Last updated: May 23, 2026
CefoTetan Disodium Suppliers: Who Manufactures and Supplies Cefotetan API and Finished Dosage Forms
CefoTetan disodium supply chains typically split into (1) active pharmaceutical ingredient (API) manufacturing and (2) finished-dose supply (injectable cephalosporins). A reliable supplier short-list depends on whether the target is US commercial finished product, API only, or contract manufacturing. No authoritative supplier list is provided here because the requested scope (“suppliers for Cefotetan disodium”) requires live product/market verification (manufacturer names vary by geography, dosage strength, and regulatory status, and many cephalosporin listings are intermittent).
What companies supply cefotetan disodium API?
API supply for cefotetan disodium is concentrated among specialty generics and cephalosporin API manufacturers. Supplier identification is normally derived from:
- FDA Drug Master File (DMF) references for cefotetan-related filings
- API importers and labeled distributors on commercial product labels
- Corporate supply/contract manufacturing disclosures in regulatory submissions
Which firms supply cefotetan disodium injection in the US?
In the US, cephalosporin injectable supply is routed through holders of approved NDA/ANDA products, then through wholesalers and specialty distributors. Supplier identification requires mapping:
- FDA-approved product holders
- NDC labelers and their manufacturing sites
- Current market availability by strength and package size
How does cefotetan disodium compare with other injectable cephalosporins by supply risk?
Cefotetan disodium supply risk tracks with:
- narrow-margin sterile manufacturing capacity
- dependence on a limited number of beta-lactam intermediates
- intermittent commercial manufacturing runs
Compared with higher-demand cephalosporins, cefotetan’s sourcing is more likely to be irregular where demand is lower.
What is the Orange Book status of cefotetan disodium and how does it affect supplier choices?
If an FDA reference product is discontinued or withdrawn, the supply landscape shifts from Orange Book exclusivity-driven competition to distribution continuity and contract manufacturing availability. Orange Book status also affects whether generics can legally supply finished product in parallel.
Which DMFs or manufacturing authorizations typically cover cefotetan disodium?
For API-only procurement, the practical supplier set is usually limited to entities with:
- Drug Master File coverage (or API master batch import capabilities)
- validated cefotetan disodium synthetic routes and sterile-grade impurity controls
What contract manufacturing options exist for cefotetan disodium injectable?
Sterile cephalosporin CMOs can support:
- vial or syringe presentations
- lyophilized versus liquid fills (route depends on formulation constraints)
- terminal sterilization method compatibility
Contract manufacturing availability depends on whether the formulation is reconstitutable or ready-to-use, and whether the facility already runs beta-lactam sterilization workflows.
What formulation and manufacturing/IP barriers affect cefotetan disodium supply?
Supply constraints often come from:
- beta-lactam degradation control in manufacturing and hold times
- impurity profile targets tied to approved specifications
- process validation requirements for aseptic/terminal sterilization
What generic entry risks exist for cefotetan disodium injectable?
Generic entry is typically blocked by:
- reference product discontinuation or lack of active FDA approval for a given strength
- facility sterilization capability constraints
- limited market pull that discourages new approvals
How can procurement teams verify cefotetan disodium suppliers?
Verification usually uses:
- FDA labeling and NDC directories for the finished-dose supplier identity
- DMF-linked API manufacturer verification via regulatory submissions
- GMP certificate checks for beta-lactam manufacturing sites
- CoA trend review for cefotetan-related impurities and potency
Key Takeaways
- Cefotetan disodium supply is best analyzed by separating API manufacturers from finished-dose labelers/distributors.
- Accurate supplier lists require mapping to FDA approvals, NDC labelers, and DMF-linked API sources.
- Cephalosporin sterile manufacturing capacity and beta-lactam process constraints are primary drivers of supply availability.
FAQs
- Who are the FDA-listed manufacturers for cefotetan disodium injection (by NDC)?
- Which companies hold or reference DMFs for cefotetan disodium API?
- Is cefotetan disodium available as a generic injectable in the US, and who supplies it?
- What documentation is required to qualify a cefotetan disodium API supplier (CoA, DMF, GMP)?
- Does cefotetan disodium injection have formulation-specific supply constraints (lyophilized vs liquid)?
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
- FDA National Drug Code (NDC) Directory. U.S. Food and Drug Administration.
