Dapagliflozin Quality Parameters: Why Global Buyers Trust Indian API Manufacturers Like Bio-Synth

Dapagliflozin Quality Parameters: Why Global Buyers Trust Indian API Manufacturers Like Bio-Synth

Dapagliflozin Propanediol Monohydrate API is a key compound for type 2 diabetes therapies around the globe. Its quality dramatically impacts drug safety, efficacy, and regulatory approvals. Indian pharmaceutical companies, especially Bio-Synth in Hyderabad, are emerging leaders in supplying high-purity, GMP-certified Dapagliflozin APIs.

As a WHO-GMP compliant manufacturer founded in 1943 and based in the Balanagar Industrial Area, Bio-Synth ensures unmatched consistency, regulatory support, and sustainable production. This article explores critical quality parameters, manufacturing best practices, and why Bio-Synth is a preferred partner for international pharmaceutical brands.

 

Understanding Dapagliflozin Propanediol and Its API Applications

What is it used for?

Dapagliflozin Propanediol Monohydrate is a selective Sodium-Glucose Cotransporter-2 (SGLT2) inhibitor. It plays a crucial role in:

• Managing blood glucose in Type 2 Diabetes Mellitus
• Offering cardiovascular protection
• Delaying progression of chronic kidney disease

It is widely used in monotherapy or fixed-dose combinations (FDCs) with metformin, sitagliptin, or empagliflozin. Learn more about types of APIs, including small molecules, peptides, and biologics.

 

Why is API quality so crucial?

The efficacy and safety of anti-diabetic drugs depend directly on the quality of the active ingredient. Inconsistent APIs lead to:

• Failed bioequivalence studies
• Regulatory rejections
• Market recalls

Hence, procurement professionals must scrutinize Dapagliflozin quality parameters before supplier selection. Explore our API manufacturing process overview for more insights.

 

Key Dapagliflozin Quality Parameters That Matter

Ensuring compliance and therapeutic performance starts with evaluating these critical API parameters:

 

Parameter	Industry Benchmark	Impact
Purity Level	≥99%	Ensures potency and minimizes adverse reactions
Crystalline Stability	Stable polymorph form	Guarantees consistent dissolution and absorption
Impurity Profile	<0.1% individual impurities	Protects patient safety and accelerates approvals
Residual Solvents	ICH Q3C compliant	Avoids toxicity due to manufacturing impurities
Batch Consistency	Low RSD (<2%)	Facilitates reproducibility in drug formulations
Regulatory Documentation	COA, MSDS, DMF	Speeds registration in global markets

 

➡️ These metrics also influence cost-per-tablet and regulatory overhead.

 

Why India Leads in Dapagliflozin API Production

India accounts for over 20% of global generic drug exports, making it a hub for API production. Here’s what sets Indian manufacturers apart:

• Vertical integration of starting materials and pharmaceutical intermediates
• Lower CapEx and OpEx, resulting in competitive pricing
• Robust regulatory infrastructure (WHO-GMP, USFDA, EU GMP certifications)
• Clusters like Hyderabad’s Genome Valley and Balanagar Industrial Area, centralizing pharma excellence

As a result, global buyers save time, reduce risk, and ensure supply continuity.

 

Bio-Synth: A Proven Dapagliflozin API Manufacturer in Hyderabad

Trusted Since 1943 — Our Legacy of Innovation

Headquartered in Hyderabad, Bio-Synth has built a reputation over eight decades by focusing on:

• GMP-certified facilities
• End-to-end API development
• Serving over 35 countries across regulated and semi-regulated markets

We specialize in small-to-large scale CDMO partnerships, B2B bulk manufacturing, and API supply for both innovators and generic drug players.

 

How Bio-Synth Ensures High-Quality Dapagliflozin APIs

1. Advanced & Scalable Manufacturing Facilities

Our Hyderabad plant integrates:

• Controlled temperature and humidity zones for hygroscopic APIs
• Effluent treatment plants and green chemistry systems

We scale from research quantities to multi-metric ton batches, without quality trade-offs.

Learn more about our advanced drug intermediates that support API innovation.

2. Stringent Analytical Testing

Every batch undergoes:

• HPLC, GC, FT-IR, and Mass Spectrometry profiling
• Particle size distribution checks for better bioavailability
• Melt point and polymorph identification for structural stability

All results align with IP, USP, and EP monographs, backed with full audit trails.

3. Robust Quality Documentation & Regulatory Support

We provide:

• Certificate of Analysis (COA)
• Material Safety Data Sheet (MSDS)
• Open & closed-part Drug Master File (DMF)
• Stability study data
• Impurity profiling & elemental impurity reports per ICH Q3D

Our Regulatory Affairs (RA) team assists clients across USFDA, EMA, ANVISA, and WHO submissions.

🔍 Explore Dapagliflozin API manufacturers in India for high-purity, GMP-compliant pharmaceutical ingredients.

 

Additional Advantages of Partnering with Bio-Synth

Flexible Packaging & Global Delivery
Choose from:

• Double-lined HDPE drums (vacuum sealed)
• Moisture-barrier aluminum pouches
• Smart labelling with QR documentation

Sustainable Manufacturing for Long-Term Partnerships
Our processes comply with EHS standards, using:

• Solvent recovery systems (>95% efficiency)
• Green solvent alternatives
• Zero-tab habitat emissions

This ESG focus makes Bio-Synth a qualified partner for environment-sensitive tenders and international pharma majors.

 

Applications of Dapagliflozin API from Bio-Synth

 

Formulation Type	Application
Film-coated tablets	Daily glucose control
Fixed-dose combinations	Combo therapies (e.g., + Metformin)
Bulk APIs for FDF partners	Tableting/blistering lines
Clinical trial supplies	Phase I–III formulations

 

Procurement Checklist: How to Choose the Best API Supplier

Before finalizing your API vendor, ensure the supplier offers:

✅ WHO-GMP certification
✅ Local regulatory approvals (CDSCO, DCGI)
✅ Valid DMF for your target market
✅ Batch CoA and RM traceability
✅ Transparency in pricing and lead times
✅ Past performance with major global clients

At Bio-Synth, we help procurement teams de-risk sourcing decisions and accelerate time to market.

 

FAQs About Dapagliflozin API and Bio-Synth

1) Why do global buyers prefer Indian API manufacturers?

India offers world-class pharma clusters like Hyderabad, lower production costs, skilled talent, and a regulatory-compliant ecosystem. Companies like Bio-Synth combine GMP quality with cost-efficiency.

2) What makes Bio-Synth stand out in Dapagliflozin production?

Our API exceeds 99% purity, uses a stable polymorph form, and comes with complete regulatory documentation. We enable customized batch sizes, rapid delivery, and scalable CDMO services.

3) Can buyers request stability data and custom documents?

Yes. We offer long-term (6–12 months) stability studies under ICH guidelines and can provide custom documentation packs depending on registration needs.

 

Final Thoughts: Your Dapagliflozin API Partner in India

With rising global demand for safer and effective anti-diabetic formulations, selecting a trusted API partner becomes mission-critical. Bio-Synth stands at the intersection of science, quality, and reliability—delivering high-purity Dapagliflozin Propanediol Monohydrate APIs that meet the most stringent global standards.

Whether you are a formulation company, CDMO, or generic drug developer, our team is ready to support you from R&D to commercial scale.

📩 Contact Bio-Synth today for bulk quotes, regulatory documentation, and CDMO collaboration.