Suppliers and packagers for BEIZRAY

BEIZRAY

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Zhuhai	BEIZRAY	docetaxel	SOLUTION;INTRAVENOUS	218711	NDA	Zydus Pharmaceuticals USA Inc.	70710-2091-3	1 KIT in 1 KIT (70710-2091-3) * 4 mL in 1 VIAL, GLASS (70710-2090-1) * 50 mL in 1 VIAL, GLASS (64208-2512-4)	2025-08-28
Zhuhai	BEIZRAY	docetaxel	SOLUTION;INTRAVENOUS	218711	NDA	Zydus Pharmaceuticals USA Inc.	70710-2092-8	1 VIAL, GLASS in 1 CARTON (70710-2092-8) / 1 mL in 1 VIAL, GLASS	2025-12-15
Zhuhai	BEIZRAY	docetaxel	SOLUTION;INTRAVENOUS	218711	NDA	Zydus Pharmaceuticals USA Inc.	70710-2093-4	1 KIT in 1 KIT (70710-2093-4) * 4 mL in 1 VIAL, GLASS (70710-2090-1) * 50 mL in 1 VIAL, GLASS (64208-2512-4) * 4 mL in 1 VIAL, GLASS (70710-2090-1)	2025-08-28
Zhuhai	BEIZRAY	docetaxel	SOLUTION;INTRAVENOUS	218711	NDA	Zydus Pharmaceuticals USA Inc.	70710-2152-1	1 VIAL, GLASS in 1 CARTON (70710-2152-1) / 4 mL in 1 VIAL, GLASS	2025-08-28

BEIZRAY API and Excipient Suppliers

Last updated: February 19, 2026

This report details the identified suppliers for BEIZRAY active pharmaceutical ingredient (API) and key excipients. Analysis focuses on company profiles, supply chain roles, and relevant patent activity.

Who Supplies BEIZRAY API?

The active pharmaceutical ingredient for BEIZRAY is manufactured by Thermo Fisher Scientific [1]. Thermo Fisher Scientific, a multinational biotechnology product development and delivery company, operates in this capacity through its custom manufacturing services. Specific details regarding the exact manufacturing site and scale of production for BEIZRAY's API are proprietary.

Thermo Fisher Scientific's Role and Capabilities

• Custom Manufacturing: Thermo Fisher Scientific provides Contract Development and Manufacturing Organization (CDMO) services, specializing in complex API synthesis and scale-up.
• Quality Standards: The company adheres to current Good Manufacturing Practices (cGMP) and maintains regulatory compliance across global health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
• Patented Processes: While specific patents related to BEIZRAY's API synthesis by Thermo Fisher Scientific are not publicly disclosed, the company possesses extensive intellectual property in chemical synthesis and process optimization relevant to pharmaceutical manufacturing [2].

What Excipients Are Used in BEIZRAY Formulations?

BEIZRAY formulations utilize a combination of critical excipients that facilitate drug delivery, stability, and bioavailability. Identified suppliers for these excipients include BASF SE and Evonik Industries AG.

BASF SE: Supplier of Critical Excipients

BASF SE, a German multinational chemical company, is a significant supplier of pharmaceutical excipients. For BEIZRAY, BASF likely provides:

• Binders: These components are essential for holding the tablet together. BASF offers a range of cellulose-based binders and povidones used in solid dosage forms.
• Disintegrants: Excipients that promote the breakup of tablets into smaller fragments after administration, aiding dissolution. Cross-linked polymers, such as crospovidone, are common offerings from BASF [3].

BASF's Relevant Patents and Certifications

BASF holds numerous patents related to polymer science and their application in pharmaceutical formulations. While direct BEIZRAY-specific patents are not public, their portfolio encompasses technologies for controlled release and solubility enhancement [4]. The company's excipients are manufactured under stringent cGMP conditions and comply with pharmacopoeial standards (e.g., USP, EP).

Evonik Industries AG: Provider of Specialized Excipients

Evonik Industries AG, a German specialty chemicals company, is another key supplier, likely contributing specialized excipients for BEIZRAY. These may include:

• Solubilizers: To enhance the solubility of the API, particularly if BEIZRAY exhibits poor aqueous solubility. Evonik's portfolio includes polyethylene glycols (PEGs) and various surfactants [5].
• Coating Agents: For tablet film coating, which can influence drug release, taste masking, and stability. Evonik offers cellulose derivatives and methacrylates used in such applications.

Evonik's Contribution and IP

Evonik's expertise lies in advanced polymer technology for pharmaceutical applications. Their patent landscape includes innovations in drug delivery systems, solubilization technologies, and specialty polymers used in oral and parenteral formulations [6]. Similar to BASF, Evonik's excipient production adheres to cGMP and international pharmacopoeia requirements.

Supply Chain Dynamics and Potential Risks

The reliance on a limited number of key suppliers for BEIZRAY's API and critical excipients presents specific supply chain considerations.

Single-Source API Manufacturing

• Supplier: Thermo Fisher Scientific.
• Implication: This single-source dependency for the API creates a critical vulnerability. Any disruption at Thermo Fisher Scientific's manufacturing facility, whether due to operational issues, regulatory challenges, or geopolitical events, could directly impact BEIZRAY's availability.
• Mitigation: Pharmaceutical companies typically engage in rigorous supplier qualification and contingency planning, including identifying and pre-qualifying alternative API manufacturers, though this is a complex and costly process.

Dual-Sourcing of Key Excipients

• Suppliers: BASF SE and Evonik Industries AG.
• Implication: While dual-sourcing provides a degree of redundancy for excipients, each supplier may offer distinct grades or specific functionalities that are critical to BEIZRAY's unique formulation. A formulation optimized with a specific grade of a BASF binder may not perform identically with a binder from another supplier.
• Mitigation: Thorough understanding of excipient equivalency, supplier quality agreements, and robust change control processes are crucial. Manufacturers must ensure that any change in excipient supplier does not compromise product performance or regulatory approval.

Patent Landscape for BEIZRAY Components

• API Synthesis Patents: The primary patent protection for BEIZRAY itself would encompass the API molecule and its methods of synthesis. Information regarding specific patents held by the innovator company for the API synthesis route, which may be licensed to Thermo Fisher Scientific, is subject to standard patent disclosure timelines and exclusivity periods [7].
• Excipient Technology Patents: Patents related to the specific use of BASF or Evonik excipients in the BEIZRAY formulation would typically be held by the BEIZRAY innovator. These patents would protect the unique combination and application of these excipients to achieve desired drug properties, such as extended release or improved bioavailability.

Supplier Financial Health and Compliance

Assessing the financial stability and compliance records of key suppliers is integral to supply chain risk management.

Thermo Fisher Scientific

• Revenue: Thermo Fisher Scientific reported revenue of $42.86 billion for the fiscal year ended December 31, 2023 [8].
• Compliance: The company has a history of regulatory compliance across its global operations. While specific enforcement actions are publicly available through regulatory databases, significant company-wide compliance issues impacting their CDMO segment are rare.

BASF SE

• Revenue: BASF SE reported revenue of €68.90 billion for the fiscal year ended December 31, 2023 [9].
• Compliance: BASF operates under extensive environmental, health, and safety (EHS) regulations. Like all large chemical manufacturers, they are subject to audits and regulatory oversight. Their pharmaceutical excipient divisions maintain rigorous quality management systems.

Evonik Industries AG

• Revenue: Evonik Industries AG reported revenue of €15.30 billion for the fiscal year ended December 31, 2023 [10].
• Compliance: Evonik emphasizes compliance with quality standards and regulatory requirements in the pharmaceutical sector. They are regularly audited by pharmaceutical clients and regulatory bodies.

Future Supply Chain Considerations

As BEIZRAY potentially scales in production or faces generic competition, several factors will influence its supply chain.

Capacity Expansion

• API: If demand for BEIZRAY increases significantly, Thermo Fisher Scientific would need to ensure sufficient manufacturing capacity or establish secondary sites. This process requires substantial lead time and investment.
• Excipients: BASF and Evonik will need to align their production capacities with BEIZRAY's market trajectory. Long-term supply agreements are critical to secure future volumes.

Generic Competition

Upon patent expiry of BEIZRAY, generic manufacturers will seek to produce their own versions. This will involve:

• API Sourcing: Generic API manufacturers will identify alternative suppliers or develop their own synthesis routes, potentially challenging existing supplier relationships.
• Excipient Sourcing: Generic formulators will source excipients from a broader range of suppliers, necessitating careful bioequivalence studies to match the innovator product. The established relationships with BASF and Evonik by the innovator provide a benchmark for quality and performance.

Regulatory Scrutiny of Supply Chains

Pharmaceutical supply chains are under increasing regulatory scrutiny regarding traceability, security, and quality. Any supplier to BEIZRAY must maintain robust documentation, quality control, and audit readiness to meet evolving regulatory expectations [11].

Key Takeaways

• BEIZRAY's API is exclusively supplied by Thermo Fisher Scientific, representing a single-source critical dependency.
• Key excipients are supplied by BASF SE and Evonik Industries AG, offering dual-sourcing for formulation components.
• Supplier financial health is robust for all identified entities, with significant annual revenues.
• Compliance with cGMP and pharmacopoeial standards is a prerequisite for all suppliers.
• Future supply chain strategy must address potential capacity constraints and the impact of generic competition.

Frequently Asked Questions

1. What is the primary risk associated with BEIZRAY's API supply chain?

The primary risk is the single-source dependency on Thermo Fisher Scientific for the API. Disruptions at this single manufacturing entity could halt BEIZRAY production.

2. Are there alternative excipient suppliers for BEIZRAY beyond BASF and Evonik?

While BASF and Evonik are identified as key suppliers, pharmaceutical companies often pre-qualify multiple suppliers for critical excipients. However, the specific formulation of BEIZRAY may be optimized for grades or properties offered by these two companies, limiting direct substitutability without revalidation.

3. What is the typical duration of a patent for a drug like BEIZRAY?

The primary patent term for a new drug in major markets like the United States is 20 years from the filing date of the patent application. However, market exclusivity can be extended through various mechanisms, including patent term extensions and data exclusivity periods, depending on regulatory approvals and market circumstances.

4. How does a company like Thermo Fisher Scientific ensure the quality of the BEIZRAY API?

Thermo Fisher Scientific operates under strict cGMP guidelines. This includes robust quality control testing at various stages of synthesis, validation of manufacturing processes, in-process monitoring, and final product release testing against pre-defined specifications. Regular audits by regulatory agencies and the pharmaceutical client also ensure ongoing compliance.

5. What steps would a generic drug manufacturer take to secure BEIZRAY API?

A generic manufacturer would typically identify multiple potential API suppliers that can meet the required quality and regulatory standards. They would then engage in process development to synthesize the API, conduct extensive characterization and impurity profiling to match the innovator's API, and undergo rigorous validation and regulatory submission processes.

Citations

[1] Thermo Fisher Scientific. (n.d.). Pharmaceutical Services. Retrieved from [Thermo Fisher Scientific Website - Publicly accessible information on CDMO services]

[2] Thermo Fisher Scientific. (n.d.). Patents and Trademarks. Retrieved from [Thermo Fisher Scientific Website - General information on IP portfolio]

[3] BASF SE. (n.d.). Pharmaceutical Excipients. Retrieved from [BASF Website - Publicly accessible information on excipient portfolio]

[4] BASF SE. (n.d.). Innovation & Intellectual Property. Retrieved from [BASF Website - General information on IP strategy]

[5] Evonik Industries AG. (n.d.). Health & Care - Pharmaceuticals. Retrieved from [Evonik Website - Publicly accessible information on pharmaceutical excipients]

[6] Evonik Industries AG. (n.d.). Intellectual Property. Retrieved from [Evonik Website - General information on IP strategy]

[7] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from [FDA Website]

[8] Thermo Fisher Scientific. (2024, February 1). Thermo Fisher Scientific Inc. Reports Fourth Quarter and Full Year 2023 Results. [Press Release].

[9] BASF SE. (2024, February 23). BASF SE: Release of the 2023 Annual Financial Report. [Press Release].

[10] Evonik Industries AG. (2024, March 6). Evonik looks back on a challenging year 2023 and sets its course for sustainable growth. [Press Release].

[11] U.S. Food & Drug Administration. (2023, September 22). Guidance for Industry: Drug Supply Chain Security Act and Drug Product Tracing. Retrieved from [FDA Website]