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Suppliers and packagers for generic pharmaceutical drug: EMPAGLIFLOZIN; LINAGLIPTIN
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EMPAGLIFLOZIN; LINAGLIPTIN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0164-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0597-0164-30) | 2015-01-30 |
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0164-39 | 30 BLISTER PACK in 1 CARTON (0597-0164-39) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 2015-01-30 |
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0164-90 | 90 TABLET, FILM COATED in 1 BOTTLE (0597-0164-90) | 2015-01-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: EMPAGLIFLOZIN; LINAGLIPTIN
Who Supplies Empagliflozin and Linagliptin to the Pharmaceutical Supply Chain?
What does the supplier map look like for empagliflozin?
Empagliflozin (API) is sourced through a multi-step network spanning API manufacturers, intermediate producers, and contract manufacturing organizations (CMOs) that formulate and package finished dosage forms. The supplier landscape is dominated by large Indian and Chinese API players plus European and Japanese firms with dedicated development and scale-up capability.
| API supply (empagliflozin) by country cluster | Cluster | Typical role in the chain | Supplier archetype |
|---|---|---|---|
| India | API manufacturing and scale-up | Generic API houses with DMF/CEP-linked production | |
| China | API and key intermediates | Integrated chemical manufacturers and API producers | |
| EU/Japan | Specialized intermediates, quality systems | Companies supplying regulated-grade intermediates and development supply |
| Finished dosage supply (empagliflozin) | Dosage form | Typical supplier profile | Key locations used in practice |
|---|---|---|---|
| Tablets (commercial brands) | Global CMO + brand owner manufacturing sites | EU/US and Asia fill-finish networks |
What does the supplier map look like for linagliptin?
Linagliptin (API) has a similar ecosystem structure, with additional weight on firms that specialize in DPP-4 inhibitor chemistry, chiral or stereochemical control (depending on route), and high-quality solid-state production for oral DPP-4 inhibitor tablets.
| API supply (linagliptin) by country cluster | Cluster | Typical role in the chain | Supplier archetype |
|---|---|---|---|
| India | API manufacturing and finished dosage CDMO support | Regulated-market capable API manufacturers | |
| China | Intermediates and API | Large-scale chemical manufacturers with multiple routes | |
| EU | Tablet formulation capability | Formulation/analytical CDMOs supporting quality packages |
| Finished dosage supply (linagliptin) | Dosage form | Typical supplier profile | Typical manufacturing approach |
|---|---|---|---|
| Tablets | CMO for blend, compression, coating, packaging | Site-qualified solid dose manufacturing with validated analytical methods |
Supplier Lists: Empagliflozin and Linagliptin (API and CDMO footprints)
Which companies supply empagliflozin APIs and related manufacturing services?
| Supplier | Supply scope | Footprint signal used in industry qualification |
|---|---|---|
| Boehringer Ingelheim (brand owner) | Commercial supply for branded combination therapy | Established manufacturing network for Jardiance and related products |
| Indian API manufacturers (DMF-linked) | Empagliflozin API and development supply | Regulated API supply into global markets |
| Chinese API manufacturers | Intermediates and API scale | Cost-competitive supply for generics |
| Global CDMOs | Formulation, coating, packaging | Supports oral solid dose manufacturing scale-up |
Which companies supply linagliptin APIs and related manufacturing services?
| Supplier | Supply scope | Footprint signal used in industry qualification |
|---|---|---|
| Boehringer Ingelheim (brand owner) | Commercial supply for branded linagliptin therapy | Established manufacturing network for Tradjenta |
| Indian API manufacturers (DMF-linked) | Linagliptin API and development supply | Regulated API supply into global markets |
| Chinese API manufacturers | Intermediates and API scale | Cost-competitive supply for generics |
| Global CDMOs | Formulation, coating, packaging | Supports oral solid dose manufacturing scale-up |
Contracting and Qualification: How buyers typically structure supplier selection
What qualification artifacts matter for empagliflozin and linagliptin suppliers?
| Qualification artifact | Why it matters | How it appears in supplier due diligence |
|---|---|---|
| DMF/CEP documentation | Confirms regulatory status and data access | DMF holder or listed manufacturing site approvals |
| Analytical package | Confirms identity, purity, and polymorph control | Method validation and COA-based release specs |
| Solid-state control (polymorph/particle size) | Impacts dissolution and stability | Specs aligned to dossier and internal QbD approach |
| GMP inspection history | Reduces compliance risk | Inspection outcomes for the manufacturing site |
| Supply chain traceability | Reduces substitution and impurity risk | Intermediate sourcing and change-control governance |
What commercial contracting terms differ by API vs finished dose suppliers?
| Contract element | API supplier | Finished-dose CMO |
|---|---|---|
| Change control | Route, impurity profile, and site transfers | Process changes, scale-up validation, packaging changes |
| Release testing | API spec and stability-based retesting | In-process controls and finished product release testing |
| Lead times | API manufacturing batch scheduling | Blending, compression, coating, labeling, packaging run dates |
| Quality agreement | Site qualification and material transfer | Cross-site responsibilities for deviation, CAPA, audit scope |
Competitive Reality for R&D and Investment Decisions
How concentrated is supply for these APIs?
- Both empagliflozin and linagliptin are mature products, and supply is wide, but qualification is narrow: only suppliers with validated impurity profiles, stable solid-state behavior, and regulated documentation get approved at scale.
- Brand owners and their supply chains remain important for branded combination therapies, while generic entry depends on DMF-ready API capacity and reliable CMO networks for solid dose.
What matters most in vendor selection for these molecules?
| Decision factor | Empagliflozin and linagliptin impact |
|---|---|
| Impurity control | DPP-4 and SGLT2 inhibitor routes demand tight impurity specification management |
| Analytical method robustness | Required for consistent release and stability support |
| Solid dose manufacturability | Tablet compression and dissolution profiles must remain stable across batches |
| Change-control execution | Buyers need fast but controlled transitions to maintain regulatory alignment |
Key Takeaways
- Empagliflozin and linagliptin supply is delivered through a layered network of API manufacturers, intermediate producers, and solid-dose CMOs.
- India and China dominate API and intermediate production footprints; brand owners maintain key roles in commercial supply for branded therapies.
- Qualification, not headline supply count, drives real procurement: DMF/CEP readiness, impurity and solid-state control, and GMP inspection history determine which suppliers can pass fast-track onboarding.
- Contracting differs materially between API and finished-dose suppliers due to change control, release testing scope, and cross-site responsibilities.
FAQs
1) Can the same supplier source both empagliflozin and linagliptin?
Yes in practice, but qualification and inventory control must cover both APIs’ impurity profiles, solid-state properties, and dossier-aligned specifications.
2) Is API supply the main bottleneck for launches of empagliflozin or linagliptin products?
No. API availability is necessary but finished-dose manufacturing readiness, analytical package alignment, and regulatory documentation access typically define the real bottleneck.
3) Do brand-owner supply chains affect generic supplier selection?
They do, via established manufacturing networks, tighter quality systems, and the presence of supplier relationships that can restrict competitive access to preferred intermediates or capacity.
4) What evidence best supports a supplier’s ability to scale empagliflozin or linagliptin?
A proven DMF-linked manufacturing site, stable COA performance over multiple batches, documented solid-state behavior, and GMP inspection outcomes for the production site.
5) What is the fastest path to qualification for a new supplier of these APIs?
Using suppliers with existing regulated-market documentation and validated impurity and solid-state controls aligned to the buyer’s target specification and dossier expectations.
References
[1] Boehringer Ingelheim. Product information and manufacturing-related disclosures for Jardiance (empagliflozin) and Tradjenta (linagliptin).
[2] EMA and FDA product labeling and regulatory documents for empagliflozin-containing and linagliptin-containing products.
[3] European Medicines Agency (EMA). Public assessment and product information supporting regulated-quality expectations for oral solid dose APIs.
[4] FDA. Drug approvals and labeling records for empagliflozin and linagliptin products.
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