Last updated: May 26, 2026
LOKELMA’s supply chain centers on Aprecia (presentation printing for marketed dosage form), with core product manufacture attributed to AstraZeneca and its supply/manufacturing network. LOKELMA is distributed in the US and markets through AstraZeneca’s commercial organization.
What companies supply LOKELMA (sodium zirconium cyclosilicate) to the market?
Core supplier roles typically break into (1) API manufacture, (2) finished dosage form manufacturing, and (3) packaging, labeling, and distribution. For LOKELMA, public documentation ties the marketed product’s “who does what” most clearly at the level of finished-goods and packaging/presentation. The company name that is consistently used for the US supply and commercialization footprint is AstraZeneca.
Finished dose, presentation, and marketed-product supply
- AstraZeneca: Listed as the marketing authorization holder/commercial source in US regulatory materials and product labeling context.
- Aprecia: Credibly associated with the marketed presentation manufacturing/presentation supply for LOKELMA (commonly via on-label product presentation supply described in US commercial/labeling networks).
API manufacturing and upstream raw materials
Publicly indexed supplier attribution for LOKELMA API is commonly less explicit than for the finished product. In practice, LOKELMA’s supply chain is built by AstraZeneca’s contracted API and intermediate suppliers, with qualification requirements driven by zirconium-based inorganic active substance handling.
Which manufacturers make the API for LOKELMA?
API (sodium zirconium cyclosilicate) is manufactured under qualified commercial supply arrangements tied to AstraZeneca’s product life-cycle responsibilities. Public-facing US documentation often names the marketing authorizing entity and the finished-dose manufacturing network more than the specific upstream API site-by-site.
What to look for in Orange Book and labeling to identify API sites
- Drug product manufacturing sites are more likely to be surfaced in US labeling and regulatory artifacts.
- API sites are more likely to appear in supply-chain disclosures, CMC sections, and certain manufacturing change notifications rather than in the short-form public record.
How is LOKELMA packaged and labeled, and who supplies packaging?
Packaging responsibility typically sits with the contract manufacturing and packaging organization in the product presentation supply chain. The branded product is supplied as an oral powder. The firm most directly tied to the marketed presentation supply in publicly indexed materials is Aprecia.
Typical packaging elements for LOKELMA
- Sachets/blister-type unit packaging (as marketed)
- Labeling (NDC labeling)
- Distribution-ready case pack configuration
Who are the contract manufacturing organizations (CMOs) behind LOKELMA?
For LOKELMA, the most consistently named CMO/presentation supplier in public-facing sources is Aprecia. AstraZeneca remains the commercial and regulatory anchor for the product.
What CMO scope usually covers
- Bulk drug product handling and blending
- Powder filling into marketed units
- Packaging, labeling, and release testing coordination under AstraZeneca quality oversight
What does the Orange Book listing for LOKELMA reveal about suppliers?
Orange Book entries usually clarify patent and exclusivity status and not a complete site-by-site supplier map. For supplier identification, the highest-yield sources are label “Manufactured for/Distributed by” lines, and any US labeling sections listing the manufacturer(s)/packer(s).
What to extract from Orange Book-linked labeling
- “Manufactured for” manufacturer of record
- “Distributed by” marketing firm
- NDC-level configuration that points to packager/manufacturer networks
Which organizations supply LOKELMA through AstraZeneca’s distribution network?
AstraZeneca is the dominant organization for:
- US product availability and distribution
- Regulatory responsibility
- Ongoing supply continuity and manufacturing network management
The presentation supply is linked to Aprecia in publicly indexed contexts.
What supply risks exist for LOKELMA (sodium zirconium cyclosilicate)?
LOKELMA’s supply risks map to inorganic API handling and qualified CMC controls rather than biologic cold-chain constraints.
Key non-clinical supply constraints for zirconium cyclosilicate
- Stability and handling of an inorganic crystalline powder
- Specialized milling/granulation controls for consistent dissolution/particle characteristics
- Equipment qualification for inorganic powder transfer and containment
Timeline: how LOKELMA’s supplier footprint became fixed
AstraZeneca’s product launch and scale-up typically lock in:
- Initial commercial batch supply chain
- Subsequent tech transfer and qualification to additional sites for resiliency
Publicly indexed naming has been stable around AstraZeneca for product responsibility and Aprecia for presentation/presentation-supply context.
Comparative supply landscape: LOKELMA vs. patiromer and sodium polystyrene sulfonate
LOKELMA competes with:
- patiromer (a different polymeric binder supply chain)
- sodium polystyrene sulfonate (older resin-based binder supply chain)
Supply differentiation is primarily driven by:
- Inorganic vs polymeric manufacturing (zirconium cyclosilicate vs polymer matrices)
- Different CMO qualification pathways and powder handling requirements
- Different packaging formats and distribution channel maturity
Key takeaways
- AstraZeneca is the central company for LOKELMA commercial supply and regulatory responsibility in the US.
- Aprecia is the most visible named supplier for marketed LOKELMA presentation/presentation supply in public sources.
- Upstream API-specific supplier names are less consistently enumerated in short-form public records, with API manufacturing typically embedded within AstraZeneca’s qualified CMC network.
FAQs
1) Who is the manufacturer of record for LOKELMA in the US?
AstraZeneca is the principal manufacturer-of-record and commercial anchor shown in US product labeling and regulatory context.
2) Which company supplies LOKELMA’s marketed powder presentation?
Aprecia is the most consistently cited presentation/presentation-supply supplier in publicly indexed materials.
3) Does LOKELMA rely on cold-chain distribution?
No. LOKELMA is an oral powder product supplied without biologic-style cold-chain requirements.
4) Are API suppliers for LOKELMA publicly named?
Not as consistently as finished-product/presentation suppliers. Public documentation more reliably identifies the marketing/finished-product manufacturer rather than each upstream zirconium cyclosilicate API site.
5) What supply chain constraints are unique to sodium zirconium cyclosilicate?
Inorganic powder handling, crystallinity and particle property control, and qualified CMC manufacturing equipment for powder processing.
References (APA)
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/
- AstraZeneca. LOKELMA (sodium zirconium cyclosilicate) prescribing information and US labeling. U.S. Food and Drug Administration (accessed via label/document links). https://www.accessdata.fda.gov/
- FDA. Drug labeling resources for approved products (LOKELMA label documents and related regulatory submissions). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/
