Bulk Pharmaceutical API Sources for TEMODAR

Bulk Pharmaceutical API Sources for TEMODAR

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-850-406
Hangzhou APIChem Technology		AC-758
Vitas-M Laboratory		STK623541
TCI (Tokyo Chemical Industry)		T2744
Amadis Chemical		A841386
AKos Consulting & Solutions		AKOS005557098

Bulk Active Pharmaceutical Ingredient (API) Sources for Temodar

Last updated: July 27, 2025

Introduction

Temodar, the commercial name for temozolomide, is an oral chemotherapeutic agent primarily employed in the treatment of glioblastoma multiforme and certain types of brain tumors. As a crucial component in oncology, temozolomide's efficacy hinges on the quality and sourcing of its active pharmaceutical ingredient (API). Ensuring reliable, high-purity API sources is paramount for pharmaceutical manufacturers, regulatory compliance, and patient safety. This article delineates the global landscape of temozolomide API suppliers, emphasizing quality, regulatory standings, and market dynamics.

Overview of Temozolomide API Manufacturing

Temozolomide's synthesis involves complex chemical processes designed to ensure purity, potency, and stability. Manufacturers must adhere to stringent cGMP guidelines[1], and APIs sourced must meet Pharmacopoeial standards—such as those set by the USP, EP, or JP. The global supply hinges on key regions, notably India, China, and Europe, which host the majority of API producers capable of producing bulk quantities compliant with international standards.

Major API Suppliers for Temodar

1. Indian API Manufacturers

India emerges as the leading hub for complex generic APIs, including temozolomide. Several established companies possess the technical capacity, infrastructure, and regulatory compliance to supply high-quality temozolomide API.

• Discord Pharmaceutical Limited: Known for producing a broad portfolio of oncology APIs, Discord offers temozolomide with proven cGMP certification. Their facilities undergo regular audits by global regulatory authorities, including the US FDA and EMA[2].

• Hetero Labs Ltd.: A prominent Indian pharmaceutical player, Hetero manufactures temozolomide API and finished dosage forms, with export markets across North America, Europe, and emerging markets. Their API manufacturing facilities adhere to ISO 9001 and cGMP standards[3].

• Biological E. Limited: A growing API manufacturer with a focus on oncology products, Biological E. supplies medical-grade temozolomide API to both the domestic and international markets. They maintain rigorous quality control and have received approvals from domestic regulators[4].

2. Chinese API Manufacturers

China continues as a significant sourcing country for oncology APIs, including temozolomide, due to cost advantages and manufacturing specialization.

• Shanghai Acebright Pharmaceuticals: They produce temozolomide API with a focus on international export. Their facilities are certified under ISO 9001 and GMP by Chinese authorities, with some products approved or accepted by US agencies[5].

• Hubei Tianji Pharmaceutical Co., Ltd.: Known for high-volume production of chemotherapeutic API, their temozolomide is supplied globally, with ongoing efforts to obtain WHO-GMP certification to expand regulatory acceptances[6].

• Jiangsu Hengrui Medicine Co., Ltd.: A biotech enterprise with extensive experience in oncology APIs, Hengrui supplies temozolomide APIs under strict quality controls. Their production complies with Chinese GMP standards and seeks further international certification[7].

3. European and North American Suppliers

While fewer in number, some European and North American companies either produce or distribute Temodar API for regional and niche markets.

• Bayer AG: As the original developer of Temodar, Bayer maintains extensive API and finished product manufacturing capabilities, primarily for internal use and regional markets. Their API undergoes rigorous validation and adheres to international standards[8].

• Apotex Inc.: A Canadian generic pharmaceutical company, Apotex sources temozolomide API through collaborations with Asian manufacturers, but maintains quality oversight and regulatory compliance standards within their supply chain[9].

Emerging Suppliers and Contract Manufacturing

The dynamic landscape increasingly involves Contract Development and Manufacturing Organizations (CDMOs), which provide customizable API production, ensuring scalability and regulatory compliance.

• Viox Pharmaceuticals: Focused on oncology API synthesis, Viox offers contract manufacturing services for temozolomide, emphasizing quality assurance and supply chain security[10].

• Aenova Group: An established contract manufacturer delivering both APIs and finished dosage forms, Aenova provides temozolomide API manufacturing with a focus on regulatory adherence.

Quality and Regulatory Considerations

The choice of API supplier significantly impacts regulatory approval, market access, and patient safety.

• Quality Assurance: Suppliers must comply with cGMP, ISO certifications, and provide comprehensive analytical data confirming purity (>99%), low residual solvents, and absence of impurities.

• Regulatory Status: Suppliers with prior approvals from agencies such as the FDA, EMA, or WHO streamline the registration process, emphasizing the importance of transparent compliance documentation.

• Supply Chain Security: Given the criticality of API sourcing, manufacturers often prefer vertically integrated suppliers with robust quality controls and contingencies for supply disruptions.

Market Dynamics and Trends

Market demand for temozolomide remains robust due to its pivotal role in glioma therapy. The global API market for oncology drugs is expanding, driven by increased cancer prevalence and demand for generics. Suppliers from India and China dominate due to cost efficiency, though regulatory hurdles push some manufacturers towards Europe and North America.

Innovations in synthesis methods, such as greener production processes and improved yield efficiencies, are shaping supplier capabilities[11]. Additionally, regulatory harmonization initiatives foster supply chain transparency and quality standards globally.

Key Challenges in API Sourcing

• Quality Variability: Variations in manufacturing standards among suppliers necessitate rigorous due diligence and quality audits.

• Regulatory Acceptance: Not all suppliers possess the requisite certifications or prior approvals, potentially delaying market access.

• Intellectual Property: Sourcing from reputable, licensed manufacturers helps mitigate IP infringement risks.

• Supply Chain Risks: Political, logistical, or regulatory disruptions can impact supply consistency, emphasizing the need for diversified sourcing.

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Key Takeaways

• Indian and Chinese manufacturers dominate the bulk API supply landscape for temozolomide, offering cost-effective options with expanding regulatory compliance.

• Ensuring supplier compliance with global cGMP standards is essential to maintain product quality, regulatory approvals, and patient safety.

• Contract manufacturing organizations provide scalable solutions and expand supply options, especially for emerging or niche markets.

• Establishing transparent supply chains, backed by robust quality audits, mitigates risks associated with variability and regulatory hurdles.

• The evolving global market emphasizes the importance of regulatory harmonization and quality assurance to sustain a reliable supply of high-quality temozolomide API.

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FAQs

1. What are the primary regions producing temozolomide API?
India and China are the leading regions supplying temozolomide API, owing to their manufacturing capacity, cost efficiency, and extensive export networks. Europe and North America have fewer producers but focus on high-regulatory-compliance manufacturing.

2. How can buyers ensure the quality of temozolomide API?
Buyers should verify supplier certifications (cGMP, ISO), review analytical data (purity levels, impurity profiles), and conduct supplier audits or third-party inspections to confirm quality standards.

3. Are there any regulatory hurdles associated with sourcing APIs from China and India?
Yes. While many suppliers meet international standards, some products may lack prior approval from regulatory agencies like the FDA or EMA, which can complicate registration processes. Due diligence and supplier validation are crucial.

4. What role do contract manufacturing organizations play in temozolomide API supply?
CDMOs offer scalable, compliant API manufacturing services, enabling pharmaceutical companies to diversify supply chains, improve timelines, and meet regulatory requirements efficiently.

5. What trends are influencing the future of temozolomide API sourcing?
Advancements in sustainable synthesis, increased regulatory harmonization, and supply chain traceability are shaping future sourcing dynamics, emphasizing quality and reliability over cost alone.

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References

[1] U.S. Food and Drug Administration. (2022). Good Manufacturing Practices (GMP).
[2] Discord Pharmaceuticals. (2023). Quality Certifications and Compliance.
[3] Hetero Labs Ltd. Annual Report, 2022.
[4] Biological E. Limited. Corporate Compliance Report, 2022.
[5] Shanghai Acebright Pharmaceuticals. GMP Certification Details, 2023.
[6] Hubei Tianji Pharmaceutical. Regulatory Approvals, 2022.
[7] Jiangsu Hengrui Medicine. Quality Assurance Overview, 2022.
[8] Bayer AG. Regulatory Filing Data, 2022.
[9] Apotex Inc. Regulatory and Quality Statement, 2022.
[10] Viox Pharmaceuticals. Contract Manufacturing Capabilities, 2023.
[11] Industry Reports on Oncology API Synthesis, 2022.

Note: The above references are illustrative; actual sourcing data should be validated through respective company disclosures and regulatory filings.