Last updated: June 3, 2026
Executive summary: Cefoxitin supply is concentrated in a small set of branded-generic manufacturers that make injectable cefoxitin sodium in US-registered facilities. The practical supplier set for hospital purchasing and wholesaler distribution is determined by (1) which label holders list cefoxitin on the FDA Orange Book, (2) which NDA/ANDA holders currently have product in distribution, and (3) whether any shortages or FDA-enforced manufacturing holds constrain specific strengths (e.g., 1 g, 2 g) and containers (vials).
If a complete supplier list by company and strength is required for RFPs, purchasing, or contracting, it must be built from the latest FDA “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book) entries for cefoxitin sodium and the associated labelers/manufacturing sites listed for each product, plus current drug shortage notifications.
Which companies supply cefoxitin (cefoxitin sodium) injections in the US?
Direct answer: The US supplier set is the set of Orange Book labelers/manufacturers currently approved for cefoxitin sodium injection and actively distributed through wholesalers. Orange Book entries identify the approved product, labeler, application type (NDA/ANDA), and listed manufacturers for that label.
What suppliers appear as labelers on the Orange Book for cefoxitin injection?
Orange Book listings for cefoxitin sodium injection determine the baseline supplier roster:
- Labeler/Applicant (drug product owner of record)
- Application type (NDA vs ANDA)
- Dosage form and strength (commonly vial strengths for injectable cefoxitin)
- TE code and reference product linkage (when applicable)
- Manufacturing and packaging site(s) listed for the approved product
How to map labelers to actual manufacturing sites
For procurement and regulatory risk screening, a supplier comparison must distinguish:
- Label holder (who owns the approved application and labeling)
- Manufacturing site (who makes the sterile drug product or intermediates)
- Packaging site (if separated)
- Sterile fill-finish dependency (critical for cephalosporin sterile injectables)
What patents or exclusivity affect cefoxitin supply and approved generics?
Direct answer: Cefoxitin is an older antibiotic with a mature approval landscape, so supplier count is driven more by manufacturing capacity, sterile drug compliance, and shortage events than by active exclusivity for many product formats.
How patent estate influences the number of approved ANDAs
For older small-molecule antibiotics:
- Initial patents typically expired years ago.
- Later product-specific protections (e.g., manufacturing process or formulation for injection) can still limit direct generic entry for some presentations, but sterile injectable products usually converge quickly to multiple competitors.
Where to check instead of patents: Orange Book and Drug Shortages
Procurement-relevant constraints are usually:
- FDA manufacturing observations
- Sterile facility shutdowns or remediation timelines
- Temporary distribution holds
- Shortage designations that restrict supply by labeler and strength
What FDA status and Orange Book listings apply to cefoxitin injection?
Direct answer: Current sourcing requires verifying the latest Orange Book “Drug Product” status and whether specific strengths are listed as available, discontinued, withdrawn, or suspended.
What “Orange Book status” fields change supplier availability?
When evaluating cefoxitin suppliers, the fields that track availability are:
- Approval status (active vs withdrawn/discontinued)
- Application type (NDA vs ANDA)
- Dosage form/strength coverage
- Labeler identity (who you contract with)
- Manufacturers listed (where supply is actually produced)
How to use Orange Book data for RFP qualification
A contract-ready supplier shortlist should include only those whose cefoxitin product:
- remains approved and not withdrawn, and
- is listed with manufacturing/packaging sites capable of meeting the required strength and container needs.
How many cefoxitin generic suppliers exist, and why does the count fluctuate?
Direct answer: The number of suppliers for cefoxitin injection tends to fluctuate with sterile manufacturing throughput and regulatory capacity, not with a steady wave of new entries.
Key drivers of supplier churn in sterile antibiotics
Cefoxitin supply typically tightens when:
- a key sterile fill-finish line is suspended,
- a facility changes aseptic workflow or undergoes FDA remediation,
- raw material supply tightens for cephalosporin intermediates,
- a shortage forces distribution controls by wholesaler.
Which cefoxitin strengths and presentations have the highest supply-risk?
Direct answer: Supply risk is usually concentrated in the strengths and container configurations that rely on fewer fill-finish runs.
Strength-by-strength risk logic
When building a supplier risk matrix:
- rank strengths by historical shortage duration,
- map each strength to the number of Orange Book labelers currently active,
- flag strengths with one or two remaining labelers.
What generic entry risks exist for cefoxitin injectable products?
Direct answer: For cefoxitin, generic entry risk is tied to:
- sterile manufacturing and aseptic validation capacity,
- stability data for the specific vial/solvent system,
- ability to demonstrate bioequivalence/clinical equivalence where required (for injectable generics, documentation focus can shift toward chemistry, manufacturing, controls, and analytical bridging).
What prevents new cefoxitin suppliers from scaling quickly
Common blockers for sterile injectables:
- limited aseptic production slots,
- inspection timing and remediation delays,
- batch size constraints for vial production.
What manufacturing/IP barriers matter most for cefoxitin suppliers?
Direct answer: For established cefoxitin injectables, operational manufacturing and regulatory barriers are usually more decisive than IP barriers.
Primary supply-chain choke points
- sterile fill-finish availability for injectable beta-lactams
- QC release capacity for parenterals
- stability and container-closure compatibility testing throughput
How do cefoxitin suppliers compare on compliance, inspection outcomes, and quality signals?
Direct answer: Procurement qualification should prioritize:
- inspection history for the listed manufacturing sites,
- batch release timelines,
- contamination/sterility incident history,
- ability to maintain consistent potency and appearance specifications.
What to screen in supplier due diligence
For each labeler/manufacturing site on the Orange Book:
- sterility assurance program maturity
- deviation and CAPA volume trends
- last inspection classification for aseptic processing
- on-time batch release performance
What does the FDA drug shortage picture imply for cefoxitin supplier selection?
Direct answer: When FDA lists cefoxitin as in shortage or constrained supply, the purchasing decision shifts to:
- companies whose product remains continuously distributed,
- suppliers with multiple active lots across strengths,
- labelers with redundant manufacturing sites.
How hospitals should use shortage information
- switch to alternate strengths only when therapeutically acceptable and supply permits,
- prioritize labelers with confirmed distribution continuity,
- keep safety stock where feasible due to volatile sterile production constraints.
Key Takeaways
- Cefoxitin supplier identity in the US is determined by Orange Book labelers and their listed manufacturing sites for cefoxitin sodium injection.
- Supplier count and availability fluctuate mainly due to sterile manufacturing capacity and regulatory events, not active IP constraints.
- The procurement-ready supplier list must be constructed from current Orange Book active listings and cross-checked with FDA shortage status by strength and presentation.
- For contracting and litigation-proof sourcing, distinguish label holder vs actual manufacturing site and qualify based on inspection and batch-release performance.
FAQs
1) How do I identify the current labelers for cefoxitin injection?
Use the FDA Orange Book entry for cefoxitin sodium injection to extract the labeler/applicant and listed manufacturers by strength.
2) Which cefoxitin strengths are most likely to face shortages?
The highest risk is typically the strength with the fewest active labelers and the smallest number of functioning sterile fill-finish slots.
3) Are cefoxitin suppliers interchangeable across vial sizes?
Not always. Even for the same active ingredient, vial size and presentation can differ by manufacturing site, stability window, and release controls.
4) What regulatory signals predict cefoxitin supply disruption?
FDA inspection outcomes for sterile facilities, FDA shortage notifications, and distribution holds tied to batch release issues.
5) What is the fastest way to switch cefoxitin suppliers during a shortage?
Select alternative Orange Book labelers with active approval and confirmed distribution for the required strength, then validate lot-specific release timelines and expiration/shelf-life.
References (APA)
- FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/
- FDA. (n.d.). Drug Shortages. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/drugshortages/
