Suppliers and packagers for generic pharmaceutical drug: nilotinib

nilotinib

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Flex Pharma	CAVHANZA	nilotinib	TABLET, ORALLY DISINTEGRATING;ORAL	217379	NDA	Cycle Pharmaceuticals Ltd	70709-191-12	112 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70709-191-12)	2026-06-30
Flex Pharma	CAVHANZA	nilotinib	TABLET, ORALLY DISINTEGRATING;ORAL	217379	NDA	Cycle Pharmaceuticals Ltd	70709-192-12	112 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70709-192-12)	2026-06-30

Suppliers and packagers for generic pharmaceutical drug: nilotinib

Last updated: July 27, 2026

Nilotinib Suppliers: Who Manufactures the Drug Substance and Finished Product for US and EU Markets?

Nilotinib’s supply chain is bifurcated between (1) active pharmaceutical ingredient (API) manufacturers that produce nilotinib (and, in many cases, key intermediates) and (2) finished-dose manufacturers that produce capsules/tablets for branded and generic markets. Nilotinib is sold globally under branded names including Tasigna (Novartis) and is also supplied as generic products in multiple strengths (commonly 150 mg and 200 mg capsules in the US market).

This brief maps the supplier universe at two levels: branded supply (proven finished-product manufacturer footprint) and generic supply (ANDA/facility-linked manufacturer footprint). It also flags the two supply constraints that most frequently shape nilotinib availability: (1) control of specialized synthesis routes and (2) regulatory filing linkage between ANDA sites and the commercial launch lots.

What companies supply nilotinib capsules (finished product) in the US market?

Short answer: Branded nilotinib capsules are supplied through Novartis’s global manufacturing network and contract manufacturing sites validated for FDA commercial distribution. Generic nilotinib capsules are supplied via multiple FDA-listed manufacturing facilities tied to individual ANDAs, label strengths, and packaging configurations.

US branded supply footprint (Tasigna)

• Brand: Tasigna (nilotinib)
• Label holder: Novartis
• Manufacturing: Tasigna is produced through Novartis manufacturing and/or qualified contract manufacturing sites listed on FDA labeling and corresponding inspection histories tied to the product (NDC-specific).

US generic supply footprint (ANDA manufacturers)

Generic nilotinib supply is split by:

• ANDA-specific manufacturing sites for drug product (capsule fill, capsule sealing, packaging)
• API manufacturing sites referenced in the Chemistry/CMC sections of each ANDA

The practical takeaway for procurement and risk planning is that supplier substitution across brands is typically constrained by:

• FDA facility linkage for each ANDA
• consistent dissolution and release specifications for immediate-release capsule presentation
• stability and cold-chain requirements are generally not dominant for nilotinib capsules, but packaging integrity and moisture control are.

What companies supply nilotinib API (drug substance)?

Short answer: Nilotinib API is manufactured by a limited set of qualified API producers with capability to produce advanced intermediates and the final API under GMP with site approvals supporting US/EU registrations.

In practice, nilotinib API supply is concentrated in:

• specialty small-molecule API firms with halogenated-heterocycle synthesis capability
• manufacturers that already have FDA-acceptable GMP histories for complex tyrosine kinase inhibitor (TKI) APIs

Typical API supplier qualification path

API suppliers generally enter nilotinib supply chains through:

• linkage to branded manufacturing supply contracts
• registration as drug substance manufacturer for ANDAs
• platform CMO/API consortia that deliver both API and intermediate steps

For nilotinib specifically, API qualification often depends on:

• control strategy for genotoxic impurities
• polymorph/crystal form consistency
• impurity profiling tied to the exact synthetic route used

Which suppliers are tied to approved ANDAs for generic nilotinib?

Short answer: Generic nilotinib suppliers are identifiable by ANDA drug product manufacturers (capsule manufacturing sites) and corresponding drug substance manufacturers cited in each ANDA.

Why ANDA linkage matters

Each ANDA ties:

• a specific drug product manufacturing site (and usually additional sites for secondary packaging)
• a specific drug substance manufacturing site
• validated analytical methods and release specs

Procurement actions that ignore ANDA-site linkage create substitution risk at:

• release testing failure rates
• dissolution profile variation
• stability lot-to-lot drift

What manufacturers supply nilotinib in Europe and UK markets?

Short answer: Europe and UK supply reflect:

• brand distribution via Novartis’s EU/UK manufacturing network
• generic distribution via EU GMP sites referenced in national marketing authorizations and mutual recognition/decentralized filings

European supply is typically managed through:

• local or regional wholesalers supported by tender procurement
• consistent labeling and EU batch release under EMA/National authority requirements

How do nilotinib supplier constraints affect availability and pricing?

Nilotinib supply constraints tend to cluster into three failure modes:

1. GMP site capacity shocks for capsule fill/packaging steps
2. API impurity control and genotoxic impurity specification tightening that can delay batch release
3. Regulatory update cadence (CMC supplements and site change notifications) that can slow continuity of supply

Procurement risk signals used in practice

• ANDA lot continuity for each NDC/strength
• recent GMP inspection outcomes for referenced facilities
• frequency of packaging component re-sourcing (bottles, closures, blister components if applicable)
• documented CMC supplement activity tied to dissolution/impurity profiles

Which nilotinib formulations drive supplier selection (capsule strengths and dosage forms)?

Short answer: Supplier selection is typically strength-specific for nilotinib capsules and is driven by capsule fill processes and validated dissolution methods.

Dosage form concentration

• Nilotinib is primarily commercialized as capsules in key markets.
• Supplier qualification often must match:
  • capsule size and fill blend composition
  • coating and moisture protection
  • stability data for the exact packaging configuration

What is the supplier landscape for Tasigna (Novartis) versus generic nilotinib?

Short answer: Tasigna is supplied through Novartis-controlled manufacturing and its validated CMO network. Generic nilotinib is supplied through ANDA-specific manufacturing networks that vary by strength and NDC.

Competitive supply pattern

• Branded supply shows more stable continuity historically because it runs through established global manufacturing planning.
• Generic supply shows more variability across:
  • launch-to-market ramp
  • packaging-line availability
  • CMC supplemental changes

Key Takeaways

• Nilotinib supply is controlled by FDA/EMA-linked manufacturing sites for both API and capsule drug product.
• Branded supply (Tasigna) runs through Novartis’s validated manufacturing and CMO network.
• Generic supply is determined by ANDA drug product and drug substance facilities tied to each strength and NDC.
• The highest operational risk is usually driven by GMP capacity, API impurity control, and CMC changes affecting batch release.

FAQs

1. What are the most common NDC strengths for nilotinib capsules in the US?
2. How can procurement teams verify nilotinib API and drug product manufacturing sites for a specific generic NDC?
3. What CMC factors most often delay nilotinib batch release for generic manufacturers?
4. Do nilotinib capsules require special storage conditions that constrain suppliers?
5. What drives differences in bioavailability or dissolution performance among nilotinib generics?

References

1. US FDA. Drug Labeling for Tasigna (nilotinib). (Accessed via FDA Drugs@FDA).
2. US FDA. Drugs@FDA database (nilotinib ANDAs and labeling information).
3. EMA. Product information and EPARs for Tasigna and generic nilotinib marketing authorizations.