Last updated: June 5, 2026
SIGNIFOR LAR KIT (pasireotide long-acting injection) is a branded depot product supplied through a controlled manufacturing and packaging network. The commercial “kit” is assembled from drug product plus associated components used for administration. The supplier landscape is defined by the companies holding manufacturing responsibility for (1) the pasireotide depot drug product and (2) the packaged kit components.
Who supplies SIGNIFOR LAR KIT drug product (pasireotide depot) and who supplies the kit components?
Answer: The SIGNIFOR LAR KIT supply chain centers on the drug-product manufacturer for pasireotide long-acting injection and the company responsible for final kit assembly/packaging. The kit is not a standalone commodity item; it is a branded configuration of the depot drug product and administration components distributed under the marketing authorization holder’s label.
Drug-product manufacturing roles
Key supplier responsibilities for SIGNIFOR LAR KIT are typically segmented into:
- Depot drug substance-to-drug-product manufacturing: sterile manufacturing, aseptic processing (as applicable), formulation fill-finish for long-acting pasireotide depot.
- Long-acting parenteral packaging: controlled assembly of the depot syringe/vial components into the branded configuration that becomes the commercial “kit.”
Kit component supply roles
“Kit” supply usually includes:
- Administration components (for preparation and injection)
- Ancillary devices required for reconstitution or mixing (if applicable to the specific presentation)
- Outer packaging and labeling elements tied to FDA labeling
What companies are listed as manufacturers/suppliers for SIGNIFOR LAR KIT in FDA labeling and application materials?
Answer: The companies named in FDA labeling as the manufacturer, packager, or distributor for SIGNIFOR LAR (pasireotide) and the kit components define the legally relevant supplier set for supply-chain due diligence.
Where supplier names appear
For branded prescription products like SIGNIFOR LAR:
- The Highlights of Prescribing Information and Medication Guide/package insert commonly identify the manufacturer and/or distributed by entity.
- The package/labeling (carton and immediate container) typically lists manufacturing site and packager roles.
- The FDA application and submission modules used for manufacturing changes typically identify contract manufacturing organizations (CMOs) and packaging sites, but the supplier names that matter for “kit suppliers” are the ones tied to commercial labeling and current Good Manufacturing Practice (cGMP) listings.
Who is the marketing authorization holder for SIGNIFOR LAR and how does that map to suppliers?
Answer: The marketing authorization holder (and label holder) typically governs the supplier network through quality agreements and batch release responsibilities. Kit “supplier” inquiries in practice track back to:
- the label holder (commercial responsibility)
- the drug-product manufacturer (batch manufacture)
- the packager/final assembler for the kit configuration
Practical mapping for licensing and procurement
- For sourcing alternatives, the critical question is not the “kit” supplier alone.
- The actionable supplier set is: depot manufacturing site(s) plus final packaging/kit assembly site(s), because substitutes must match both composition and device/handling requirements.
What are the key supplier risk points for SIGNIFOR LAR KIT procurement?
Answer: Depot injectables create supplier constraints around sterile manufacturing, long-acting formulation controls, and packaging configuration integrity.
Depot manufacturing and release constraints
Risk points that affect supplier qualification:
- specialized sterile manufacturing capability for long-acting injectable depots
- tight control of particle properties, viscosity, and reconstitution/mixing performance
- release testing capacity for sterility and depot-specific quality attributes
- change-management burden for formulation or device/kit configuration
Kit assembly and administration compatibility
Risk points:
- component interchangeability (syringe/vial/adapter compatibility)
- device performance (handling, locking, injection pathway)
- label and lot traceability requirements for batch-level compliance
How do SIGNIFOR LAR KIT suppliers compare with other pasireotide depot supply chains?
Answer: Other depot analogs face similar constraints, but the relevant supplier comparison depends on whether manufacturing and kit assembly are handled by the same CMO network. Supplier overlap is often limited because long-acting injectables are tightly controlled at formulation and aseptic fill-finish sites.
Competitive supply-chain pattern
In the branded long-acting injectable market, the typical structure is:
- one primary depot drug-product manufacturer
- one or two CMO packaging/kit assembly partners
- regional distributors under the label holder
What supplier changes or manufacturing transfers typically affect SIGNIFOR LAR KIT availability?
Answer: Availability risk usually tracks to depot drug-product site changes, packaging configuration changes, or contract manufacturing capacity constraints.
Triggers in depot injectable supply
- cGMP inspections tied to sterile manufacturing performance
- capacity reallocation for parallel programs at the same CMO
- changes to kit components or primary container closure systems
- formulation or process change requiring comparability and FDA notification
Key Takeaways
- SIGNIFOR LAR KIT procurement depends on two supplier layers: (1) pasireotide long-acting depot drug-product manufacturing and (2) final kit packaging/assembly of the labeled administration configuration.
- “Kit supplier” questions should be resolved through the current FDA labeling/label holder supply chain and the commercially released kit configuration rather than generic component sourcing.
- Supplier risk is concentrated in depot sterile manufacturing, depot quality attributes, and kit configuration integrity.
FAQs
- Who makes pasireotide long-acting injection used in SIGNIFOR LAR KIT?
- Which companies package and assemble SIGNIFOR LAR KIT for distribution?
- What cGMP sites are most relevant for SIGNIFOR LAR KIT batch release?
- Can kit components be sourced interchangeably without regulatory impact for SIGNIFOR LAR?
- What manufacturing changes most often disrupt supply of long-acting depot injectables like SIGNIFOR LAR?
References (APA)
- U.S. Food and Drug Administration. (n.d.). Prescribing information and product labeling for SIGNIFOR LAR (pasireotide). FDA.
- U.S. Food and Drug Administration. (n.d.). Drug application and labeling records for pasireotide long-acting injection. FDA.
- EMA. (n.d.). Signifor LAR product information and manufacturing information. European Medicines Agency.
