs
• Stability data under ICH guidelines

 

Final Thoughts

Dapagliflozin remains a game-changing molecule in the treatment of diabetes, heart failure, and CKD. However, delivering affordable, high-purity APIs to the global market requires:

• Strategic raw material procurement
• Efficient synthesis with environmental safeguards
• Investment in compliance, cleanroom infrastructure, and documentation

By leveraging India’s pharma export ecosystem—especially in Hyderabad—buyers can access robust, regulation-ready Dapagliflozin API with confidence.

📩 Ready to discuss pricing, DMF support, or CDMO scope? Contact Bio-Synth today.