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Suppliers and packagers for generic pharmaceutical drug: pasireotide diaspartate
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pasireotide diaspartate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677 | NDA | Recordati Rare Diseases, Inc. | 55292-131-60 | 60 PACKAGE in 1 BOX (55292-131-60) / 6 AMPULE in 1 PACKAGE (55292-131-06) / 1 mL in 1 AMPULE (55292-131-01) | 2012-12-14 |
| Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677 | NDA | Recordati Rare Diseases, Inc. | 55292-132-60 | 60 PACKAGE in 1 BOX (55292-132-60) / 6 AMPULE in 1 PACKAGE (55292-132-06) / 1 mL in 1 AMPULE (55292-132-01) | 2012-12-14 |
| Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677 | NDA | Recordati Rare Diseases, Inc. | 55292-133-60 | 60 PACKAGE in 1 BOX (55292-133-60) / 6 AMPULE in 1 PACKAGE (55292-133-06) / 1 mL in 1 AMPULE (55292-133-01) | 2012-12-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: pasireotide diaspartate
Suppliers for Pasireotide Diaspartate (Signifor/Signifor LAR): Who Manufactures the Active, Drug Product, and Key Components?
Executive summary: Public-facing supplier visibility for pasireotide diaspartate is split between (1) contract manufacturing for drug substance and drug product across jurisdictions and (2) upstream sourcing of peptide raw materials (notably protected amino acids, coupling reagents, and PEG/solvent systems depending on the route), with the clearest footprints tied to Novartis’ commercial manufacturing network for Signifor (pasireotide diaspartate) and Signifor LAR (pasireotide pamoate for the LAR depot). Signifor LAR is not the diaspartate salt at the depot stage; the depot drug product uses pasireotide pamoate. Supplier diligence must therefore separate diaspartate (oral/solution product) from pamoate (LAR depot) when mapping outsourcing targets.
Who supplies pasireotide diaspartate API and drug product for Signifor?
Short answer: The primary supplier chain is anchored by Novartis for commercial supply of Signifor (pasireotide diaspartate), with reliance on contract manufacturing organizations (CMOs) for specific steps (peptide synthesis, isolation, finishing, sterile fill-finish, and packaging) depending on site capacity and lifecycle phase. Public “name-by-name” supplier listings are limited because peptide manufacturing networks are typically disclosed via regulatory filings, facility listings, and procurement relationships, not via product labeling.
API manufacturing: what “supplier” scope usually covers
For pasireotide diaspartate, “API supplier” diligence normally includes:
- Peptide synthesis contractor or in-house operation (protected amino acid coupling, resin processing, deprotection, cyclization/correct folding depending on process)
- Salt formation to yield diaspartate (or converting an intermediate to diaspartate form, then milling/crystallization controls)
- Polishing steps (filtration, centrifugation, drying, particle size specification)
- Analytical release (HPLC/UPLC for peptide purity; MS and chromatographic impurity profiling)
Drug product manufacturing: what “supplier” scope usually covers
For Signifor (diaspartate) the drug product supply chain includes:
- Aseptic processing if the commercial presentation is a sterile solution (commercial formats are typically parenteral)
- Sterile fill-finish and container-closure system assembly
- Labeling and kit assembly for global distribution
What CMOs or contract manufacturers make pasireotide diaspartate?
Short answer: Pasireotide’s commercial supply is characterized by a multi-site manufacturer footprint tied to Novartis’ global peptide and sterile injectable network. Publicly indexable evidence for specific CMO names is often indirect (facility addresses tied to regulatory submissions, inspection databases, or procurement disclosures). As a result, supplier mapping for pasireotide diaspartate is generally built from:
- FDA and EMA inspection-facility records
- Manufacturer and site-of-manufacture listings in regulatory dossiers
- Third-party quality agreements for sterile peptide injectables
Practical supplier-identification approach used in procurement and litigation diligence: cross-reference the site(s) listed for the finished dosage form and the site(s) listed for the API in regulatory product listings, then link those sites to historically inspected entities in inspection databases.
Is pasireotide diaspartate the same as pasireotide pamoate for Signifor LAR?
Short answer: No. Signifor LAR is formulated as pasireotide pamoate in the long-acting depot, while Signifor uses pasireotide diaspartate (diaspartate salt for the immediate formulation). Supplier selection and IP mapping must treat these as distinct salt forms with different manufacturing and solid-state controls.
Supplier due diligence implication
- API supplier for diaspartate will not be interchangeable with API supplier for pamoate
- Depot formulation suppliers (LAR) are not interchangeable with diaspartate injection fill-finish suppliers
- Salt form drives different crystallization and impurity profiles, which also affects quality transfer and regulatory comparability
What patents and suppliers matter most for pasireotide diaspartate manufacturing?
Short answer: While supplier mapping is operational, the key constraint for third-party manufacturing is typically process and formulation IP, including:
- peptide synthesis process controls (intermediates, purification, and isolation)
- salt formation/crystallization methods
- finished dosage form manufacturing steps (especially for sterile injectables)
Where supplier and IP intersect
- A CMO may have capacity to synthesize peptides, but still be constrained by:
- process patents covering specific synthesis steps or impurity profiles
- salt formation patents for diaspartate
- depot formulation patents if the supplier also supports LAR pamoate
What is the Orange Book status for pasireotide diaspartate?
Short answer: No complete answer can be produced here without a specific US product identifier (NDA strength and dosage form) and its Orange Book listing record. Orange Book status must be read against the exact FDA product listing to determine whether any ANDA-related exclusivities or listed patents exist for the diaspartate salt product.
When does pasireotide diaspartate lose exclusivity in the US?
Short answer: No complete answer can be produced here without identifying the exact NDA number and product strength/formulation tied to pasireotide diaspartate. Exclusivity depends on:
- patent terms for the listed patents
- pediatric exclusivity (if any)
- any granted market exclusivity tied to approval date and supplements
What generic entry risks exist for pasireotide diaspartate based on supplier and IP barriers?
Short answer: For peptide injectable drugs like pasireotide, generic entry risk is driven by:
- difficulty achieving bioequivalent impurity profiles
- control of solid-state and salt specifications
- sterile injectable manufacturing comparability
- potential process and salt-formation IP barriers
Operationally, even where legal barriers clear, the supplier chain must manage:
- peptide synthesis yield and impurity reduction
- batch-to-batch consistency
- validated sterilization and fill-finish processes
Which companies supply pasireotide diaspartate drug product components (fill-finish, sterile injectables)?
Short answer: Component-level supplier names are typically not exposed at scale in public product labeling. The reliable path used by procurement teams is:
- identify site-of-manufacture for the commercial product form
- obtain the sterile manufacturing and packaging site identity
- then map that site to known CMO/operator partners for sterile fill-finish and packaging
For pasireotide diaspartate, the critical outsourced components in many networks include:
- sterile filtration and aseptic fill-finish capacity
- container-closure and syringe/kit assembly capability
- labeling and controlled inventory packaging
What sourcing strategy works best for pasireotide diaspartate procurement?
Short answer: Adopt a two-track sourcing strategy that separates:
- Diaspartate peptide API supply (peptide synthesis, salt formation, release testing)
- Diaspartate sterile drug product supply (formulation, sterile processing, fill-finish, packaging)
This prevents downstream delays caused by mismatch between:
- diaspartate versus pamoate salt capability
- peptidology facility readiness (impurity control and analytical methods)
- sterile injectable regulatory track record
Key Takeaways
- Pasireotide diaspartate supply is anchored by Novartis commercial manufacturing, with outsourcing commonly occurring at peptide and sterile injectable steps through contracted sites.
- Signifor LAR uses pasireotide pamoate, not diaspartate, so supplier and IP mapping must separate salt forms.
- Supplier diligence for pasireotide diaspartate should be built from site-of-manufacture listings in regulatory records and inspection history, because direct supplier-name lists are limited.
- Manufacturing risk for third parties is typically tied to peptide impurity control, salt formation, and sterile fill-finish comparability, not only to raw material availability.
FAQs
1) Who makes pasireotide diaspartate peptide synthesis batches for commercial supply?
Commercial supply is handled through Novartis’ network and select CMOs, with peptide synthesis and salt formation being the most common outsourcing choke points.
2) Can a pasireotide pamoate supplier also supply pasireotide diaspartate?
Not automatically. The salt form changes crystallization and specification controls, so regulatory and technical transfer is required.
3) What are the biggest procurement risks for pasireotide diaspartate API?
Peptide synthesis yield, impurity profile control, and diaspartate salt-state reproducibility.
4) Which operations create the longest lead times for pasireotide diaspartate?
Peptide manufacturing and analytics release, plus sterile fill-finish scheduling and kit/packaging readiness.
5) How should procurement teams structure quality agreements for pasireotide diaspartate?
Split agreements across API and sterile drug product operators, with explicit controls for impurity specifications, salt form confirmation, and aseptic/process validation evidence.
References
- Novartis product and manufacturing information (Signifor/Signifor LAR regulatory dossiers and product labeling).
- FDA and EMA facility listing and inspection record sources for sterile injectables and peptide API manufacturing sites.
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