Last updated: May 29, 2026
Calcium chloride 10% for injection is supplied by multiple global sterile injectables companies, with product sourcing typically handled through major distributors and contract manufacturing networks. Key supply chains include U.S.-listed sterile injectables makers (for “calcium chloride injection, USP, 10%”) and global sterile manufacturers feeding FDA market via NDA/ANDA holders and distributors.
What companies supply calcium chloride 10% injection in the US?
Core answer: Calcium chloride 10% injection is distributed by large pharmaceutical wholesalers and supplied by sterile injectables manufacturers that file and maintain FDA product listings for “calcium chloride injection, USP, 10%.”
Typical US distribution routes
- National pharmaceutical wholesalers (prime and secondary)
- GPO channels used by hospitals and infusion centers
- Direct purchasing by health systems from authorized distributors
- Cold-chain and sterile storage compliant logistics (where applicable)
Which FDA-listed manufacturers commonly produce calcium chloride 10%?
Answer: Calcium chloride injection is produced by multiple sterile injectables companies; the exact “10%” presentation depends on the registered product label strength and container configuration (e.g., 10% w/v calcium chloride dihydrate equivalent).
Manufacturer and label-claim variability that affects “who supplies”
- Strength stated as “10%” on label
- Container size (mL per vial/ampul or per bag for diluted use)
- Salt form (commonly calcium chloride dihydrate in the injection)
- Packaging presentation (vial vs. ampul) and latex-free options
What is the Orange Book status of calcium chloride 10%?
Core answer: Calcium chloride injection is generally not an NDA/505(b)(1) branded drug with a conventional Orange Book exclusivity life cycle like new molecular entities; many listings are older “USP/compendial” products. Orange Book protections, when present, relate to specific approved applications or listed patents tied to a formulation, manufacturing, or method, not to the active ingredient alone.
Do patent listings block generic calcium chloride 10%?
Answer: For older compendial injectables, barriers are usually practical and regulatory (sterile manufacturing capacity, CGMP compliance, and labeling/packaging) rather than broad active-ingredient exclusivity.
Which distributors sell calcium chloride 10% injection to hospitals and pharmacies?
Core answer: Hospital procurement for calcium chloride 10% injection is routed through major pharmaceutical distributors and group purchasing organizations.
Typical distributor buckets
- National wholesalers covering hospital accounts and emergency replenishment
- GPO-contracted channels
- Specialty distributors for sterile injectables and shortage mitigation
How do you source calcium chloride 10% during shortages?
Core answer: Shortage mitigation for calcium chloride 10% depends on reallocating authorized product across wholesalers, qualifying alternates, and switching between labeled presentations only when therapeutically equivalent.
What sourcing constraints matter most?
- Authorized distributor only (to avoid counterfeit/gray-market risk)
- Sterility and lot release documentation availability
- Container equivalence: concentration, total deliverable volume, and administration compatibility
- Lead-time from manufacturer to distribution center
- Labeling match to institutional pharmacy protocols
What formulations and presentations exist for calcium chloride 10%?
Core answer: “Calcium chloride 10% injection” is primarily a strength specification; product form varies by container and sometimes excipient composition.
Common presentation patterns
- Single-dose vials
- Ampuls
- Label sizes vary by mL or total calcium chloride mass
- Packaging may be natural rubber-free depending on supply
How do you evaluate contract manufacturing for calcium chloride 10%?
Core answer: Contract manufacturing for sterile injectables is typically assessed via FDA facility listings, sterile aseptic processing capabilities, and product transfer history for compounded or repackaged presentations (only under appropriate regulatory frameworks).
What manufacturing/IP barriers affect supply?
- Aseptic fill-finish capacity and contamination control track record
- Container closure system qualification
- Regulatory inspection outcomes and batch release timelines
- Documentation for USP compliance and labeling audits
- Validation of line clearances across strengths (10% vs other concentrations)
Key Takeaways
- Calcium chloride 10% injection is supplied by multiple sterile injectables manufacturers and distributed through major pharmaceutical wholesalers and GPO channels.
- Orange Book listings, when present, typically do not create broad active-ingredient exclusivity; supply risk is more often driven by sterile manufacturing capacity and regulatory readiness.
- Shortage sourcing is managed through authorized redistribution, presentation equivalence, and fast switchovers constrained by CGMP lot release and hospital protocol alignment.
FAQs
1) Who makes calcium chloride 10% injection in the US?
Multiple FDA-listed sterile injectables manufacturers supply “calcium chloride injection, USP, 10%,” with exact makers varying by container type and label presentation.
2) Are there generic versions of calcium chloride 10%?
Yes. Most market offerings are generic/compendial versions unless a specific approved application is tied to listed patents.
3) Can hospitals substitute calcium chloride 10% presentations?
Substitution depends on concentration match (10%), container equivalence, and excipient compatibility per pharmacy policy and administration compatibility.
4) What distributors typically carry calcium chloride 10%?
National pharmaceutical wholesalers and GPO-contracted channels commonly carry authorized calcium chloride 10% injection.
5) What causes calcium chloride 10% shortages?
Aseptic sterile fill-finish constraints, CGMP batch failures or inspection outcomes, container closure supply limits, and allocation during manufacturing downtime are typical drivers.
References
No sources were provided in the prompt.
