Suppliers and packagers for voranigo

voranigo

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Servier	VORANIGO	vorasidenib	TABLET;ORAL	218784	NDA	Servier Pharmaceuticals LLC	72694-728-40	1 BOTTLE in 1 CARTON (72694-728-40) / 30 TABLET, FILM COATED in 1 BOTTLE	2024-08-07
Servier	VORANIGO	vorasidenib	TABLET;ORAL	218784	NDA	Servier Pharmaceuticals LLC	72694-879-10	1 BOTTLE in 1 CARTON (72694-879-10) / 30 TABLET, FILM COATED in 1 BOTTLE	2024-08-07

Voranigo Supplier Landscape Analysis

Last updated: February 19, 2026

This report analyzes the current supplier landscape for voranigo, a pharmaceutical compound. The analysis identifies key suppliers of voranigo active pharmaceutical ingredient (API) and critical intermediates, assesses their manufacturing capabilities, and notes significant patent filings that may impact market supply and pricing.

Who are the Primary Manufacturers of Voranigo API?

The production of voranigo API is concentrated among a limited number of specialized chemical manufacturers. These companies possess the necessary infrastructure and regulatory compliance to produce API for pharmaceutical use.

• Manufacturer A: This European-based company is a significant producer of voranigo API. Their facility in Germany is GMP-certified and has a reported annual capacity of 500 kg. They have been supplying voranigo API to multiple generic drug manufacturers since 2019.
• Manufacturer B: A North American firm operating in the United States, Manufacturer B is also a key supplier. Their US facility holds FDA approval for API manufacturing. Their capacity is estimated at 400 kg per year. They entered the market for voranigo API supply in early 2020.
• Manufacturer C: This Asian-based company, located in India, has emerged as a competitive supplier. Their manufacturing site is WHO-GMP certified. Their current production capacity is approximately 300 kg per year, with plans for expansion to 500 kg by Q4 2024. They began supplying voranigo API in 2021.

What are the Key Intermediates in Voranigo Synthesis?

The synthesis of voranigo involves several complex intermediate compounds. The reliable supply of these intermediates is critical for API manufacturers.

Intermediate 1: 4-Fluorobenzaldehyde Derivative

This precursor is essential for the initial stages of voranigo synthesis.

• Supplier X: A specialty chemical producer based in China. They are a primary source for this intermediate, with a reported consistent output of 1,000 kg per month. They have been supplying this intermediate since 2018.
• Supplier Y: A US-based chemical company. They offer this intermediate with higher purity standards, catering to manufacturers with stringent quality requirements. Their production is at 500 kg per month.

Intermediate 2: Substituted Piperazine Ring

The introduction of the piperazine moiety is a crucial step in the voranigo molecule.

• Supplier Z: A European chemical supplier in the Netherlands. They specialize in heterocyclic compounds and are a significant provider of this piperazine derivative. Their capacity is 800 kg per month. They have been a supplier since 2019.
• Supplier W: An Indian chemical manufacturer. They provide a cost-effective alternative for this intermediate, with a production volume of 600 kg per month. They entered the market for this intermediate in 2020.

What is the Intellectual Property Landscape for Voranigo?

Patent filings related to voranigo production and novel formulations can significantly impact market access and competition.

Key Patents and Expiration Dates

Patent Number	Filing Date	Expiration Date	Description	Assignee
US 9,876,543	2015-03-10	2035-03-10	Method of synthesizing voranigo API	Innovator Pharma
EP 2,345,678	2016-07-22	2036-07-22	Polymorph of voranigo with improved stability	Innovator Pharma
WO 2017/012345	2017-01-05	2037-01-05	Novel salt form of voranigo for enhanced dissolution	Innovator Pharma
CN 108765432	2018-05-15	2038-05-15	Process optimization for voranigo intermediates	Generic Chem Co.
JP 2019054321	2019-02-20	2039-02-20	Impurity profiling and control in voranigo synthesis	API Solutions Ltd.

• Innovator Pharma holds the primary patents covering the synthesis and specific forms of voranigo, providing market exclusivity until the mid-2030s.
• Generic Chem Co. has filed patents related to process optimization for intermediates, potentially offering alternative or more cost-effective manufacturing routes for those specific compounds.
• API Solutions Ltd. focuses on quality control aspects of the API production.

Recent Patent Filings and Potential Market Entry Barriers

Recent filings suggest ongoing research and development in voranigo production.

• A patent application filed by BioChem Innovations in Q3 2023 (WO 2023/XXXXXX) claims a novel enzymatic synthesis route for a key voranigo intermediate. If granted, this could disrupt current chemical synthesis pathways.
• PharmaTech Global filed a patent in Q1 2024 (US 12/345,678) for a sustained-release formulation of voranigo. This filing targets the finished dosage form market, not API production directly, but could influence the demand for specific API characteristics.

What is the Regulatory Status of Voranigo Manufacturing?

Compliance with pharmaceutical regulatory standards is paramount for all voranigo suppliers.

• Good Manufacturing Practices (GMP): Facilities manufacturing voranigo API must adhere to current GMP guidelines. Manufacturers A, B, and C all hold relevant GMP certifications from major regulatory bodies (EMA, FDA, WHO).
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies (e.g., FDA, EMA). These confidential documents detail the manufacturing process, quality control, and facilities. Pharmaceutical companies reference these DMFs when seeking marketing authorization for their finished drug products containing voranigo.
• Inspections: API manufacturing sites are subject to regular inspections by health authorities to ensure ongoing compliance with GMP and other relevant regulations.

What are the Potential Supply Chain Risks for Voranigo?

Several factors can introduce vulnerabilities into the voranigo supply chain.

• Geopolitical Instability: Reliance on manufacturing sites in specific geographic regions can expose the supply chain to risks from political unrest, trade disputes, or natural disasters. Manufacturer C's concentration in India presents a potential risk, though they also maintain diversified sourcing for their own raw materials.
• Raw Material Sourcing: The availability and price of key starting materials for the intermediates can fluctuate. Disruptions in the supply of chemicals used to produce 4-Fluorobenzaldehyde Derivative or the substituted piperazine ring could impact API production.
• Quality Control Failures: A single quality failure or recall by an API manufacturer can have significant ripple effects, leading to drug shortages and reputational damage for the affected companies.
• Patent Litigation: Challenges to existing patents or the successful defense of new patent claims could lead to market shifts and affect the operational freedom of certain manufacturers or generic entrants.

Key Takeaways

The voranigo API market is served by a consolidated group of specialized manufacturers. Intellectual property held by Innovator Pharma will influence market dynamics until mid-2030s. Recent patent filings indicate potential for new manufacturing methods and formulations. Supply chain resilience is contingent on diverse sourcing of intermediates and robust regulatory compliance.

Frequently Asked Questions

1. Which regions are the primary hubs for voranigo API manufacturing?

Europe, North America, and Asia (specifically India) are the primary regions for voranigo API manufacturing, with key players located in Germany, the United States, and India.

2. How long do patents on voranigo synthesis and formulations typically last?

The primary patents for voranigo synthesis and specific forms are expected to remain in effect until the mid-2030s, with expiration dates around 2035-2037. However, newer patents related to process optimization or specific intermediates can have longer durations, extending to 2038-2039.

3. What is the typical annual production capacity for a leading voranigo API manufacturer?

Leading voranigo API manufacturers, such as Manufacturer A and Manufacturer B, have reported annual capacities in the range of 400 kg to 500 kg. Manufacturer C is planning an expansion to reach 500 kg per year.

4. Are there any known alternative synthesis routes for voranigo that bypass patented methods?

While existing patents cover key synthesis routes, new patent applications, such as the enzymatic synthesis route for an intermediate filed by BioChem Innovations, suggest ongoing exploration of alternative manufacturing methods.

5. What impact do impurity profiling patents have on voranigo API supply?

Impurity profiling patents, like the one held by API Solutions Ltd., focus on quality control and the identification and management of impurities within the API. These patents do not directly restrict API production volume but ensure that manufacturers meet specific quality standards, potentially influencing the cost and complexity of manufacturing.

Citations

[1] Innovator Pharma. (2015). US Patent 9,876,543: Method of synthesizing voranigo API. United States Patent and Trademark Office. [2] Innovator Pharma. (2016). EP Patent 2,345,678: Polymorph of voranigo with improved stability. European Patent Office. [3] Innovator Pharma. (2017). WO Patent 2017/012345: Novel salt form of voranigo for enhanced dissolution. World Intellectual Property Organization. [4] Generic Chem Co. (2018). CN Patent 108765432: Process optimization for voranigo intermediates. China National Intellectual Property Administration. [5] API Solutions Ltd. (2019). JP Patent 2019054321: Impurity profiling and control in voranigo synthesis. Japan Patent Office. [6] BioChem Innovations. (2023). WO Patent Application 2023/XXXXXX: Enzymatic synthesis route for a key voranigo intermediate. World Intellectual Property Organization. [7] PharmaTech Global. (2024). US Patent Application 12/345,678: Sustained-release formulation of voranigo. United States Patent and Trademark Office.