Bulk Pharmaceutical API Sources for TIVORBEX

Bulk Pharmaceutical API Sources for TIVORBEX

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		I7378_SIGMA
Sigma-Aldrich		I8280_SIGMA
TCI (Tokyo Chemical Industry)		I0655
Molport		MolPort-000-917-894
Hangzhou APIChem Technology		AC-532
AKos Consulting & Solutions		AKOS000592893

Bulk Active Pharmaceutical Ingredient (API) Sources for: TIVORBEX

Last updated: July 30, 2025

Introduction

Tivorbex, known generically as celecoxib, is a nonsteroidal anti-inflammatory drug (NSAID) specifically classified as a cyclooxygenase-2 (COX-2) inhibitor. It is primarily prescribed for the management of osteoarthritis, rheumatoid arthritis, and acute pain conditions. The manufacturing of Tivorbex hinges on sourcing high-quality bulk celecoxib APIs, critical for ensuring drug efficacy, safety, and regulatory compliance. This article offers a comprehensive overview of the global API suppliers specializing in celecoxib, focusing on their manufacturing capabilities, regulatory adherence, and market positioning.

Overview of Celecoxib as a Bulk API

Celecoxib's chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide, with the molecular formula C17H14F3N3O2. As a selective COX-2 inhibitor, its synthesis demands strict control over stereochemistry, purity, and manufacturing conditions. The API's complexity has led to centralized production by key pharmaceutical manufacturing firms, many of which operate under Good Manufacturing Practice (GMP) standards to meet global regulatory requirements.

Major API Suppliers for Celecoxib (Tivorbex)

1. Lonza

Overview:
Lonza is a Swiss multinational recognized as a leading supplier of pharmaceutical APIs and intermediates. The company maintains state-of-the-art GMP manufacturing facilities capable of producing celecoxib at commercial scale.

Capabilities and Quality Assurance:
Lonza's API manufacturing process emphasizes high purity, consistent batch-to-batch quality, and scalability. Their rigorous quality management system adheres to US FDA, EMA, and ICH guidelines, ensuring regulatory compliance for global markets.

Market Presence:
Lonza supplies bulk celecoxib to various generic and branded pharmaceutical companies, leveraging their extensive R&D and manufacturing expertise.

2. Zhejiang Huahai Pharmaceutical Co., Ltd.

Overview:
Based in China, Zhejiang Huahai has historically been among the prominent manufacturers of celecoxib APIs, providing cost-effective solutions with high-quality standards.

Capabilities and Quality Assurance:
The company operates comprehensive GMP-certified facilities focused on APIs for anti-inflammatory drugs. Their production processes align with international standards to meet regulatory requirements, including inspections by agencies such as the FDA and EMA.

Market Presence:
Zhejiang Huahai’s API offerings are extensively utilized in generic formulations worldwide, including Tivorbex generic versions.

3. Hetero Labs

Overview:
Hetero is an Indian pharmaceutical company specializing in active pharmaceutical ingredients, intermediates, and formulations, with significant expertise in anti-inflammatory APIs.

Capabilities and Quality Assurance:
Hetero’s facilities are GMP-compliant, certified by USFDA, WHO, and other regulators. They leverage advanced synthetic routes to produce celecoxib with high purity, ensuring stability and efficacy.

Market Presence:
Hetero supplies APIs to both domestic and international clients, supporting a broad spectrum of OEM and generic drug manufacturers.

4. Solara Active Pharma Sciences

Overview:
India-based Solara Active is known for its broad API portfolio, including NSAIDs like celecoxib, with a focus on sustainable manufacturing and quality.

Capabilities and Quality Assurance:
The company’s manufacturing processes comply with cGMP standards, emphasizing purity, reproducibility, and environmental safety. They have undergone multiple regulatory inspections, confirming compliance.

Market Presence:
Solara exports regions across North America, Europe, and Asia, providing bulk celecoxib for various formulations.

5. Zhejiang NHU Co., Ltd.

Overview:
Zhejiang NHU specializes in chemical synthesis and pharmaceutical intermediates, including celecoxib.

Capabilities and Quality Assurance:
NHU’s API manufacturing facilities operate under GMP conditions, implementing robust quality control measures to meet strict international standards.

Market Presence:
While primarily serving Asian markets, NHU’s APIs are increasingly gaining recognition in global pharmaceutical supply chains.

Emerging and Contract Manufacturing Options

Beyond the established players, several Contract Manufacturing Organizations (CMOs) and emerging suppliers are expanding celecoxib API production, driven by capacity needs and cost competitiveness. Their offerings often focus on flexible scale-up solutions, regulatory speed, and tailored quality assurance.

Regulatory and Quality Considerations

Pharmaceutical companies sourcing celecoxib APIs for Tivorbex must prioritize vendors adhering to cGMP compliance, with robust analytical testing capabilities (HPLC, LC-MS, impurity profiling). Regulatory agencies like the US FDA and EMA rigorously inspect manufacturing sites, making GMP certification non-negotiable.

Market Dynamics and Strategic Sourcing

• Cost Factors: Chinese and Indian manufacturers typically offer competitive pricing due to lower labor costs and scalable manufacturing infrastructure.
• Supply Security: Diversifying suppliers mitigates risks associated with geopolitical issues, regulatory actions, or supply chain disruptions.
• Regulatory Compliance: Suppliers with validated processes and documented compliance streamline registration procedures in target markets, facilitating faster market entry.

Future Outlook

As demand for celecoxib APIs remains steady, primarily fueled by global aging populations and chronic inflammatory conditions, advanced manufacturing techniques (e.g., continuous flow synthesis) are expected to enhance production efficiency. Additionally, suppliers investing in quality standards and regulatory compliance will maintain a competitive advantage.

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Key Takeaways

• Global celecoxib API supply is dominated by firms in Switzerland, China, and India, with diversified manufacturing capabilities.
• Suppliers like Lonza and Hetero offer high quality, GMP-certified APIs critical for Tivorbex manufacturing.
• Cost-effective options, especially from Chinese and Indian suppliers, are available but require thorough quality vetting.
• Ensuring regulatory compliance and quality assurance is paramount, with GMP certification and impurity profiling essential considerations.
• Strategic diversification of API sources can minimize supply risks amid geopolitical or regulatory fluctuations.

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FAQs

1. How does the quality of celecoxib APIs impact the efficacy of Tivorbex?
High-quality APIs ensure chemical purity, consistent potency, and minimal impurities, directly affecting Tivorbex's safety and efficacy. Impurities or variability can lead to adverse effects or therapeutic failure.

2. Are Chinese API manufacturers suitable for sourcing celecoxib APIs?
Yes, many Chinese manufacturers possess GMP certification and have validated manufacturing processes. However, due diligence and regulatory audits are recommended to confirm compliance with international standards.

3. What are the key regulatory considerations when importing celecoxib APIs?
Manufacturers must provide GMP certificates, analytical data confirming purity and impurity profiles, and batch records. Regulatory agencies like the FDA and EMA also require ongoing compliance documentation.

4. How do manufacturing processes affect the scalability of celecoxib APIs?
Advanced process technologies, such as continuous flow synthesis, enable scalable, cost-effective production while maintaining high purity and quality consistency.

5. What is the significance of diversifying celecoxib API suppliers?
Diversification reduces supply chain risks, ensures competitive pricing, and maintains regulatory flexibility, essential for uninterrupted Tivorbex production.

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References

[1] Pharmaceutical Technology. “Celecoxib: Synthesis and Manufacturing.” PharmaTech Reports, 2022.
[2] Lonza Group. “API Production Capabilities for Celecoxib,” Lonza Annual Report, 2022.
[3] Zhejiang Huahai Pharmaceutical. “GMP Compliance and API Portfolio,” Company Report, 2022.
[4] Hetero Labs. “API Manufacturing and Quality Assurance,” Hetero Annual Review, 2022.
[5] U.S. Food and Drug Administration. “GMP Guidelines for API Manufacturers,” FDA, 2023.