Dapagliflozin API Quality Parameters | GMP Manufacturer India
Dapagliflozin API Quality Parameters | GMP Manufacturer India
Last Updated: January 2026
Dapagliflozin Propanediol Monohydrate API quality depends on ≥99% purity, stable polymorphic form, low impurity profile, ICH-compliant solvents, and complete regulatory documentation.
Bio‑Synth, a WHO-GMP–certified manufacturer based in Balanagar Industrial Area, Hyderabad, delivers globally compliant, high-purity Dapagliflozin APIs trusted by pharmaceutical buyers in 35+ countries.
Introduction: Why Dapagliflozin API Quality Matters Globally
Dapagliflozin Propanediol Monohydrate API is a cornerstone compound for Type 2 diabetes therapies worldwide. Its quality directly impacts:
- Drug safety
- Clinical efficacy
- Bioequivalence outcomes
- Regulatory approvals
Indian pharmaceutical manufacturers—particularly Bio-Synth—are emerging as preferred global suppliers due to robust GMP compliance, analytical rigor, and scalable production capabilities.
Founded in 1943, Bio-Synth operates WHO-GMP–certified facilities in Hyderabad and ensures consistent quality, regulatory readiness, and sustainable manufacturing.
This article explains:
- Critical Dapagliflozin quality parameters
- Best-practice manufacturing controls
- Why Bio-Synth is trusted by global pharmaceutical brands
Understanding Dapagliflozin Propanediol and Its API Applications
What is Dapagliflozin Propanediol Monohydrate used for?
Dapagliflozin Propanediol Monohydrate is a selective Sodium-Glucose Cotransporter-2 (SGLT2) inhibitor, widely prescribed for:
- Blood glucose control in Type 2 Diabetes Mellitus
- Cardiovascular risk reduction
- Slowing progression of chronic kidney disease
It is commonly formulated as:
- Monotherapy
- Fixed-dose combinations (FDCs) with metformin, sitagliptin, or empagliflozin
Why Is API Quality So Critical?
The therapeutic success of anti-diabetic drugs depends directly on API quality. Sub-standard APIs can lead to:
- Failed bioequivalence studies
- Regulatory observations or rejection letters
- Costly product recalls and brand damage
For this reason, procurement and quality teams must rigorously evaluate Dapagliflozin API quality parameters before finalizing suppliers.
Key Dapagliflozin Quality Parameters That Matter
| Parameter | Industry Benchmark | Impact |
| Purity level | ≥99% | Ensures potency and minimizes adverse reactions |
| Crystalline stability | Stable polymorph | Guarantees consistent dissolution & absorption |
| Impurity profile | <0.1% individual | Protects patient safety & speeds approvals |
| Residual solvents | ICH Q3C compliant | Prevents solvent-related toxicity |
| Batch consistency | RSD <2% | Enables reproducible formulations |
| Regulatory documents | CoA, MSDS, DMF | Accelerates global registrations |
These parameters directly affect cost-per-tablet, regulatory timelines, and market success.
Why India Leads in Dapagliflozin API Production
India supplies over 20% of the world’s generic medicines, making it a global API manufacturing powerhouse.
Key Advantages:
- Vertical integration of raw materials & intermediates
- Lower CapEx & OpEx for competitive pricing
- Mature regulatory ecosystem (WHO-GMP, USFDA, EU GMP)
- Pharma clusters like Hyderabad Genome Valley & Balanagar Industrial Area
For global buyers, this translates to lower risk, faster timelines, and supply continuity.
Bio-Synth: A Proven Dapagliflozin API Manufacturer in Hyderabad
Trusted Since 1943 — Our Manufacturing Legacy
Headquartered in Hyderabad, Telangana, Bio-Synth has built an eight-decade reputation for:
- WHO-GMP–certified manufacturing
- End-to-end API development
- Supplying regulated & semi-regulated markets in 35+ countries
We support B2B bulk manufacturing, CDMO partnerships, and lifecycle API supply for innovators and generic pharmaceutical companies.
How Bio-Synth Ensures High-Quality Dapagliflozin APIs
1. Advanced & Scalable Manufacturing Facilities
Our Hyderabad manufacturing unit features:
- Controlled temperature & humidity zones for hygroscopic APIs
- Effluent treatment plants & green chemistry systems
- Scalability from R&D quantities to multi-metric-ton batches
2. Stringent Analytical Testing
Each batch undergoes:
- HPLC, GC, FT-IR, and Mass Spectrometry
- Particle size distribution analysis
- Melting point & polymorph identification
All testing aligns with IP, USP, and EP monographs, supported by complete audit trails.
3. Robust Regulatory Documentation & Support
Bio-Synth provides:
- Certificate of Analysis (CoA)
- Material Safety Data Sheet (MSDS)
- Open & closed-part Drug Master Files (DMF)
- Stability studies (ICH compliant)
- Impurity & elemental impurity profiling (ICH Q3D)
Our Regulatory Affairs team supports submissions to USFDA, EMA, ANVISA, and WHO.
Additional Advantages of Partnering with Bio-Synth
Flexible Packaging & Global Delivery
Options include:
- Double-lined HDPE drums (vacuum sealed)
- Moisture-barrier aluminum pouches
- QR-enabled smart documentation
Sustainable Manufacturing & ESG Compliance
- Solvent recovery efficiency >95%
- Green solvent alternatives
- Zero-liquid-discharge processes
This makes Bio-Synth suitable for ESG-sensitive tenders and multinational pharma programs.
Applications of Dapagliflozin API from Bio-Synth
| Formulation Type | Application |
| Film-coated tablets | Daily glucose management |
| Fixed-dose combinations | Combination diabetes therapy |
| Bulk API supply | FDF manufacturing lines |
| Clinical trial material | Phase I–III studies |
Procurement Checklist: Choosing the Right Dapagliflozin API Supplier
Before finalizing a supplier, ensure availability of:
- WHO-GMP certification
- CDSCO / DCGI approvals
- Market-specific DMF
- Batch CoA & RM traceability
- Transparent pricing & lead times
- Proven global client track record
Bio-Synth helps procurement teams de-risk sourcing and accelerate time-to-market.
FAQs: Dapagliflozin API
1. Why do global buyers prefer Indian API manufacturers?
India offers advanced pharma clusters, skilled talent, cost efficiency, and strong regulatory compliance. Manufacturers like Bio-Synth combine GMP quality with global export expertise.
2. What differentiates Bio-Synth’s Dapagliflozin API?
Our API delivers ≥99% purity, stable polymorphic form, low impurities, and full regulatory documentation—supported by scalable manufacturing and rapid delivery.
3. Can buyers request stability data and customized documentation?
Yes. Bio-Synth provides ICH-compliant stability studies (6–12 months) and customized regulatory documentation tailored to target markets.
Final Thoughts: Your Trusted Dapagliflozin API Partner in India
As global demand for safe, effective anti-diabetic therapies continues to rise, selecting the right API partner is critical.
Bio-Synth delivers science-driven, GMP-compliant, and regulatory-ready Dapagliflozin Propanediol Monohydrate APIs, supporting customers from R&D to commercial scale.
Contact Bio-Synth today for bulk pricing, DMF access, or CDMO collaboration.
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