DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Msn	DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	211533	ANDA	Novadoz Pharmaceuticals LLC	72205-438-01	30 TABLET, FILM COATED in 1 BOTTLE (72205-438-01)	2026-04-06
Msn	DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	211533	ANDA	Novadoz Pharmaceuticals LLC	72205-438-02	90 TABLET, FILM COATED in 1 BOTTLE (72205-438-02)	2026-04-06
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 25, 2026

Executive summary: Dapagliflozin and saxagliptin hydrochloride are supplied through (1) API and intermediate producers for global generics and branded manufacturers, (2) contract manufacturers (CDMOs) for solid oral dosage forms, and (3) packaging and secondary-supply chains. For business planning, supplier risk is driven less by “number of suppliers” and more by DMF status, CEP/ASMF coverage, DMF-to-site traceability, and whether suppliers can support impurity profiles and process validation for US FDA ANDA filings.

Scope note: This supplier map covers the typical supplier categories used for dapagliflozin and saxagliptin hydrochloride programs. It does not validate any single company’s live regulatory standing for a specific DMF or site at a specific date.

Who supplies dapagliflozin API and key intermediates?

Dapagliflozin (SGLT2 inhibitor) supply typically spans: (a) glucoside-bond forming chemistry intermediates, (b) heteroaryl/aryl construction intermediates, (c) chiral alcohol or glycosylation steps, and (d) final API purification and crystallization under tight impurity control.

Common supplier categories

API manufacturers: produce dapagliflozin drug substance and support global DMF and/or ASMF submissions.
Intermediate suppliers: provide advanced intermediates used to reduce cycle time and cost for API synthesis.
CDMOs for tablets: develop and manufacture dapagliflozin tablets at scale, including blend, granulation, compression, coating, and stability packaging.

API supply reality for ANDA programs

For dapagliflozin generics, the operational gating items are usually:

impurity specification alignment with the reference-listed API
ability to consistently hit polymorph/crystal form targets
consistent chiral purity (where applicable in process design)
documentation packages (DMF/ASMF, test methods, validation reports) that match ANDA expectations

Who supplies saxagliptin hydrochloride API and key intermediates?

Saxagliptin hydrochloride (DPP-4 inhibitor) supply chains usually emphasize:

heteroaromatic core formation
nitrile or substituted amide transformations depending on route
salt formation and controlled crystallization for the hydrochloride
impurity control in the final API (process-related and degradation-related)

Common supplier categories

API manufacturers: saxagliptin hydrochloride drug substance for branded and generic cycles.
Intermediate suppliers: advanced intermediates reduce time-to-API and mitigate process scale-up risk.
CDMOs: solid oral dosage CDMO partners for tablets including coating systems and release testing.

Operational gating items

For saxagliptin ANDAs and lifecycle management, typical gating items include:

salt form reproducibility (hydrochloride)
impurity profile tightness
particle size distribution and flow properties for blending
analytical method transfer feasibility (HPLC/UPLC stability-indicating methods)

What companies are major global API suppliers for SGLT2 and DPP-4 inhibitors?

Suppliers for dapagliflozin and saxagliptin hydrochloride often come from the same global cohort that supplies other high-value oral diabetes drugs. These companies typically offer:

regulated API manufacturing (US/EU-facing quality systems)
scalable intermediate and API routes
CDMO services for finished dosage forms

Supplier roster (API and CDMO ecosystem)

Note: The list below is structured as a supplier ecosystem map. It is not limited to only dapagliflozin or only saxagliptin; many suppliers serve multiple diabetes inhibitor portfolios.

API/CDMO suppliers commonly used in oral solid and diabetes inhibitor supply chains

Cipla (API and dosage manufacturing footprint across generics)
Dr. Reddy’s Laboratories (API and formulations; quality systems for global markets)
Sun Pharmaceutical Industries (API + formulations)
Lupin (API and drug product manufacturing)
Aurobindo Pharma (API and drug product network)
Mylan/MVi-aligned legacy networks (generic supply chain ecosystem)
Teva (API and drug product capacity via branded/generic operations)
Hetero Drugs (API + formulations)
AstraZeneca supply chain ecosystem for branded products (route and site dependent)

Specialist India-based API and intermediate manufacturers serving regulated markets

Cadila Healthcare / Zydus ecosystem
Torrent Pharmaceuticals’ supply ecosystem
Aishwarya / smaller intermediate specialists (often route-specific advanced intermediates)

Because supplier suitability must match a specific DMF and a specific site, business diligence usually validates:

which DMF (or CEP/ASMF) is active
whether the commercial API is made at the DMF-linked facility
batch release testing scope and method availability for transfer

Which CDMOs make dapagliflozin and saxagliptin tablets?

Both drugs are typically supplied as oral solid tablets and require:

controlled granulation and compression
coating and film properties
stability studies with humidity control
packaging validation for dose accuracy and moisture protection

CDMO capabilities that matter

blending uniformity and low cross-contamination controls
dissolution method alignment (especially for ANDA readiness)
scale-up from pilot to commercial with consistent impurity results
stability program design for water-sensitive drug products

CDMO ecosystem patterns

Global CDMOs usually handle multiple solid oral products and provide analytical method development and tech transfer.
API-integrated manufacturers sometimes perform drug product in-house to reduce supply variability.

What does supplier qualification require for dapagliflozin and saxagliptin projects?

Supplier qualification for regulated filings is dominated by documentation and process reproducibility.

Core qualification checklist

Regulatory dossier linkage: DMF/ASMF or CEP coverage mapped to the manufacturing site
GMP compliance: facility inspection history and current compliance status
Analytical method transfer: HPLC method availability, validation, and impurity standard strategy
Impurity and stability: impurity list alignment, spec limits, and forced degradation strategy
Physical form control: polymorph or hydrate status where relevant
Chain of custody: temperature/humidity controls for intermediates and drug substance storage
Batch-to-batch performance: CoA consistency and yield reproducibility

Due diligence deliverables buyers typically demand

CoA for development batches and 3 to 5 consecutive commercial-like batches
GMP certificates and audit reports for the exact site
full impurity profile reports with method descriptions
route-of-synthesis summary for risk scoring

Where do intermediate suppliers fit in the dapagliflozin and saxagliptin value chain?

Intermediate supply reduces:

time-to-market
cost of upstream chemistry
exposure to capacity bottlenecks in final API steps

Intermediate sourcing strategies

Option A: buy advanced intermediates and finish API synthesis in-house
Option B: buy API only and handle only dosage manufacturing
Option C: integrated API + drug product from one qualified partner

Risk points for intermediates

impurity carryover to final API
inconsistent intermediate polymorph or residual solvents
incomplete analytical disclosure that blocks method transfer

How do you compare supplier strength between dapagliflozin and saxagliptin?

Supplier strength depends on whether the chemistry route is:

capital-intensive and bottlenecked (fewer suppliers able to meet tight specs)
or handled through more common commodity-like transformations

Comparison (high-level)

Dapagliflozin: supply is often constrained by complex heterocycle/glycosylation-type steps and chiral or sensitive transformations (route dependent).
Saxagliptin hydrochloride: supply is often constrained by salt formation control, impurity management, and route reproducibility rather than only complexity of heterocycle assembly.

Practical takeaway: both can be sourced from multiple vendors, but only a subset typically supports filings at the impurity and form-control level required for ANDA readiness.

What generic launch risks exist if supplier quality drifts?

For dapagliflozin and saxagliptin, quality drift triggers:

regulatory delays from failure to meet specs
change control events (process changes requiring comparability packages)
stability failures due to moisture ingress or form instability
batch rejection due to impurity excursions

Common triggers

solvent residual excursions in intermediates
impurity spikes after process parameter changes
particle size distribution shift affecting dissolution performance

Key Takeaways

Dapagliflozin and saxagliptin hydrochloride are sourced via a structured chain: API intermediates → API drug substance → tablet CDMO or integrated manufacturers.
Supplier selection hinges on regulatory dossier linkage (DMF/ASMF or CEP), site-specific GMP status, and demonstrated impurity and form control, not just “availability.”
Intermediate suppliers can reduce development time but increase impurity carryover and method transfer risk.
For execution-focused procurement, qualification should prioritize analytical method transfer capability and batch-to-batch CoA consistency.

FAQs

1) What supplier documentation is required for ANDA-ready dapagliflozin API?
DMF/ASMF linkage to the manufacturing site, full impurity profile, validated analytical methods, CoAs for consecutive batches, and stability data packages that support the proposed API specification.

2) What is the key quality risk for saxagliptin hydrochloride API supply?
Salt form consistency and impurity control that aligns with the approved reference API profile and dissolution performance expectations downstream.

3) Can the same CDMO manufacture both dapagliflozin and saxagliptin tablets?
Yes, most regulated solid oral CDMOs can run multiple actives, but cross-contamination control, method transfer, and validated cleaning strategies must be confirmed for each product line.

4) How do intermediate suppliers affect regulatory timelines for diabetes inhibitor generics?
They can shorten upstream cycle time, but qualification and impurity disclosure can lengthen timelines if analytical comparability cannot be demonstrated quickly.

5) What procurement structure reduces launch slippage for these drugs?
Dual-sourcing for drug substance and a verified second qualification track for drug product manufacturing, combined with strict batch-release and change-control covenants.

References (APA)

FDA. (n.d.). Drug Approval Reports and related regulatory information for ANDAs, DMFs, and listed products. U.S. Food and Drug Administration.
FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
EMA. (n.d.). European public assessment reports and regulatory documents for drug substance and product dossiers. European Medicines Agency.

Suppliers and packagers for generic pharmaceutical drug: DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE