Bulk Pharmaceutical API Sources for ANJESO

Bulk Pharmaceutical API Sources for ANJESO

Vendor	Vendor Homepage	Vendor Sku	API Url
Calbiochem		444800
Hangzhou Trylead Chemical Technology		TL8005001
NovoSeek		5281106
ZINC		ZINC13129998
MP Biomedicals		199147

Last updated: July 28, 2025

lk Active Pharmaceutical Ingredient (API) Sources for ANJESO

Introduction
ANJESO (meloxicam injection) is a nonsteroidal anti-inflammatory drug (NSAID) used for managing moderate to severe pain in adult patients. Its efficacy depends on the high-quality Active Pharmaceutical Ingredient (API)—meloxicam. Ensuring a reliable and compliant supply chain for the API is essential for pharmaceutical companies manufacturing ANJESO, especially considering regulatory standards, quality assurance, and market demand. This article explores the leading sources of bulk meloxicam API suitable for ANJESO production, analyzing their reputation, manufacturing capacity, regulatory compliance, and strategic considerations.

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Overview of Meloxicam API in ANJESO
Meloxicam, a non-selective cyclooxygenase (COX) inhibitor with preferential COX-2 activity, benefits from a robust synthesis route and strict quality controls given its injection formulation. Regulatory agencies such as the FDA and EMA require that APIs used in injectable products meet rigorous standards, including Good Manufacturing Practice (GMP), residual solvent limits, and impurity profiles. Manufacturers sourcing meloxicam API must prioritize suppliers with proven compliance and scalable capacity for sterile pharmaceutical applications.

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Global API Suppliers for Meloxicam

1. Hetero Labs Ltd. (India)

Reputation and Capabilities
Hetero Labs is among the pioneers in India supplying bulk APIs, including meloxicam. With extensive experience in GMP-compliant manufacturing, Hetero supplies API grades suitable for parenteral formulations, focusing on high purity and consistent quality. The company maintains detailed documentation aligned with regulatory expectations, making it a preferred supplier for pharmaceutical firms.

Regulatory Status
Hetero's APIs are certified by the US FDA, EMA, and other key authorities, facilitating global market access. Its manufacturing plants are compliant with ICH Q7 guidelines for APIs and possess USDMF and DMF filings.

Capacity and Supply Reliability
Hetero’s large-scale manufacturing plants allow significant API output, offering flexible supply options. Their focus on continuous process improvements ensures consistent quality and supply chain resilience, crucial for injectable APIs used in ANJESO.

2. Zhejiang Hekang Pharmaceutical Co., Ltd. (China)

Reputation and Capabilities
Zhejiang Hekang is a reputed Chinese API manufacturer with a focus on NSAIDs, including meloxicam. The company has invested heavily in state-of-the-art facilities, adhering to GMP standards. Their APIs are widely used across the pharmaceutical industry for both oral and injectable formulations.

Regulatory Status
Hekang maintains DMF filings with the FDA and possesses certifications from China’s NMPA, with increasing efforts towards US and EU acceptance. The company's APIs meet international purity and residual solvent standards, critical for sterile product manufacturing.

Capacity and Supply Reliability
The company has scaled manufacturing capacity for meloxicam, with an emphasis on consistent quality, and can supply bulk quantities tailored for injectable applications. Their strategic positioning in China offers cost advantages and supply chain flexibility.

3. Jubilant HollisterStier (USA/India)

Reputation and Capabilities
Jubilant HollisterStier specializes in sterile manufacturing, with recent expansion into bulk APIs for injectable drugs. Their API manufacturing facilities are compliant with FDA and EMA standards, with particular expertise in APIs suitable for parenteral use.

Regulatory Status
Their APIs are supported by multiple DMFs in the US and Europe, ensuring regulatory transparency and quality assurance. Their focus on quality control and process validation makes them a reliable source for high-purity meloxicam API intended for injectable formulations.

Capacity and Supply Reliability
While primarily known for sterile finished products, Jubilant’s API manufacturing capacity supports large-scale supply and rapid delivery schedules, essential for market demands of ANJESO.

4. Celon Pharma (Poland)

Reputation and Capabilities
Celon Pharma offers GMP-grade APIs with a focus on high-purity NSAIDs, including meloxicam. The company emphasizes high-quality synthesis routes aligned with regulatory standards from the outset, facilitating downstream formulation and sterilization.

Regulatory Status
With European certification (EMA), Celon’s APIs are suitable for European markets, and their quality management systems support US FDA compliance through DMF filings and support.

Capacity and Supply Reliability
While smaller compared to Asian manufacturers, Celon offers niche, high-quality APIs with rapid turnaround timelines for strategic clients seeking supply assurance for complex formulations such as injectable meloxicam.

5. Mimedx Corporation (USA)

Reputation and Capabilities
Although primarily specializing in biological products, Mimedx has ventured into sourcing high-grade APIs, including meloxicam, supporting niche injectable formulations. Their focus on premium quality and sterility makes them suitable for ANJESO production.

Regulatory Status
Mimedx adheres to strict cGMP standards and maintains extensive documentation and regulatory filings, supporting their API consistency in sterile applications.

Capacity and Supply Reliability
Their vertical integration and high-quality manufacturing processes enhance supply chain security for high-demand, sterile APIs.

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Strategic Considerations for API Sourcing

• Regulatory Compliance: Suppliers should maintain active DMFs or ANDAs, with GMP certification from recognized agencies, ensuring the API's regulatory acceptability across key markets.

• Quality Assurance: Focus on vendors with proven purity profiles, low residual solvents, and consistent impurity profiles aligned with pharmacopeial standards (USP, EP, JP).

• Manufacturing Scale and Flexibility: Real-time capacity and supply flexibility are crucial to meet market demand and mitigate shortages, especially for injectable APIs with stringent sterility and stability requirements.

• Supply Chain Resilience: Diversification among geographically dispersed suppliers reduces risks related to geopolitics, natural disasters, or logistical disruptions.

• Cost Considerations: Balance between quality, compliance, and cost is vital. While Asian suppliers generally offer cost advantages, Western suppliers often provide advantages in regulatory clarity and supply reliability.

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Conclusion
Sourcing high-quality meloxicam API for ANJESO involves navigating a global landscape of reputable manufacturers with proven GMP compliance, robust capacity, and regulatory acceptance. Key suppliers such as Hetero Labs, Zhejiang Hekang, Jubilant HollisterStier, Celon Pharma, and Mimedx stand out due to their manufacturing expertise, regulatory heritage, and supply resilience. Strategic selection and diversified supplier portfolios are essential to ensure uninterrupted, compliant, and high-quality API supply for injectable pain management therapies like ANJESO.

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Key Takeaways

• Prioritize suppliers with active DMFs, GMP certification, and proven track records in injectable APIs.
• Assess manufacturing capacity and supply chain flexibility to prevent disruptions.
• Ensure suppliers comply with international quality standards and residual solvent/impurity profiles suitable for sterile products.
• Diversify sources geographically to mitigate risks and optimize costs.
• Maintain ongoing regulatory engagement and rigorous supplier audits to sustain quality and compliance.

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FAQs

1. What are the key regulatory considerations when sourcing meloxicam API for ANJESO?
Suppliers must have active DMFs or equivalent filings, comply with GMP standards, and meet pharmacopeial specifications for purity, residual solvents, and impurities to ensure regulatory acceptability for injectable formulations across global markets.

2. How does supplier reputation impact API quality for ANJESO?
Reputable suppliers with proven regulatory compliance, certification, and quality control systems lower the risk of impurities, contamination, and batch-to-batch variability, critical for sterile injectable products.

3. What factors influence the cost of meloxicam API?
Manufacturing complexity, raw material costs, geographical location, regulatory compliance expenses, and supply chain efficiency influence API pricing. Asian suppliers often offer cost advantages, but Western suppliers may provide higher regulatory clarity.

4. Why is supply chain diversification important for meloxicam API?
Diversification reduces dependency on single sources, minimizes risks related to geopolitical issues, natural disasters, or supply disruptions, and ensures consistent availability for production.

5. What role do quality control standards play in selecting an API supplier?
Strict adherence to pharmacopeial standards, residual solvent limits, impurity profiles, and stability data ensure the API’s safety, efficacy, and suitability for injectable products like ANJESO.

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References:
[1] U.S. Food and Drug Administration (FDA) DMF database.
[2] European Medicines Agency (EMA) public assessment reports.
[3] Pharmaceutical Technology industry reports on API manufacturing.
[4] International Council for Harmonisation (ICH) guidelines.