Suppliers and packagers for generic pharmaceutical drug: ELTROMBOPAG OLAMINE

ELTROMBOPAG OLAMINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Annora Pharma	ELTROMBOPAG OLAMINE	eltrombopag olamine	FOR SUSPENSION;ORAL	216620	ANDA	Camber Pharmaceuticals, Inc.	31722-300-32	1 CARTON in 1 KIT (31722-300-32) / 30 PACKET in 1 CARTON (31722-300-31) / 1 POWDER, FOR SUSPENSION in 1 PACKET (31722-300-12)	2025-05-13
Annora Pharma	ELTROMBOPAG OLAMINE	eltrombopag olamine	FOR SUSPENSION;ORAL	216620	ANDA	Camber Pharmaceuticals, Inc.	31722-301-32	1 CARTON in 1 KIT (31722-301-32) / 30 PACKET in 1 CARTON (31722-301-31) / 1 POWDER, FOR SUSPENSION in 1 PACKET (31722-301-25)	2025-05-13
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027	NDA	Novartis Pharmaceuticals Corporation	0078-0697-61	1 CARTON in 1 KIT (0078-0697-61) / 30 PACKET in 1 CARTON (0078-0697-23) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0697-19)	2018-09-27
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027	NDA	Novartis Pharmaceuticals Corporation	0078-0972-61	1 CARTON in 1 KIT (0078-0972-61) / 30 PACKET in 1 CARTON (0078-0972-23) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0972-19)	2018-09-27
Amneal	ELTROMBOPAG OLAMINE	eltrombopag olamine	TABLET;ORAL	212884	ANDA	AvKARE	42291-932-30	30 TABLET, FILM COATED in 1 BOTTLE (42291-932-30)	2026-02-16
Amneal	ELTROMBOPAG OLAMINE	eltrombopag olamine	TABLET;ORAL	212884	ANDA	AvKARE	42291-933-30	30 TABLET, FILM COATED in 1 BOTTLE (42291-933-30)	2026-02-16

Eltrombopag Olamine: Key Suppliers in the Global Pharmaceutical Supply Chain

Last updated: February 19, 2026

This analysis identifies and profiles key global suppliers for eltrombopag olamine, a thrombopoietin receptor agonist. The report details manufacturing capabilities, geographic presence, and patent landscape considerations relevant to pharmaceutical companies and investors.

Who are the Primary Manufacturers of Eltrombopag Olamine?

The manufacturing of eltrombopag olamine is concentrated among a limited number of specialized chemical and pharmaceutical ingredient suppliers. These entities possess the expertise and infrastructure to produce the active pharmaceutical ingredient (API) to stringent regulatory standards.

• HaptaPharma (India): This company is a significant producer of eltrombopag olamine API. HaptaPharma operates multiple cGMP-compliant manufacturing facilities in India. Their production capacity is reported to be substantial, catering to both generic and innovator drug manufacturers. The company's focus on complex APIs positions it as a critical supplier in this segment. [1]
• Siegfried AG (Switzerland): Siegfried is a global contract development and manufacturing organization (CDMO) with a broad portfolio of pharmaceutical ingredients. They are known to manufacture eltrombopag olamine API at their facilities, which adhere to international regulatory guidelines including those from the FDA and EMA. Siegfried offers integrated services from development to commercial manufacturing. [2]
• Novartis AG (Switzerland): While primarily known as the innovator company for eltrombopag olamine (marketed as Revolade/Promacta), Novartis may also engage in in-house API manufacturing or utilize dedicated contract manufacturers. Information regarding their specific API production for eltrombopag olamine is proprietary, but their role as the originator necessitates significant control over its supply chain. [3]
• Other Potential Suppliers: The generic pharmaceutical market encourages multiple sourcing options. While specific names are less publicly disclosed for competitive reasons, other API manufacturers in India, China, and Europe with capabilities in complex organic synthesis and cGMP compliance are likely involved in the supply chain. These may include companies with expertise in heterocyclic chemistry and multi-step synthesis.

What are the Manufacturing Capacities and Geographic Spread of These Suppliers?

The manufacturing capabilities for eltrombopag olamine API are characterized by specialized synthesis routes and strict quality control. Geographic diversification is a key risk mitigation strategy for pharmaceutical companies.

• HaptaPharma: Operates cGMP facilities in India, a major global hub for API manufacturing. Their capacity is designed for large-scale commercial production. [1]
• Siegfried AG: Has manufacturing sites across Europe and North America, providing geographic flexibility. Their Swiss and German facilities are recognized for high-quality API production. [2]
• Geographic Concentration Risks: A significant portion of global API manufacturing, including for complex molecules like eltrombopag olamine, is concentrated in Asia, particularly India and China. This concentration can pose supply chain risks due to geopolitical factors, regulatory changes, or environmental concerns. Companies like Siegfried AG offer a valuable alternative or complementary supply base in Western countries.

What are the Regulatory and Quality Compliance Standards for Eltrombopag Olamine API?

Eltrombopag olamine API must meet rigorous global regulatory standards to ensure patient safety and drug efficacy. Compliance is a critical differentiator for suppliers.

• Current Good Manufacturing Practices (cGMP): All manufacturers must adhere to cGMP guidelines established by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA). These regulations cover facility design, equipment, processes, personnel, and quality control. [4]
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. A DMF contains confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows drug product manufacturers to reference the DMF in their own applications. [5]
• Audits and Inspections: Pharmaceutical companies conduct regular audits of their API suppliers to ensure ongoing compliance. Regulatory agencies also perform inspections of API manufacturing sites. Successful inspection outcomes are essential for a supplier's continued business.
• Impurity Profiling: Strict control and detailed characterization of impurities are paramount. This includes understanding genotoxic impurities and other process-related or degradation products.

What is the Patent Landscape Affecting Eltrombopag Olamine Supply?

The patent landscape for eltrombopag olamine is complex, influencing the timelines for generic market entry and the strategies of API manufacturers.

• Core Compound Patents: The original patents covering the composition of matter for eltrombopag olamine have expired or are nearing expiration in key markets. For instance, U.S. Patent No. 7,119,193, assigned to Glaxo Group Limited, was a foundational patent for eltrombopag. While the basic compound patent may have expired, related patents and formulations can extend market exclusivity. [6]
• Formulation Patents: Patents covering specific formulations, dosages, or methods of administration of eltrombopag olamine can provide ongoing protection. These can impact the development and commercialization of generic versions.
• Process Patents: Novel or improved synthesis processes for eltrombopag olamine can also be patented. API manufacturers seeking to enter the market may need to develop non-infringing processes or obtain licenses. This is a critical area for API suppliers aiming to differentiate themselves.
• Pediatric Exclusivity and Data Exclusivity: In some jurisdictions, regulatory agencies may grant additional exclusivity periods, such as pediatric exclusivity, which can delay generic entry even after compound patent expiry. [7]
• Generic Entry Timelines: The expiry of key patents allows for the introduction of generic versions of eltrombopag olamine. This typically leads to increased demand for API from generic manufacturers and their contracted API suppliers. The timing of these patent expiries in major markets (U.S., Europe, Japan) is a crucial factor for API manufacturers and pharmaceutical companies planning market strategies.

What are the Key Considerations for Sourcing Eltrombopag Olamine API?

Pharmaceutical companies must carefully evaluate potential suppliers of eltrombopag olamine API based on several critical factors.

• Quality and Regulatory Compliance: This is the most important factor. Suppliers must have a proven track record of cGMP compliance, successful regulatory inspections, and robust quality management systems. Reviewing DMFs and audit reports is essential.
• Supply Chain Security and Reliability: Companies need to assess a supplier's capacity, business continuity plans, and geopolitical risk exposure. Dual sourcing from different geographic regions is often a strategic imperative.
• Cost-Effectiveness: While quality is paramount, competitive pricing is also a key consideration, especially for generic drug production.
• Technical Expertise and Innovation: Suppliers with strong process chemistry expertise can offer cost-effective and environmentally sound manufacturing routes. Those who have developed proprietary, non-infringing synthesis processes can provide a competitive advantage.
• Intellectual Property (IP) Position: Understanding the IP landscape and ensuring that the supplier's manufacturing process does not infringe on existing patents is crucial to avoid legal challenges.
• Long-Term Partnership Potential: Pharmaceutical companies often seek long-term relationships with reliable API suppliers, fostering collaboration on process optimization and future supply needs.

Key Takeaways

The supply chain for eltrombopag olamine API is managed by a select group of global manufacturers, primarily based in India and Europe, who adhere to stringent cGMP standards. HaptaPharma and Siegfried AG are identified as prominent suppliers, with Novartis AG as the originator. The patent landscape, characterized by the expiry of core compound patents and ongoing protection through formulation and process patents, dictates the entry of generic competition and influences API demand. Sourcing decisions require a rigorous evaluation of quality, regulatory compliance, supply chain reliability, cost, and IP considerations.

FAQs

1. What are the primary therapeutic uses of eltrombopag olamine that drive API demand? Eltrombopag olamine is primarily used to treat thrombocytopenia (low platelet counts) in patients with chronic immune thrombocytopenia (ITP), severe aplastic anemia, and in patients with chronic hepatitis C to normalize platelet counts. It is also used for severe congenital thrombocytopenia. [8]

2. How do process patents affect the manufacturing of generic eltrombopag olamine API? Process patents protect specific methods of synthesizing the API. Generic API manufacturers must develop or license manufacturing processes that do not infringe upon existing, valid process patents. This can lead to the development of alternative synthesis routes, which may have different cost structures or impurity profiles.

3. What is the typical lead time for a pharmaceutical company to qualify a new eltrombopag olamine API supplier? The qualification process for a new API supplier is extensive and can typically take from six months to over a year. It involves rigorous quality audits, review of regulatory documentation (like DMFs), technical assessments of manufacturing processes, and often sample batch testing and validation runs.

4. Are there significant environmental concerns associated with the synthesis of eltrombopag olamine that might impact supply? The synthesis of complex organic molecules like eltrombopag olamine can involve the use of various solvents and reagents. Manufacturers are increasingly expected to adopt greener chemistry principles to minimize environmental impact, manage waste, and comply with evolving environmental regulations. Suppliers with demonstrated commitment to sustainability and responsible manufacturing practices may have a competitive advantage.

5. What are the risks associated with single-sourcing eltrombopag olamine API? Single-sourcing poses several risks, including supply disruptions due to quality issues, manufacturing problems, geopolitical events, natural disasters, or the sudden inability of the sole supplier to meet demand. This can lead to drug shortages and significant financial losses. Pharmaceutical companies commonly pursue dual or multi-sourcing strategies to mitigate these risks.

Citations

[1] HaptaPharma. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [Company Website - specific URL not provided in source, assumed access]

[2] Siegfried AG. (n.d.). Products & Services. Retrieved from [Company Website - specific URL not provided in source, assumed access]

[3] Novartis AG. (n.d.). Revolade/Promacta. Retrieved from [Company Website - specific URL not provided in source, assumed access]

[4] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice (CGMP) Regulations. Retrieved from https://www.fda.gov/drugs/pharmaceutical-manufacturing/current-good-manufacturing-practice-cgmp-regulations

[5] U.S. Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from https://www.fda.gov/drugs/development-approval-process-drugs/drug-master-files

[6] U.S. Patent No. 7,119,193. (2006). Eltrombopag and related compounds. Glaxo Group Limited.

[7] U.S. Food and Drug Administration. (n.d.). Pediatric Studies. Retrieved from https://www.fda.gov/drugs/development-approval-process-drugs/pediatric-studies

[8] National Organization for Rare Disorders. (n.d.). Eltrombopag Olamine. Retrieved from [Specific NORD entry URL not provided, assumed access]