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Suppliers and packagers for CEFTRIAXONE
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CEFTRIAXONE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Acs Dobfar | CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INJECTION | 065329 | ANDA | Sagent Pharmaceuticals | 25021-106-10 | 25 VIAL in 1 CARTON (25021-106-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | 2009-11-05 |
| Acs Dobfar | CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INJECTION | 065329 | ANDA | Sagent Pharmaceuticals | 25021-107-20 | 25 VIAL in 1 CARTON (25021-107-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | 2009-11-05 |
| Acs Dobfar | CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INJECTION | 065329 | ANDA | WG Critical Care, LLC | 44567-700-25 | 25 VIAL in 1 CARTON (44567-700-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | 2008-07-24 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Ceftriaxone Suppliers: Manufacturing and Supply Landscape
Who supplies ceftriaxone to the market?
Ceftriaxone is supplied globally by manufacturers of active pharmaceutical ingredient (API) and by finished-dose (FDF) producers that package tablets, vials, or injectables. Supply is typically structured around:
- API manufacturers (ceftriaxone sodium for injection/sterile products)
- Finished-dose sterile injectables (vials/powders for IV/IM use)
- Contract manufacturers that produce vials under branded or distributor labels
Which companies are documented suppliers (API and/or finished doses)?
The following manufacturers are consistently identified as ceftriaxone suppliers through regulatory listings and commercial sourcing documentation. (Where a company is referenced for API and/or FDF varies by jurisdiction and listing.)
Major global suppliers of ceftriaxone (API and/or finished dosage)
| Company | Coverage | Notes on market presence |
|---|---|---|
| Hetero Drugs | FDF and/or supply networks (varies by site) | Large-scale injectable manufacturer in India; frequent presence across emerging markets |
| Sun Pharmaceutical Industries | FDF and/or supply networks | Broad sterile and hospital-portfolio footprint |
| Cipla | FDF | Hospital injectable portfolio includes cephalosporins |
| Mylan / Viatris | FDF | Global generic injectable supply |
| Sandoz | FDF | Established generic injectable business |
| Siegfried | CDMO | Sterile and complex injectable manufacturing capacity (site-dependent) |
| Lupin | FDF and supply | Injectable portfolio and distribution footprint |
| Dr. Reddy’s Laboratories | FDF | Sterile injectables portfolio across markets |
| Amneal Pharmaceuticals | FDF | Generic injectable supplier in the US and other markets |
| Teva | FDF | Broad generic injectable supply network |
| B. Braun | FDF/distribution | Injectable supply presence in multiple regions |
| Fresenius Kabi | FDF | Hospital injectable supply presence (site- and product-line dependent) |
Common API supplier profiles
Ceftriaxone API is often supplied by:
- Indian and Chinese API producers (bulk API and intermediates)
- Specialty cephalosporin API manufacturers that support sterile cephalosporin development and scale-up
In practice, many downstream distributors source from a smaller number of API plants and then qualify multiple FDF manufacturing sites to maintain continuity of supply.
What dosing forms and packaging do suppliers typically offer?
Ceftriaxone is primarily marketed as:
- Powder for injection (reconstitutable vials)
- Strengths commonly used in hospital formularies include 1 g and 2 g presentations
- Many suppliers provide ceftriaxone sodium for IV or IM administration
Supplier packaging differs by geography:
- Single-dose vials in cartons
- Multi-pack presentations in distributor formats
- Label formats in local languages with lot tracking for cold-chain-independent storage
How procurement teams should screen suppliers
Given ceftriaxone is used widely and production is concentrated, procurement typically screens suppliers using:
- Regulatory status for the target market (local dossier approval and manufacturing authorization)
- Sterility assurance and injectable compliance for FDF producers
- API DMF or equivalent status (where applicable) and supply chain traceability
- Batch release and stability documentation aligned to local distribution
- Continuity capacity (multiple FDF sites and redundant API sources)
What regions show the most supplier depth?
Supply depth is typically highest where:
- Government procurement systems run large hospital tenders for antibiotics
- There is dense generic manufacturing activity
- API and sterile fill-finish operations are colocated or available via CDMO networks
That usually maps to:
- India and China for API and cost-competitive FDF supply
- Europe and North America for compliance-driven, dossier-heavy generic injectable supply
- MENA, Africa, and Latin America for distributor-rich sourcing with multiple equivalent brands
What are the practical procurement options?
Procurement typically routes through one of three channels:
- Direct FDF purchase from global generics
- Best for hospitals and regulated distributors requiring predictable lead times
- Distributor procurement with multi-brand substitution
- Best where tender rules allow equivalent ceftriaxone sodium presentations
- CDMO or co-manufactured supply
- Best for manufacturers building national dossiers or launching in new markets
Which suppliers are most likely to meet high-volume tender needs?
In ceftriaxone, high-volume procurement tends to favor suppliers that can sustain:
- consistent vial availability (1 g and 2 g),
- multiple batch releases per month,
- and regional storage/distribution contracts.
This usually concentrates supply among large generic injectable players and established sterile CDMOs.
Key risk flags in ceftriaxone sourcing
Procurement often tightens controls on:
- Single-source API dependency (risk of API plant downtime)
- Sterile manufacturing site changes without sufficient comparability data
- Variant salt forms (ceftriaxone sodium vs equivalents) not matching local pharmacopeial expectations
- Documentation gaps that delay batch release and regulatory updates
Key Takeaways
- Ceftriaxone is supplied through two parallel tracks: API producers and finished-dose sterile vial manufacturers.
- Global supply is dominated by large generic injectable companies and sterile-capable CDMOs, with India and China as core API supply geographies.
- Tender reliability depends less on brand count and more on batch release cadence, dossier/regulatory fit, and redundant API sourcing.
- Procurement should screen suppliers for injectable manufacturing authorization, batch release documentation, and continuity capacity.
FAQs
1) Do suppliers for ceftriaxone primarily provide API or finished vials?
Both. Many suppliers sell finished-dose sterile injectables, while others specialize in ceftriaxone API used by downstream manufacturers.
2) What strength and form dominate hospital procurement?
The dominant hospital formats are reconstitutable vials supplied as powder for injection, commonly in 1 g and 2 g strengths.
3) Which supplier type is best for uninterrupted tender supply?
Large FDF manufacturers with multiple batch release streams and supplier redundancy for API continuity typically perform best in high-volume procurement.
4) Can brands be substituted across countries for ceftriaxone?
Substitution is possible when formulations match the required ceftriaxone salt, strength, and vial presentation, and when local regulatory equivalence rules are met.
5) What due diligence matters most when buying ceftriaxone?
Focus on regulatory status in the destination market, sterility/injectable compliance, batch release records, stability documentation, and API supply redundancy.
References
[1] European Medicines Agency. (n.d.). Human medicines: EPARs and related information. https://www.ema.europa.eu
[2] U.S. Food and Drug Administration. (n.d.). Drugs@FDA database. https://www.accessdata.fda.gov/scripts/cder/daf/
[3] World Health Organization. (n.d.). WHO essential medicines list and antibiotic guidance materials. https://www.who.int/health-topics/antimicrobial-resistance-and-stewardship
[4] Uppsala Monitoring Centre. (n.d.). WHO global pharmacovigilance database. https://www.who-umc.org/
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