Dapagliflozin API for Export: Key Markets, Guidelines & Regulatory Requirements

Dapagliflozin API for Export: Key Markets, Guidelines & Regulatory Requirements

Dapagliflozin Propanediol Monohydrate is a highly effective SGLT2 inhibitor for type 2 diabetes treatment. Its global demand has made India, especially Hyderabad, a sourcing hub for API buyers. Bio-Synth, a WHO-GMP certified manufacturer in Hyderabad’s Balanagar Industrial Area, provides premium-quality Dapagliflozin API with strong regulatory documentation. This article covers markets, compliance, and Bio-Synth’s B2B & CDMO capabilities.

Why Dapagliflozin API Demand Is Rising?

The global diabetes epidemic is driving demand for effective oral hypoglycemics like Dapagliflozin.

Key Benefits:

• Improves glycemic control (via urinary glucose excretion)

• Provides cardiovascular & renal protection

Applications:

• Monotherapy tablets

• Fixed-dose combinations (FDCs) with metformin, glimepiride, etc.

• Long-term chronic-care therapies

Buyer Expectations:

• Purity ≥99%

• Consistent crystalline structure

• Transparent regulatory support

India’s Role in Global API Exports

India supplies 20%+ of global generics, with Hyderabad known as the “Bulk Drug Capital of India.”

Why Buyers Prefer Indian Manufacturers

Factor	Benefit
Cost Efficiency	Competitive pricing without compromising quality
Regulatory Approvals	WHO-GMP, USFDA, EU-GMP, TGA certifications
B2B Flexibility	From pilot batches to commercial exports
CDMO Support	End-to-end manufacturing for global clients

 

📍 Bio-Synth’s WHO-GMP facility in Hyderabad ensures easy access to global logistics networks.

Understanding Dapagliflozin Propanediol Monohydrate

Dapagliflozin, in its propanediol monohydrate form, offers high solubility and stability.

How it Works:

• Inhibits SGLT2 in kidneys

• Reduces glucose reabsorption

• Improves glycemic control in T2DM

Therapeutic Uses:

• Type 2 diabetes monotherapy

• FDCs in regulated markets

• Cardiovascular therapies

• IND-based clinical research

Export Compliance: Regulatory Guidelines

When exporting APIs, regulatory documentation is critical.

Document	Purpose
DMF (Drug Master File)	Chemistry & manufacturing details
COA (Certificate of Analysis)	Batch-specific quality data
MSDS	Safe handling guidance
Stability Data	Long-term API integrity
Impurity Profile & Method Validation	Supports dossier approval

 

👉 Bio-Synth provides US/EU/Canada-specific DMFs with real-time & accelerated stability studies.

Choosing the Right API Manufacturer

Core Quality Parameters

• Purity ≥99.5%

• Controlled crystalline polymorph

• Particle size distribution (PSD)

• Low solvents & heavy metals

• Pharmacopeial microbial limits

Manufacturing Standards

• WHO-GMP certified plant

• ISO 9001:2015, environmental compliance

• In-process QC monitoring

• Commercial & R&D scalability

🔍 Learn more about different types of APIs Bio-Synth manufactures.

Bio-Synth: Trusted Exporter of Dapagliflozin API

With 80+ years of pharma manufacturing, Bio-Synth is a reliable partner for B2B buyers.

• Quality Assurance

• ATR-FTIR, HPLC, GC-MS, KF testing

• COAs compliant with IP/USP/EP

• Stability & impurities monitored by QA teams

• Regulatory Strength

• Open & Restricted DMFs

• CTD/ACTD dossier support

• ICH-compliant QbD processes

• Scalable Supply

• 25+ MT annual capacity

• From 1 kg pilot orders to multi-ton shipments

• Custom nitrogen-flushed HDPE packaging

• Integrated CDMO Services

• Route optimization & impurity profiling

• Salt selection & polymorph studies

• Advanced intermediates & technology transfers

Global Demand for Dapagliflozin API

• North America: US, Canada

• Europe: Germany, UK, Spain

• MENA: UAE, Egypt, Saudi Arabia

• Asia: Japan, Korea, Vietnam

• LATAM: Brazil, Mexico, Argentina

Sustainability & Worker Safety

🌱 Eco-Friendly Practices

• ETP-based waste management

• Solvent recovery systems

• Energy-efficient reactors

👷 Workforce Protection

• Closed-loop handling of sensitive APIs

• OSHA-aligned safety training

• OEL mapping for exposure control

Bio-Synth at a Glance

 

Feature	Details
Location	Hyderabad, Balanagar Industrial Area
Certifications	WHO-GMP, ISO 9001:2015
Key API	Dapagliflozin Propanediol Monohydrate
Purity	≥99.5%
Documentation	DMF (US/EU), COA, MSDS, Stability Data
Capacity	25+ MT annually
B2B Support	CDMO, contract manufacturing, tech transfer

FAQs

1. Why do global buyers trust Indian API exporters like Bio-Synth?
Because India combines cost efficiency with WHO-GMP/USFDA/EU GMP standards. Bio-Synth ensures global compliance & scalable supply.

2. What’s the shelf life & packaging of Dapagliflozin API?
Shelf life: 36 months. Packaging: nitrogen-flushed HDPE drums with double liners, optimized for sea & air transport.

3. Does Bio-Synth support regulatory filing?
Yes — with DMF submissions, dossier prep & method validation assistance.

Final Thoughts

The therapeutic value of Dapagliflozin continues to grow worldwide. Partnering with a reliable supplier like Bio-Synth ensures formulation stability, regulatory compliance, and patient safety.

📩 Contact Bio-Synth today for bulk quotes, regulatory support, and CDMO partnerships.