Suppliers and packagers for iclusig

iclusig

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469	NDA	Takeda Pharmaceuticals America, Inc.	63020-533-30	30 TABLET, FILM COATED in 1 BOTTLE (63020-533-30)	2015-04-22
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469	NDA	Takeda Pharmaceuticals America, Inc.	63020-534-30	30 TABLET, FILM COATED in 1 BOTTLE (63020-534-30)	2012-12-14
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469	NDA	Takeda Pharmaceuticals America, Inc.	63020-535-30	30 TABLET, FILM COATED in 1 BOTTLE (63020-535-30)	2012-12-14
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469	NDA	Takeda Pharmaceuticals America, Inc.	63020-535-60	60 TABLET, FILM COATED in 1 BOTTLE (63020-535-60)	2012-12-14
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469	NDA	Takeda Pharmaceuticals America, Inc.	63020-536-30	30 TABLET, FILM COATED in 1 BOTTLE (63020-536-30)	2021-01-11

ICLUSIG: Key Suppliers and Manufacturing Landscape

Last updated: February 19, 2026

This report identifies key suppliers involved in the manufacturing and supply chain of ICLUSIG (ponatinib hydrochloride), a tyrosine kinase inhibitor. The analysis focuses on active pharmaceutical ingredient (API) production, formulation, and key excipient providers. Understanding this ecosystem is critical for supply chain risk assessment and strategic sourcing within the oncology drug market.

What is ICLUSIG and Who Manufactures It?

ICLUSIG is a small molecule drug approved for specific indications of chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that are resistant to other tyrosine kinase inhibitors. The active pharmaceutical ingredient is ponatinib hydrochloride.

The drug is developed and marketed by Takeda Pharmaceutical Company Limited. Takeda is responsible for the global supply and commercialization of ICLUSIG.

Who Supplies the Active Pharmaceutical Ingredient (API)?

The synthesis of ponatinib hydrochloride, the API for ICLUSIG, involves complex multi-step chemical processes. While specific contract manufacturing organizations (CMOs) are often not publicly disclosed by pharmaceutical companies for proprietary reasons, general industry practices and available information suggest a reliance on specialized chemical manufacturers.

Companies with expertise in complex organic synthesis, particularly for oncology APIs, are typically involved. These manufacturers operate under strict Good Manufacturing Practices (GMP) and are subject to rigorous regulatory oversight by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Potential API Manufacturing Landscape:

• Global Chemical Synthesis Companies: Large multinational chemical and pharmaceutical ingredient manufacturers with significant R&D capabilities and dedicated GMP manufacturing facilities are likely candidates. These companies often possess the technical expertise and regulatory compliance to produce complex small molecules.
• Specialized CMOs: Contract Manufacturing Organizations that focus on the production of high-potency APIs (HPAPIs) are essential. HPAPIs require specialized containment and handling procedures due to their biological activity.
• Geographic Concentration: API manufacturing for such specialized drugs can be concentrated in regions with established pharmaceutical manufacturing infrastructure and skilled labor, including North America, Europe, and parts of Asia (e.g., India and China), though high-potency API production may be more geographically constrained.

Direct information on the specific CMOs manufacturing ponatinib hydrochloride for ICLUSIG is not publicly disclosed by Takeda. This information is typically considered proprietary competitive intelligence.

What Excipients are Used in ICLUSIG Formulations?

ICLUSIG is formulated as film-coated tablets. The specific inactive ingredients (excipients) used are critical for drug stability, bioavailability, and patient administration. These excipients are sourced from a range of specialized chemical suppliers.

The quantitative composition of excipients is detailed in the drug's regulatory filings and package inserts. Common excipients in film-coated tablets include:

• Fillers/Diluents: These provide bulk to the tablet.
  • Microcrystalline Cellulose: Commonly used for its compressibility and binding properties. Suppliers like FMC Corporation and JRS Pharma are major global providers.
  • Lactose Monohydrate: Another common filler, though less likely in certain formulations due to patient intolerances. Major suppliers include DMV-Fonterra Excipients.
• Binders: These help the powder particles adhere to each other during granulation.
  • Povidone (Polyvinylpyrrolidone): Widely used for its binding efficacy. Manufacturers like BASF SE and Ashland Global Holdings Inc. are key suppliers.
  • Hydroxypropyl Cellulose: Another effective binder.
• Disintegrants: These help the tablet break apart in the gastrointestinal tract to release the API.
  • Croscarmellose Sodium: A highly effective superdisintegrant. Suppliers include Dow Inc. and JRS Pharma.
  • Sodium Starch Glycolate: Also widely used.
• Lubricants: These prevent sticking to tablet press machinery.
  • Magnesium Stearate: The most common lubricant. Suppliers are numerous, including companies like Mallinckrodt Pharmaceuticals and Avantor, Inc.
  • Stearic Acid: Can also be used.
• Glidants: These improve powder flow.
  • Colloidal Silicon Dioxide: Enhances powder flowability. Cabot Corporation and Evonik Industries AG are significant manufacturers.
• Film-Coating Agents: These form the outer layer of the tablet.
  • Hypromellose (Hydroxypropyl Methylcellulose - HPMC): A very common film-former. The Dow Chemical Company (through its DOW website and brand names like Colorcon) and Ashland Global Holdings Inc. are major providers.
  • Polyethylene Glycol (PEG): Used as a plasticizer in the coating.
  • Titanium Dioxide: Used as an opacifier and white pigment. Venator Materials PLC and Kronos Worldwide, Inc. are major producers.
  • Iron Oxides (Red, Yellow): Used for tablet color.
  • Talc: Can be used as an anti-adherent in coatings.

Table 1: Common Excipients and Potential Suppliers in ICLUSIG Tablet Formulation

Excipient Category	Example Excipient	Potential Global Suppliers
Fillers/Diluents	Microcrystalline Cellulose	FMC Corporation, JRS Pharma
Binders	Povidone (PVP)	BASF SE, Ashland Global Holdings Inc.
Disintegrants	Croscarmellose Sodium	Dow Inc., JRS Pharma
Lubricants	Magnesium Stearate	Mallinckrodt Pharmaceuticals, Avantor, Inc.
Glidants	Colloidal Silicon Dioxide	Cabot Corporation, Evonik Industries AG
Film-Coating Agents	Hypromellose (HPMC)	The Dow Chemical Company (Colorcon), Ashland Global Holdings Inc.
Film-Coating Agents	Titanium Dioxide	Venator Materials PLC, Kronos Worldwide, Inc.

Note: Specific excipients and their exact suppliers for ICLUSIG are proprietary and subject to change. This table reflects common industry practices.

What is the Regulatory Framework for ICLUSIG Manufacturing?

The manufacturing of ICLUSIG, including both the API and finished drug product, is governed by stringent regulatory requirements in all major markets.

• Good Manufacturing Practices (GMP): Pharmaceutical manufacturers must adhere to GMP guidelines, which cover all aspects of production, from raw material sourcing and facility design to quality control and product distribution. In the US, these are enforced by the FDA under 21 CFR Parts 210 and 211. In Europe, they are overseen by the EMA and national competent authorities.
• API Master Files (APIMFs) / Drug Master Files (DMFs): API manufacturers typically submit detailed information about their manufacturing process, facilities, and quality control to regulatory agencies through DMFs (in the US) or similar filings in other regions. The drug product applicant (Takeda) references these filings in their own marketing applications.
• Supply Chain Security: Regulations increasingly focus on supply chain integrity and traceability to prevent counterfeiting and ensure product quality. This includes secure transportation and storage of materials and finished products.
• Post-Approval Changes: Any changes to the manufacturing process, suppliers, or specifications of either the API or excipients require regulatory approval from health authorities before implementation. This ensures that quality and safety are not compromised.
• Inspections: Regulatory agencies conduct regular inspections of manufacturing facilities to ensure ongoing compliance with GMP and marketing authorization conditions.

Who are the Key Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs)?

Takeda, as the marketing authorization holder for ICLUSIG, may utilize various CMOs and CDMOs for different stages of the drug's lifecycle. While Takeda likely has internal manufacturing capabilities, outsourcing is common for capacity, specialized expertise, or cost efficiency.

• API Synthesis: As noted, specialized CMOs with expertise in complex organic synthesis and HPAPI handling are crucial. Examples of global CDMOs with such capabilities include Lonza Group AG, Catalent, Inc., Thermo Fisher Scientific (through its Patheon brand), and WuXi AppTec.
• Drug Product Manufacturing (Formulation and Packaging): The formulation of ponatinib hydrochloride into tablets and subsequent packaging may be performed by a separate set of CMOs. These facilities would need capabilities for solid oral dosage form manufacturing, granulation, compression, coating, and blistering or bottling.

Table 2: Leading Global CDMOs with Relevant Capabilities

CDMO Name	Key Capabilities
Lonza Group AG	Small molecule API synthesis, HPAPI manufacturing, drug product development and manufacturing.
Catalent, Inc.	Drug substance and drug product manufacturing, advanced drug delivery technologies.
Thermo Fisher Scientific (Patheon)	End-to-end CDMO services, including API synthesis, sterile and non-sterile drug product.
WuXi AppTec	Small molecule R&D and manufacturing, cell and gene therapy services, analytical services.
Siegfried AG	API and drug product manufacturing, high-potency compounds.

Note: Inclusion on this list does not confirm a contractual relationship with Takeda for ICLUSIG. It represents companies with the technical and regulatory capacity.

What is the Supply Chain Risk Profile for ICLUSIG?

The supply chain for ICLUSIG, like many complex oncology drugs, carries several inherent risks:

• API Complexity and Single Sourcing: The multi-step synthesis of ponatinib hydrochloride may limit the number of qualified manufacturers. If Takeda relies on a single API supplier, any disruption at that facility (e.g., due to quality issues, regulatory action, geopolitical events, or natural disasters) can significantly impact drug availability.
• Excipient Dependency: Reliance on specialized excipients, particularly those with limited suppliers, presents a vulnerability. Disruptions at a key excipient manufacturer can halt drug product manufacturing.
• Geopolitical Stability: Manufacturing sites for APIs and excipients can be located in regions subject to geopolitical instability, trade disputes, or stringent environmental regulations that could impact production.
• Regulatory Hurdles: Maintaining compliance with evolving GMP standards and obtaining timely approval for any manufacturing process changes is critical. Delays in regulatory approvals can impact supply continuity.
• Intellectual Property (IP) and Generics: While ICLUSIG is a branded product, understanding the patent landscape for both the API and its manufacturing processes is crucial for long-term supply strategy. Expired patents can open the door for generic competition, which may introduce new supply chain dynamics and pricing pressures.
• Quality Control Failures: Any lapse in quality control at any point in the supply chain, from raw materials to finished product, can lead to recalls, regulatory action, and significant supply disruptions.

What are the Key Takeaways?

• ICLUSIG (ponatinib hydrochloride) is manufactured and marketed by Takeda Pharmaceutical Company Limited.
• The active pharmaceutical ingredient (API) production likely involves specialized CMOs with expertise in complex organic synthesis and high-potency active pharmaceutical ingredients (HPAPIs).
• The formulation of ICLUSIG tablets utilizes a range of standard pharmaceutical excipients, sourced from global chemical suppliers such as FMC Corporation, BASF SE, Ashland Global Holdings Inc., Dow Inc., and The Dow Chemical Company.
• Manufacturing is strictly regulated under GMP by global health authorities (e.g., FDA, EMA), requiring rigorous quality control and regulatory compliance.
• Key risks in the ICLUSIG supply chain include potential single sourcing of the API, reliance on specialized excipients, geopolitical factors affecting manufacturing locations, and stringent regulatory oversight.
• Leading CDMOs like Lonza Group AG, Catalent, Inc., and Thermo Fisher Scientific (Patheon) possess the capabilities for API and drug product manufacturing relevant to complex oncology drugs like ICLUSIG.

Frequently Asked Questions

1. Where is the ICLUSIG API manufactured? Takeda Pharmaceutical Company Limited does not publicly disclose the specific contract manufacturing organizations (CMOs) or locations responsible for manufacturing the ponatinib hydrochloride API.

2. Who supplies the raw materials for ICLUSIG? The raw materials for ICLUSIG include chemical intermediates for API synthesis and various excipients for the tablet formulation. Specific suppliers for API intermediates are proprietary. For excipients, major global suppliers of microcrystalline cellulose, povidone, croscarmellose sodium, magnesium stearate, and film-coating agents are likely involved.

3. What are the primary excipients in an ICLUSIG tablet? Common excipients in ICLUSIG tablets, based on typical film-coated tablet formulations, include fillers like microcrystalline cellulose, binders such as povidone, disintegrants like croscarmellose sodium, lubricants like magnesium stearate, and film-coating agents including hypromellose and titanium dioxide.

4. Are there any known supply chain disruptions for ICLUSIG? Publicly available information does not detail specific, ongoing supply chain disruptions for ICLUSIG. Pharmaceutical companies closely manage their supply chains to mitigate such events.

5. What regulatory requirements must ICLUSIG manufacturers meet? Manufacturers must adhere to Good Manufacturing Practices (GMP), which are enforced by regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This includes stringent quality control, process validation, and facility compliance.

Cited Sources

[1] U.S. Food and Drug Administration. (n.d.). 21 CFR Part 210: Current Good Manufacturing Practice In Manufacturing, Processing, Packing, or Holding of Drugs; General. U.S. Government Publishing Office. [2] U.S. Food and Drug Administration. (n.d.). 21 CFR Part 211: Current Good Manufacturing Practice For Finished Pharmaceuticals. U.S. Government Publishing Office. [3] Takeda Pharmaceutical Company Limited. (n.d.). ICLUSIG® (ponatinib hydrochloride) Prescribing Information. (Specific version and date would be cited if a particular market’s PI were referenced, e.g., USPI, EMA SmPC). [4] European Medicines Agency. (n.d.). Good manufacturing practice (GMP). European Medicines Agency.