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Suppliers and packagers for generic pharmaceutical drug: EXENATIDE SYNTHETIC
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EXENATIDE SYNTHETIC
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6512-01 | 1 CARTRIDGE in 1 CARTON (0310-6512-01) / 1.2 mL in 1 CARTRIDGE | 2014-12-10 |
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6524-01 | 1 CARTRIDGE in 1 CARTON (0310-6524-01) / 2.4 mL in 1 CARTRIDGE | 2014-12-12 |
| Amneal | EXENATIDE SYNTHETIC | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 206697 | ANDA | Amneal Pharmaceuticals LLC | 70121-1685-1 | 1 CARTRIDGE in 1 CARTON (70121-1685-1) / 1.2 mL in 1 CARTRIDGE | 2024-11-22 |
| Amneal | EXENATIDE SYNTHETIC | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 206697 | ANDA | Amneal Pharmaceuticals LLC | 70121-1686-1 | 1 CARTRIDGE in 1 CARTON (70121-1686-1) / 2.4 mL in 1 CARTRIDGE | 2024-11-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: EXENATIDE SYNTHETIC
What suppliers make synthetic exenatide?
Synthetic exenatide supply is typically structured in three tiers: peptide ingredient manufacturers (API), peptide CMO/CDMO for custom synthesis and analytics, and specialty chemical distributors that carry exenatide or peptide building blocks. Without jurisdiction- and grade-specific constraints (clinical, commercial, or research), the supplier universe is broad and product labeling varies by “exenatide” vs “exenatide acetate” vs “peptide intermediates.”
Who supplies synthetic exenatide (API/peptide) in the market?
Below is a supplier set commonly associated with peptide manufacturing or peptide-grade supply chains that include exenatide and closely related GLP-1 analog peptide work. Availability depends on requested form (e.g., exenatide vs exenatide acetate), documentation package (CoA, GMP/DMF), and regulatory status (R&D only versus cGMP).
| Supplier category | Supplier (examples) | Typical offering | Product fit for “synthetic exenatide” |
|---|---|---|---|
| Peptide API / custom synthesis (CMO/CDMO) | WuXi AppTec (peptide services), WuXi Biologics (network), Thermo Fisher Scientific (custom peptide/analytical network) | Custom peptide synthesis, purification, impurity profiling, method development | Suitable for peptide API or reference standards depending on grade and compliance |
| Peptide synthesis specialists | Bachem (peptides), PolyPeptide Group (peptides), GL Biochem (peptides and intermediates) | Solid-phase peptide synthesis, purification, analytical release packages | Often supplies exenatide or related GLP-1 peptide targets in bulk or lab scale |
| API ingredient / specialty chemical distribution | Sigma-Aldrich/Merck, Cayman Chemical, Tocris/Bio-Techne (research-grade peptides) | Catalog peptide products for research use | Common route for analytical standards, assay development, and method validation |
| Managed peptide manufacturing networks | Lonza (peptide services through network), Charles River (analytical/contract support in some regions) | End-to-end peptide support via CDMO arrangements | Used when clinical-grade documentation is required via project setup |
Data point anchors (catalog and peptide supplier references): Merck’s Sigma-Aldrich catalog lists exenatide as a peptide standard for research use (Sigma-Aldrich product listings). GL Biochem is a peptide supplier with an exenatide page in its catalog ecosystem. PolyPeptide and Bachem operate peptide manufacturing programs with GLP-1 type sequences in their product/service portfolios, frequently including exenatide in customer requests (vendor catalogs and peptide service pages). [1][2][3][4]
Which suppliers are most relevant by supply objective?
If the goal is cGMP peptide API supply (commercial/clinical)
The shortlist typically includes large peptide CDMOs with GMP capability and established peptide impurity analytics workflows:
- WuXi AppTec (peptide manufacturing services under GMP frameworks for custom peptide projects) [1]
- PolyPeptide Group (peptide manufacturing and scale-up programs) [2]
- Bachem (peptide API manufacturing and custom peptide services) [3]
- Lonza (peptide and biologics CDMO networks; project-by-project compliance) [4]
These players are the ones procurement teams target when they need batch documentation, validated analytical methods, and controlled supply chains that align with clinical or commercial requirements.
If the goal is R&D grade material (standards, method validation, assays)
The most direct routes are catalog suppliers for exenatide or exenatide acetate:
- Sigma-Aldrich/Merck (catalog research peptide) [1]
- Cayman Chemical (research peptide catalog) [5]
- Tocris (Bio-Techne) (research peptide catalog) [6]
This route is typically used for:
- in vitro binding and activity assays
- LC-MS method development
- reference standard preparation
What does “synthetic exenatide” mean in supplier specs?
Vendors often differentiate by:
- Salt form: exenatide vs exenatide acetate
- Purity grades: research grade (often purity listed without GMP) vs pharmaceutical-grade (CoA and release specs)
- Analytical package: HPLC/UPLC purity, identity by MS, endotoxin and sterility (for higher-grade lots), residual solvents (if relevant), and impurity profiling
- Packaging: lyophilized vials vs bulk powder
- Chain of custody: export documentation and traceability for controlled substances are managed differently by R&D vs cGMP suppliers
Your procurement process should map supplier deliverables to the intended use stage, because the same vendor may offer exenatide under different compliance tiers.
Supplier mapping by product form (exenatide vs exenatide acetate)
In practice, most commercial and assay use cases reference exenatide acetate. Catalog listings sometimes name “exenatide” even when they provide an acetate salt.
| Product form used in documents | Typical supplier presence | Notes for procurement |
|---|---|---|
| Exenatide | Sigma-Aldrich/Merck; Cayman; Tocris; multiple peptide specialists | Common for reference standards and screening |
| Exenatide acetate | peptide specialists and API networks | Aligns with typical marketed salt naming in formulations and specs |
Operational takeaway: ask for the exact chemical name and salt form in the purchase order. Many rejections come from mismatched salt form rather than peptide identity.
How procurement teams vet suppliers for synthetic exenatide
Standard qualification checkpoints used by sourcing and quality teams:
- Analytical identity: mass confirmation (LC-MS/HRMS) and retention time against reference
- Purity/impurities: impurity profile is especially important for GLP-1 analogs because small truncations and deamidation variants can affect activity and stability
- Residuals and safety: endotoxin, bioburden, and sterility for injection-appropriate grades
- Stability and handling: storage temperature, lyophilized integrity, and reconstitution instructions
- Regulatory footprint: GMP status, CoA format, and DMF/CEP availability (project-dependent)
Where synthetic exenatide suppliers fit in the supply chain
You can structure the sourcing plan as:
- Peptide API manufacturers (CMO/CDMO) for clinical/commercial-grade work
- Reference standard suppliers for lab scale and validation
- Specialty distributors for quick availability of standards and small research quantities
A typical strategy is to use catalog suppliers to accelerate early assay development, then transfer method qualification to cGMP material supplied by a peptide API CDMO once the target dose and impurity spec are locked.
Key Takeaways
- Synthetic exenatide supply splits into cGMP peptide CDMOs (WuXi AppTec, PolyPeptide, Bachem, project networks like Lonza) and research-grade catalog suppliers (Sigma-Aldrich/Merck, Cayman, Tocris).
- Supplier selection depends on form (exenatide vs exenatide acetate), grade (R&D vs cGMP), and the documentation package required for the stage of development.
- Procurement should prioritize identity and impurity analytics for GLP-1 analog peptides, since purity and impurity profile can drive bioactivity and stability outcomes.
- Catalog suppliers are best for early-stage work; CDMOs are best for clinical/commercial readiness.
FAQs
1) Which supplier types can provide synthetic exenatide?
Peptide CDMOs/custom synthesis providers for GMP work and research-grade catalog suppliers for standards and assay development.
2) Do suppliers sell exenatide and exenatide acetate under the same listing?
Listings often differ by naming convention; many vendors carry both or interchange “exenatide” with the acetate salt in catalog language. Confirm the salt form on the PO.
3) What documentation matters most for exenatide material?
A CoA with identity and purity (HPLC/UPLC) plus impurity and MS confirmation; for injection-relevant grades, endotoxin/sterility and safety release parameters.
4) Can I source exenatide from a distributor instead of a CDMO?
Yes for R&D grade and reference standards. For clinical/commercial API, procurement generally shifts to peptide API CDMOs with GMP controls.
5) What is the fastest path for early assay readiness?
Use a catalog supplier (Sigma-Aldrich/Merck, Cayman, Tocris) for reference material while qualification runs in parallel, then lock a cGMP source via a peptide CDMO once specifications are stable.
References
[1] Sigma-Aldrich/Merck. Exenatide product listings. Merck/Sigma-Aldrich catalog (accessed 2026-04-24).
[2] PolyPeptide Group. Peptide manufacturing and custom synthesis services (vendor product/service pages; exenatide typically handled as GLP-1 peptide requests). (accessed 2026-04-24).
[3] Bachem. Peptide manufacturing and custom synthesis services (vendor product/service pages; GLP-1 analog peptides including exenatide handled via customer programs). (accessed 2026-04-24).
[4] WuXi AppTec. Peptide synthesis and manufacturing services (vendor product/service pages). (accessed 2026-04-24).
[5] Cayman Chemical. Exenatide (research reagent) product page. (accessed 2026-04-24).
[6] Tocris (Bio-Techne). Exenatide (research reagent) product page. (accessed 2026-04-24).
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