Suppliers and packagers for ODOMZO

ODOMZO

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm	ODOMZO	sonidegib phosphate	CAPSULE;ORAL	205266	NDA	Sun Pharmaceutical Industries, Inc.	47335-303-15	30 CAPSULE in 1 BOTTLE (47335-303-15)	2017-09-21
Sun Pharm	ODOMZO	sonidegib phosphate	CAPSULE;ORAL	205266	NDA	Sun Pharmaceutical Industries, Inc.	47335-303-83	30 CAPSULE in 1 BOTTLE (47335-303-83)	2017-09-21

Suppliers and packagers for ODOMZO

Last updated: May 30, 2026

Odomzo (Sonidegib) Suppliers: API, Finished-Dose Manufacturers, and Supply Chain Constraints

Odomzo (sonidegib) is supplied in the US by Novartis under a branded Rx supply model. Published sourcing details for the sonidegib API and each finished-dose manufacturing site are not fully enumerated in the public record without an Orange Book package and current FDA CMC inspection outcomes tied to the specific NDA lot releases.

Who are the pharmaceutical suppliers for Odomzo (sonidegib) in the US?

Featured answer: Novartis is the branded product holder and supplier of Odomzo in the US.

Commercial supply chain structure (typical branded model)

• NDA holder / brand supplier: Novartis
• API and drug product supply: executed through contract manufacturing organizations (CMOs) and CMOs may change over time
• Distribution: US wholesaler channels under the brand’s distribution agreements

Key practical implication for sourcing

• For procurement, GPO/wholesale purchasing, and wholesaler allocations, the relevant “supplier” is typically the brand’s commercial entity (Novartis), not the upstream API site.

What manufacturing sites supply Odomzo capsules (sonidegib) and how is production structured?

Featured answer: Publicly indexed “site-level” supply data for Odomzo capsules is not reliably available in a complete form across all manufacturing stages.

What matters for supplier qualification

• Drug product (capsule) manufacturing site quality agreements and batch release testing
• API synthesis and polymorph control (sonidegib solid-state behavior impacts downstream performance)
• Cross-site comparability if manufacturing is transferred

Common CMC drivers that shift suppliers

• FDA inspection outcomes for sterility/cleanliness do not apply here (not a sterile product), but GMP system compliance, line readiness, and data integrity records still drive site use.
• Formulation or capsule fill work instructions can require site-specific qualification.

Which companies manufacture sonidegib API for Odomzo?

Featured answer: The identity of specific sonidegib API suppliers (by legal entity and site) is not fully specified in a single, comprehensive public dataset covering current supply.

How to interpret “API supplier” in practice

• For branded procurement, the controlling documents usually identify the NDA-controlled supplier list or master batch records, not always public-facing corporate names.
• API sourcing can be consolidated across global Novartis networks and may use specialized intermediates and proprietary steps.

What are the drug product manufacturers for Odomzo capsules (strengths, dosage form)?

Featured answer: Odomzo is formulated as oral capsules containing sonidegib. Capsule manufacturing is managed under Novartis’s NDA CMC system via selected manufacturers.

Dosage forms and strengths (for alignment of supplier discussions)

• Odomzo is sold as an oral capsule product; supplier qualification must match:
  • capsule strength
  • dissolution and dissolution profile controls
  • excipient grades and capsule shell suppliers

Is Odomzo supply constrained, and how does supplier capacity affect availability?

Featured answer: Availability risk is primarily tied to batch release timing and manufacturing capacity for the capsule and API supply chain.

Supplier-capacity risk channels

• API availability and raw material lead times for intermediates used in sonidegib synthesis
• capsule fill line downtime and packaging material constraints
• QA release delays when analytical method validation or stability pulls are in progress

What is the Orange Book status of Odomzo, and does it affect supplier eligibility?

Featured answer: Orange Book listings govern patent exclusivity and generic entry eligibility, not brand supplier identity.

Why this matters for “suppliers”

• If a supplier is considering producing a generic or AB-rated product, the Orange Book determines whether an FDA approval pathway can proceed under:
  • Paragraph I, II, III, IV certifications
  • exclusivity blocks tied to application and listed patents

How does generic competition risk supplier contracts for Odomzo?

Featured answer: Generic competition risk primarily affects market share and may influence Novartis’s long-term supply planning, but it does not automatically change the brand’s upstream suppliers.

What does change when generics approach

• Novartis may shift manufacturing sites to maintain supply, reduce cost, or manage regulatory inspection focus
• CMOs may diversify for other oncology products, changing capacity allocations

What FDA pathways and regulatory obligations drive Odomzo manufacturing supply?

Featured answer: Odomzo is regulated under the NDA framework; batch release and CMC compliance govern manufacturing continuity.

Regulatory touchpoints relevant to suppliers

• NDA CMC controls for:
  • API specification
  • drug product dissolution and assay limits
  • stability program maintenance
• Change control procedures for site transfers, scale-ups, or process updates

What patent estate and exclusivity timelines affect supply and manufacturing transfers?

Featured answer: Patent and exclusivity status influences generic entry, not direct supplier identity, but it can drive whether Novartis invests in additional redundancy.

Supplier redundancy logic under exclusivity

• Under longer exclusivity periods, brands often keep:
  • a primary plant plus a validated secondary site
  • defined contingency supply plans to maintain continuity during inspections, deviations, or capacity reductions

Key Takeaways

• Novartis is the primary supplier for Odomzo in the US under the branded distribution model.
• Publicly indexed sources do not provide a complete, current, site-by-site list of sonidegib API suppliers and capsule manufacturing plants in a single extractable record.
• Supplier availability risk is driven by API and capsule batch release timing and capacity constraints, not by Orange Book status.
• Orange Book and exclusivity determine generic entry timing, which can indirectly affect long-run manufacturing strategy.

FAQs

1. Who sells Odomzo in the US, Novartis or third-party distributors?
   Odomzo is sold through US wholesaler channels; the commercial supplier for the brand product is Novartis.

2. Can a generic manufacture sonidegib capsules before Orange Book exclusivity expires?
   Generic manufacture and FDA approval depend on Orange Book patent certifications and exclusivity; manufacturing without FDA approval does not make a product AB-rated.

3. Does Odomzo require sterile manufacturing, and does that limit suppliers?
   No. Odomzo is an oral capsule; it does not carry sterile manufacturing constraints.

4. What supply chain choke points most affect sonidegib products?
   API intermediate availability, capsule manufacturing uptime, and analytic release testing timing.

5. Do supplier identities change over time for branded oncology capsules like Odomzo?
   Yes. CMO and site usage can change due to capacity, cost, and inspection-driven compliance planning, but brand-level supply typically remains controlled by the NDA system.

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References (APA)

1. 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/daf/
2. FDA. (n.d.). Drugs@FDA: Odomzo. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/