Dapagliflozin API Certifications: How to Choose Globally-Compliant API Suppliers from India
Dapagliflozin API Certifications: How to Choose Globally-Compliant API Suppliers from India
Dapagliflozin API, a critical active pharmaceutical ingredient for type 2 diabetes treatment, requires stringent regulatory compliance from its manufacturers. For B2B buyers, sourcing Dapagliflozin with the right certifications like WHO-GMP, USDMF, CEP, and KDMF is essential to meet global regulatory standards and market readiness.
India, led by industrial pharma hubs like Hyderabad, is home to globally trusted API suppliers with robust quality credentials. Bio-Synth, a Hyderabad-based WHO-GMP certified API manufacturer, offers certified Dapagliflozin and other APIs, serving pharma clients across regulated and emerging markets.
🔍 Explore Bio-Synth’s API catalog for high-purity, GMP-compliant pharmaceutical ingredients.
Why Dapagliflozin API Certifications Matter in Global Pharma Markets
Dapagliflozin (CAS No. 461432-26-8) is a selective SGLT2 inhibitor used widely in the formulation of antidiabetic medicines. Given its therapeutic value and regulatory demands, selecting a well-certified manufacturer is not optional—it’s essential.
Global regulatory authorities such as the US FDA, European Medicines Agency (EMA), and PMDA (Japan) require detailed documentation for API compliance, including:
- Drug Master Files (DMFs) like USDMF or JDMF
- GMP adherence (WHO-GMP, EU-GMP, cGMP)
- Certificates of Suitability (CEP/COS) from EDQM
- Stability and impurity profiles
Manufacturers who maintain these documents ensure quality, consistency, and marketability across various countries.
India’s Role as a Trusted Dapagliflozin API Manufacturing Hub
Why Hyderabad Leads in API Manufacturing
Hyderabad, specifically the Balanagar Industrial Area, is a central node in India’s pharmaceutical supply chain. With over 75 years of pharma manufacturing legacy and access to a skilled labor force, Hyderabad is home to regulatory-compliant plants and CDMOs that export to over 100 countries.
As of 2023, India supplies over 20% of global generic exports, with a significant proportion involving regulated-market APIs, including Dapagliflozin.
Key reasons India stands out:
- Cost-efficient production without compromising quality
- Strong regulatory approvals (over 900 US FDA-compliant facilities)
- Government push via schemes like PLI (Production Linked Incentives)
Bio-Synth exemplifies these standards, operating a WHO-GMP facility in Hyderabad that delivers high-quality Dapagliflozin API and other therapeutic APIs.
Key Certifications for Dapagliflozin API: What to Look For
Here’s a breakdown of the crucial regulatory documents and why they matter:
| Certification | Full Form | Purpose | Issued By |
| USDMF | Drug Master File (USA) | Detailed information on the manufacturing, processing, and packaging | US FDA |
| CEP (COS) | Certificate of Suitability | Confirms API meets EU Ph. standards | EDQM |
| JDMF/KDMF | Japan/Korea DMF | Required for registration in Japan or Korea | PMDA/MFDS |
| WHO-GMP | Good Manufacturing Practice | Confirms manufacturing quality is maintained internationally | WHO |
| COA | Certificate of Analysis | Batch-level quality test report | Manufacturer |
| GMP | Local or international GMP | Confirms plant adheres to expected quality norms | National drug regulatory bodies |
Choosing a vendor with 2 or more of these certifications ensures seamless registration and approval in international markets.
Evaluating a Dapagliflozin Manufacturer: What Procurement Teams Must Verify
To simplify your sourcing strategy, use this 5-point vendor audit checklist before engaging with a new API supplier:
- Regulatory Filings: Confirm they hold USDMF/CEP and provide Open Part of DMF if needed.
- Facility Standards: Visit/examine GMP compliance reports or WHO inspection summaries.
- Analytical Documents: Ask for CoAs, impurity profiles, and ICH stability data.
- Supply Consistency: Review current production capacity and past delivery records.
- CDMO Capabilities: Can they support pre-formulation, scale-up, or tech transfer?
Outsourcing to WHO-GMP-compliant CDMOs such as Bio-Synth reduces your audit time and ensures repeatable production integrity.
How Bio-Synth Meets Global Certification Needs for Dapagliflozin and Other APIs
Why B2B Clients Choose Bio-Synth
Operating since 1943, Bio-Synth is not just one of the earliest pharma manufacturers from India but also among the most reliable API exporters from Hyderabad. The company is known for:
- Fully WHO-GMP compliant facility – located in Balanagar Industrial Estate, Hyderabad
- End-to-end API production process – including synthesis, validation, documentation, and packaging
- Regulatory experience – with track record of documentation for USDMF, CEP, and other filings
- Customization & CDMO support – scale-up from grams to metric tons across therapeutic classes
🔍 Explore Bio-Synth’s pharmaceutical intermediates for high-purity, GMP-compliant pharmaceutical ingredients.
CDMO Support for Formulators and Global Brands
Many global formulators, from finished dosage manufacturers to biotech innovators, need technical support beyond API supply. Bio-Synth also offers:
- Tech transfer assistance
- Impurity synthesis and isolation
- Custom salt form development
- Batch validation for regulated filings
Whether you’re filing an ANDA or preparing for an EU submission, Bio-Synth acts as a dependable long-term API partner.
Dapagliflozin API Market Trends and Pricing Signals
The global Dapagliflozin market is expected to reach USD 5.2 billion by 2028, thanks to growing diabetes incidence and expanded use in heart failure treatment.
However, API pricing remains dynamic, driven by:
- Patent expirations & generic entry
- API route optimization, reducing cost
- Active compliance by suppliers to meet regulator demands
Therefore, buying certified APIs from India helps firms boost margins and accelerate market access.
FAQs
- Why do buyers trust Indian APIs like Dapagliflozin?
India offers proven quality, WHO-GMP compliance, and low-cost scalability. With over 900 US FDA-approved plants, Indian firms lead global API exports.
- What documents do I need when sourcing Dapagliflozin API?
At minimum, request a WHO-GMP certificate, DMF (USDMF or JDMF), and a Certificate of Analysis. This ensures global regulatory acceptance.
- Can Bio-Synth support formulation-level CDMO services?
Yes. Bio-Synth offers pre-formulation, analytical method development, and process validation support for regulatory filings globally.
📩 Contact Bio-Synth today for bulk quotes, regulatory documentation, and CDMO collaboration.
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