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Suppliers and packagers for generic pharmaceutical drug: PONATINIB HYDROCHLORIDE
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PONATINIB HYDROCHLORIDE
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ponatinib Hydrochloride
Introduction
Ponatinib hydrochloride is an oral tyrosine kinase inhibitor primarily indicated for the treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Approved by the U.S. Food and Drug Administration (FDA) in 2012, ponatinib is sold under the brand name Iclusig. As an essential medication in targeted cancer therapies, its manufacturing, sourcing, and supply chain are highly scrutinized, especially amidst global supply-demand fluctuations and regulatory oversight.
This report provides an overview of the leading suppliers producing ponatinib hydrochloride, key manufacturing regions, regulatory statuses, and the competitive landscape. It aims to enable pharmaceutical professionals, investors, and healthcare policymakers to assess the current supply ecosystem effectively.
Manufacturers and Suppliers Overview
1. Original Equipment Manufacturers (OEMs)
The development and initial commercialization of ponatinib hydrochloride are primarily associated with Ariad Pharmaceuticals (now part of Takeda Pharmaceutical Company Limited), which first developed ponatinib. Following its approval, Takeda assumed exclusive manufacturing rights and became the dominant supplier globally. Takeda's manufacturing facilities are reportedly based in Japan and Europe, adhering to Good Manufacturing Practice (GMP) standards.
Takeda Pharmaceutical Company Limited is the primary supplier of commercial-scale ponatinib hydrochloride. They control the supply chain, ensuring consistent quality and regulatory compliance across markets. Takeda’s global logistics network facilitates distribution to North America, Europe, Asia, and other regions.
2. Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs)
Given the high complexity and strict regulatory standards, many pharmaceutical firms depend on outsourced manufacturing. Several CMOs and CDMOs, specializing in complex API (Active Pharmaceutical Ingredient) synthesis, have been engaged in producing ponatinib hydrochloride:
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Patheon (a part of Thermo Fisher Scientific) – Known for its API manufacturing expertise and GMP compliance, Patheon has been involved in producing customized APIs for various targeted therapies, including ponatinib, under licensing agreements.
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Biocon – An Indian biopharmaceutical firm with a rising API manufacturing portfolio, capable of producing complex small molecules under strict GMP standards. Biocon's facilities are approved by global regulators including the US FDA and EMA.
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Hisun Pharma – A Chinese pharmaceutical company with API manufacturing capabilities expanding their portfolio to include oncology drugs like ponatinib. Hisun's API facilities are certified by local and international agencies, positioning it as a potential supplier for regional markets.
3. Regional Suppliers and Generics Manufacturers
While the original formulation and supply are controlled by Takeda, regional and generic manufacturers in emerging markets are increasingly seeking licensure or API sourcing opportunities:
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Sino Biopharmaceutical Limited (Hong Kong) – Has been exploring partnerships for biosimilar development and API manufacturing of tyrosine kinase inhibitors, including ponatinib.
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Hunan Er-Kang Pharmaceutical Co., Ltd. – An established Chinese manufacturer, actively seeking to develop or produce generic versions of oncology APIs, potentially including ponatinib hydrochloride pending regulatory approval.
Regulatory and Quality Considerations
Suppliers of ponatinib hydrochloride must meet stringent regulatory standards, including those set by the FDA, EMA, and other national agencies. Takeda, as the original developer, maintains BLA (Biologics License Application) and ANDA (Abbreviated New Drug Application) filings, ensuring quality compliance and traceability.
Regional suppliers, especially in China and India, have ramped up GMP standards, often seeking approval from their national regulators. However, variability in quality standards across regions necessitates due diligence for healthcare providers and distributors when sourcing from various suppliers.
Supply Chain Dynamics and Challenges
The supply of ponatinib hydrochloride has faced challenges including manufacturing complexity, regulatory delays, and supply-demand imbalances. Factors influencing its supply include:
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Manufacturing Complexity: The synthesis of ponatinib involves complex chemical processes demanding high purity and strict control, limiting the number of viable manufacturing partners.
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Regulatory Approvals: Regulatory hurdles can delay the entry of new suppliers, constraining supply flexibility.
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Global Demand: As a critical therapy for resistant or intolerant cases of CML, global demand spikes have strained existing suppliers, prompting manufacturing scale-up initiatives.
Recently, Takeda has emphasized maintaining robust supply chains, alongside expanding partnerships with CMOs in emerging markets to meet regional demand and prevent shortages.
Market and Competitive Landscape
While Takeda remains the predominant global supplier, the increasing interest in biosimilars and generics in oncology may lead to new entrants. Strategies include licensing agreements with regional manufacturers and technology transfer arrangements to produce high-quality APIs locally.
Emerging suppliers in Asia and collaborations with contract manufacturers are expected to influence supply dynamics over the next five years. However, the high barriers to entry—due to complex synthesis, regulatory approval processes, and quality assurance—favor established players like Takeda.
Conclusion
The supply of ponatinib hydrochloride is largely centered around Takeda Pharmaceutical, supported by specialized CMOs and regional manufacturers in Asia. The landscape is characterized by limited, highly regulated suppliers capable of meeting global demand, with ongoing efforts to diversify manufacturing sources through partnerships and licensing. Ensuring supply continuity remains a strategic priority for stakeholders involved in cancer treatment.
Key Takeaways
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Takeda Pharmaceutical is the primary and most reliable supplier of ponatinib hydrochloride globally, controlling manufacturing and distribution.
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Contract manufacturing organizations like Patheon, Biocon, and Hisun play vital roles in supplementing supply, especially in regional markets.
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Approximately, the manufacturing of ponatinib involves complex chemical processes, limiting the number of qualified suppliers.
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Regional suppliers are increasingly seeking regulatory approvals and partnerships to penetrate markets with generic or biosimilar versions.
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Ensuring regulatory compliance and manufacturing quality is critical for maintaining a stable supply chain.
FAQs
1. Who are the leading global suppliers of ponatinib hydrochloride?
Takeda Pharmaceutical is the principal global supplier, with additional capacity supplied by CMOs such as Patheon, Biocon, and Hisun Pharma in Asia.
2. Can regional manufacturers produce ponatinib hydrochloride?
Yes. Some regional manufacturers in China and India have the technical capacity and GMP certification to produce ponatinib API, although regulatory approval is necessary for commercialization.
3. What challenges affect the supply of ponatinib hydrochloride?
Complex synthesis processes, regulatory approval delays, and increasing demand can impact supply stability. Manufacturing capacity is also limited due to the chemical complexity involved.
4. Are there generic or biosimilar versions of ponatinib available?
Current supplies are mainly from original developers like Takeda. However, regional companies are exploring generics and biosimilars, contingent on regulatory approvals.
5. How does regulatory compliance influence suppliers’ ability to distribute ponatinib?
Regulatory approval ensures that manufacturers meet quality standards; non-compliance can lead to delays or bans, restricting supply and affecting drug availability.
Sources
[1] U.S. FDA. “Iclusig (Ponatinib) Prescribing Information.” 2012.
[2] Takeda Pharmaceutical. “Product Portfolio and Manufacturing Capabilities.”
[3] GlobalData. “Pharmaceutical API Manufacturing Market Analysis.” 2022.
[4] Indian Pharma News. “Emerging Market APIs for Oncology Drugs.” 2021.
[5] World Health Organization. “GMP Certification Guidelines for API Manufacturing.”
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