2025 Global Trends in Empagliflozin API Manufacturing

Empagliflozin API: 2026 Market Trends, Patent Expiry & Technical Outlook

Key Takeaway

• API Name: Empagliflozin (SGLT2 Inhibitor).
• CAS Number: 864070-44-0.
• 2025 Outlook: Demand surging due to new indications (Heart Failure/CKD) and patent cliffs opening generic access.
• Key Sourcing Risk: Managing polymorphic forms (Amorphous vs. Crystalline) to avoid IP infringement.
• Primary Supply Hub: Hyderabad, India (Bio-Synth).

As we move through 2026, Empagliflozin API has evolved from a niche diabetes treatment to a cornerstone therapy for Cardio-Renal-Metabolic (CRM) disorders. For generic pharmaceutical companies, this represents a massive opportunity—but also a complex regulatory challenge.

With the expiration of key patents regarding the compound and its crystalline forms, the market is flooded with new demand. However, sourcing high-quality Empagliflozin requires navigating strict impurity profiles and polymorph stability. This guide explores the global manufacturing trends and procurement strategies for this vital SGLT2 inhibitor.

The 2026 Market Landscape: Beyond Diabetes

The global demand for Empagliflozin is no longer driven solely by Type 2 Diabetes. The label expansion for Heart Failure (HFrEF & HFpEF) and Chronic Kidney Disease (CKD) has significantly increased the volume requirements for the API.

Key Market Shifts:

1. The Patent Cliff: As exclusivity periods end in major markets (US/EU), generic manufacturers are racing to file ANDAs.
2. Combination Therapies: There is a sharp rise in demand for Fixed-Dose Combinations (FDCs), specifically Empagliflozin + Metformin and Empagliflozin + Linagliptin. Sourcing an API compatible with these co-formulations is critical.

Technical Specifications & Sourcing Data

For R&D teams, the “Commercial Grade” is defined by specific technical parameters.

Manufacturing Challenges: Polymorphs & Purity

Why is Empagliflozin difficult to manufacture?

Sourcing from a WHO-GMP certified facility like Bio-Synth (Hyderabad) helps mitigate three specific risks:

1. Polymorphic Stability (IP Risk)

Innovator patents often cover specific crystalline forms. Generic manufacturers frequently require the Amorphous Form or specific polymorphs to bypass these patents. The supplier must guarantee that the API will not convert (recrystallize) during stability testing.

2. Stereochemistry (Chirality)

Empagliflozin is a C-glucoside with a complex structure involving multiple chiral centers. High-end process chemistry is required to maintain stereochemical purity and prevent the formation of isomeric impurities.

3. Nitrosamine & Genotoxic Impurities

Given the complex synthesis involving various solvents and reagents, a rigorous Nitrosamine Risk Assessment is mandatory for FDA and EMA compliance in 2025.

Why India (and Hyderabad) Leads the Supply Chain

India currently accounts for a significant share of the global generic SGLT2 supply. Hyderabad, specifically the Balanagar industrial corridors, has emerged as the nexus for this chemistry.

The Hyderabad Advantage:

• Integrated Ecosystem: Proximity to manufacturers of Key Starting Materials (KSMs) like D-Gluconolactone.
• Cost Efficiency: Advanced flow chemistry techniques adopted by Indian CDMOs have reduced the cost of goods sold (COGS) for this molecule.
• Regulatory Track Record: High density of USFDA-inspected facilities.

Procurement Checklist for 2025

Don’t just look at the Empagliflozin API price per kg. Use this checklist to validate your Empagliflozin supplier:

• Patent Non-Infringement: Does the supplier offer a non-infringing polymorph (e.g., Amorphous)?
• Particle Size Distribution (PSD): Can they micronize the API to meet your dissolution profile?
• FDC Readiness: Is the API grade suitable for wet granulation with Metformin?
• Regulatory Filing: Is the DMF/CEP active and available for reference?

Conclusion: Partnering for Generic Success

The “Gliflozin” era is here. To capture market share in the generic segment, pharmaceutical companies need an API partner who offers not just capacity, but technical defense—against patent infringement, impurity risks, and supply chain disruptions.

Bio-Synth, with over 80 years of chemical expertise in Hyderabad, is positioned to support your filings with high-purity, compliant Empagliflozin API.

Ready to Discuss Commercial Requirements?

This guide covered the market trends and technical risks.

As 2026 unfolds, Empagliflozin API demand is expanding beyond diabetes into CKD and cardiovascular markets. Patent expiry and generics will lower prices but increase volumes, creating opportunities for buyers.

India, and particularly Hyderabad, is set to lead global supply, with Bio-Synth delivering WHO-GMP certified APIs, regulatory support, and proven export expertise.

Start your sourcing journey today: Contact Bio-Synth

FAQs

Q1. What is the CAS number for Empagliflozin API?

The CAS number for Empagliflozin is 864070-44-0.

Q2. What are the major challenges in manufacturing Empagliflozin API?

The primary challenges are polymorphism control (ensuring the API stays in the desired Amorphous or Crystalline form to avoid patent infringement) and managing stereochemistry to prevent isomeric impurities.

Q3. Why is demand for Empagliflozin API increasing in 2026?

Demand is surging due to two factors: the expiration of innovator patents allowing generic entry, and the expanded therapeutic use of Empagliflozin for Heart Failure and Chronic Kidney Disease (CKD), which significantly increases patient volume.

Q4. Can Indian manufacturers supply Empagliflozin for regulated markets?

Yes. Indian manufacturers, particularly in the Hyderabad cluster (like Bio-Synth), are capable of supplying USFDA and EMA-compliant API, supported by active DMFs (Drug Master Files) and rigorous Nitrosamine Risk Assessments.