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Suppliers and packagers for generic pharmaceutical drug: AVATROMBOPAG MALEATE
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AVATROMBOPAG MALEATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Akarx Inc | DOPTELET SPRINKLE | avatrombopag maleate | GRANULE;ORAL | 219696 | NDA | AkaRx, Inc. | 71369-010-30 | 1 BOTTLE in 1 CARTON (71369-010-30) / 30 GRANULE in 1 BOTTLE | 2025-07-25 |
| Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238 | NDA | AkaRx, Inc. | 71369-020-10 | 1 BLISTER PACK in 1 CARTON (71369-020-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-11) | 2018-05-23 |
| Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238 | NDA | AkaRx, Inc. | 71369-020-15 | 1 BLISTER PACK in 1 CARTON (71369-020-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-16) | 2018-05-23 |
| Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238 | NDA | AkaRx, Inc. | 71369-020-30 | 2 BLISTER PACK in 1 CARTON (71369-020-30) / 15 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-16) | 2018-05-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: AVATROMBOPAG MALEATE
Introduction
Avatrombopag Maleate is a thrombopoietin receptor agonist primarily used to increase platelet counts in patients with chronic liver disease-associated thrombocytopenia and for those undergoing procedures requiring bleeding risk management. As a novel therapeutic agent, its supply chain comprises a network of manufacturers, authorized distributors, and regional sources. Ensuring a reliable, compliant, and cost-effective supply of Avatrombopag Maleate is critical for healthcare providers, pharmaceutical companies, and procurement organizations.
This article examines the key suppliers involved in the cultivation, synthesis, formulation, and distribution of Avatrombopag Maleate, providing insights into their roles, geographic presence, and regulatory status.
Manufacturers of Active Pharmaceutical Ingredient (API)
The core of the supply chain for Avatrombopag Maleate begins with the production of its API. Though the original innovator product is branded Doptelet®, developed by Daiichi Sankyo, a global pharmaceutical leader, several third-party suppliers and contract manufacturing organizations (CMOs) also produce Avatrombopag API under licensing agreements and sourcing arrangements.
Daiichi Sankyo’s Role and Authorized Suppliers
Daiichi Sankyo holds the patent rights, regulatory approvals, and manufacturing facilities for the original API. Their manufacturing units are located primarily in Japan and North America, adhering to rigorous Good Manufacturing Practices (GMP). The company's manufacturing facilities are approved by major health authorities such as the FDA, PMDA (Japan), and EMA.
Third-Party API Suppliers
Post-approval, Daiichi Sankyo may engage authorized CMOs in India, China, and Southeast Asia to supplement API production, especially for regional market demands. These CMOs often supply to generic manufacturers or authorized distributors under strict compliance with international GMP standards.
Emerging API Manufacturers
Although no publicly available data confirms the existence of multiple independent API manufacturers specifically for Avatrombopag Maleate, in the pharmaceutical industry, such APIs are typically produced by specialized CMO companies. Examples include:
- FAM (Factory of Active Pharmaceutical Ingredients) in India.
- Chinese pharmaceutical CMOs like Lianzhou Zhongxin and Wuxi AppTec are known to produce similar compounds and may have the capability under licensing agreements.
Market Access and Licensing
Supply agreements often require stringent licensing, quality assurance, and batch validation to meet regulatory standards. Therefore, the number of reliable, approved API suppliers remains limited and tightly controlled.
Finished Dosage Form Manufacturers and Distributors
Following API synthesis, pharmaceutical companies formulate Avatrombopag Maleate into tablets, adhering to strict quality control measures. The distribution network involves regional distributors, wholesale vendors, and healthcare providers.
Brand-Name and Generic Manufacturers
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Daiichi Sankyo: As the originator, they manufacture and distribute Doptelet® globally, with primary markets in the US, Europe, and Japan.
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Generics and Biosimilars: Several generic manufacturers leverage authorized APIs to produce equivalent formulations. These include companies based in India (e.g., Sun Pharma, Cipla) and China (Zhuhai Livzon Pharmaceutical), which may manufacture Avatrombopag formulations under licensing agreements or in parallel import channels.
Regional Distributors
Market-specific importers and wholesalers secure the drug's distribution, ensuring compliance with regional regulatory frameworks, such as the FDA in the US, EMA in Europe, and the CFDA/NMPA in China.
Supply Chain Challenges
The relatively recent approval of Avatrombopag has limited the number of licensed, high-volume manufacturers outside the original patent holder, impacting global supply availability. Counterfeit and gray-market sources proliferate in some regions, underscoring the importance of sourcing from reputable, approved suppliers.
Regulatory and Licensing Environment
Key to the supply chain sustainability is the regulatory landscape governing Avatrombopag Maleate:
- US Market: FDA approval granted in 2018 for thrombocytopenia in chronic liver disease and procedures.
- European Market: EMA approval secured, allowing authorized distribution.
- Other Regions: Licensing varies, with some countries allowing generics through partnerships with local manufacturers.
Daiichi Sankyo maintains strict licensing and quality standards, with authorized third-party manufacturing and distribution channels established to ensure product integrity and compliance.
Future Supply Trends and Opportunities
Emerging demand for thrombopoietic agents and the expansion of indications will likely stimulate increased API production capacity and new manufacturers entering the market. Strategic partnerships, licensing agreements, and technological advances in synthesis pathways may diversify the supplier base, improving supply resilience.
Regional manufacturing hubs, particularly in Asia, are poised to play a significant role in scaling up production and reducing costs, provided quality standards are maintained.
Key Considerations for Stakeholders
- Quality assurance remains paramount; verify suppliers hold current GMP certifications and regulatory approvals.
- Supply chain transparency aids procurement planning and risk mitigation.
- Regional sourcing should balance cost efficiency with compliance and regulatory acceptance.
- Patent and licensing status influences the availability of certain suppliers and formulations.
Conclusion
The supply chain for Avatrombopag Maleate hinges on a limited number of authorized API producers, predominantly controlled by Daiichi Sankyo, complemented by regional CMOs and generic manufacturers. Navigating this landscape requires diligence in supplier verification, regulatory compliance, and strategic sourcing to ensure uninterrupted access to this critical thrombopoietic agent.
Key Takeaways
- Daiichi Sankyo is the primary manufacturer of Avatrombopag API and the originator of branded formulations.
- The global supplier base beyond the patent holder remains limited, with authorized CMOs and licensed generic manufacturers forming the backbone of supply.
- Regional manufacturing and distribution are influenced heavily by licensing agreements and regulatory approvals, impacting availability.
- Ensuring GMP compliance, regulatory certification, and supply chain transparency is essential for procurement and distribution.
- Future market expansion and technological advances are expected to enhance supply chain robustness and regional accessibility.
FAQs
1. Who are the main manufacturers of Avatrombopag Maleate API?
Daiichi Sankyo is the primary manufacturer, with potential licensed third-party CMOs in Asia producing the API under strict regulatory compliance. No publicly available independent API producers are widely recognized for Avatrombopag.
2. Can I source Avatrombopag Maleate from generic manufacturers?
Yes, licensed generics are available typically through regional manufacturers partnering with Daiichi Sankyo or holding licensing rights. Ensure sourcing from authorized and GMP-certified suppliers to guarantee product quality.
3. How does licensing affect supply availability?
Licensing agreements restrict manufacturing and distribution to approved partners, directly impacting the number of suppliers and regional availability of Avatrombopag Maleate.
4. Are there regional differences in Avatrombopag suppliers?
Yes, regional regulatory approvals and licensing influence local manufacturer licensing. In some countries, local generics may be produced under authorized licensing agreements, whereas in others, imports are the primary source.
5. What should healthcare providers consider when procuring Avatrombopag Maleate?
Providers should verify the supplier's regulatory status, GMP compliance, and authenticity of the product, avoiding counterfeit sources, to ensure safety and efficacy.
References
- Daiichi Sankyo. (2018). Doptelet (Avatrombopag) prescribing information.
- European Medicines Agency. (2019). Summary of product characteristics for Doptelet.
- US Food and Drug Administration. (2018). FDA approval for Avatrombopag in thrombocytopenia.
- Oracle Healthcare Market Reports. (2022). Global API manufacturing landscape.
- Regulatory Affairs Professionals Society. (2023). Global licensing trends and supply chain impacts for novel agents.
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