Bulk Pharmaceutical API Sources for cycloserine

Bulk Pharmaceutical API Sources for cycloserine

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		sOt`EPTfVKZjil@
Sigma-Aldrich		C3909_SIGMA
Sigma-Aldrich		C6880_SIGMA
NIH Clinical Collection		SAM001247014
Biosynth		C-9390

Bulk Active Pharmaceutical Ingredient (API) Sources for Cycloserine

Last updated: July 29, 2025

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Introduction

Cycloserine, a second-line anti-tuberculosis agent, is a synthetic antibiotic primarily utilized in multidrug-resistant tuberculosis cases. Its mechanism involves inhibiting bacterial cell wall synthesis by binding to the enzyme alanine racemase, which disrupts mycobacterial growth. As with many pharmaceuticals, the quality, sourcing, and manufacturing of its Active Pharmaceutical Ingredient (API) are critical to therapeutic efficacy and safety. This report dissects the current landscape of bulk API suppliers for Cycloserine, focusing on manufacturing regions, regulatory compliance, and strategic sourcing considerations vital for pharmaceutical developers and procurement professionals.

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Market Overview of Cycloserine API Suppliers

The API manufacturing ecosystem for Cycloserine is relatively niche, concentrated mainly across regions with established chemical synthesis expertise, notably India, China, and Europe. These regions host proprietary or contract manufacturing organizations (CMOs) experienced in producing complex antibiotics and specialized APIs.

The global demand for Cycloserine has been steadily increasing, driven by the rise of drug-resistant tuberculosis (DR-TB) and WHO's emphasis on combination therapies for MDR-TB management. Consequently, API producers are scaling capacities while ensuring compliance with international standards.

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Leading Regions and Manufacturers of Cycloserine API

1. India

India remains a dominant hub for bulk API production, owing to its extensive pharmaceutical industry infrastructure, lower manufacturing costs, and a high volume of generic API production.

• Major Players:

  • Hetero Labs: Known for its synthesis of complex antibiotics, Hetero supplies APIs to various global markets, including Cycloserine, with expertise in GMP-compliant manufacturing.
  • Lupin Limited: Offers a broad portfolio of anti-infectives, including the potential supply of Cycloserine API, emphasizing quality standards compatible with US FDA and EUGMP.
  • Aurobindo Pharma: Engaged in APIs manufacturing, Aurobindo may be a strategic partner for bulk Cycloserine API, leveraging its GMP infrastructure.

• Regulatory Compliance: These manufacturers often hold certifications from the US FDA, EMA, and WHO-GMP, facilitating export to stringent markets.

2. China

China's API sector has grown considerably in recent years, with advances in synthetic chemistry and quality control. Several companies manufacture Cycloserine API for both domestic and international markets.

• Key Suppliers:

  • Shanghai Harvest Biotechnology: Specializes in antibiotic APIs, with capabilities for custom synthesis and bulk production.
  • Shandong Xinhua Pharmaceutical: Engages in the synthesis of various antibiotics, including specialized derivatives, possibly offering Cycloserine.

• Considerations: While Chinese suppliers can offer cost advantages, validating quality assurance protocols and compliance with international standards is necessary before bulk procurement.

3. Europe and North America

Few European or North American companies are known solely for Cycloserine API, given the drug's niche status and synthetic complexity. However, some specialty chemical firms and CMOs in these regions undertake custom synthesis for research and clinical batches, often with strict GMP compliance.

• Implication: These sources are generally suitable for high-purity requirements, preclinical, or clinical trial supplies but may not be the primary bulk suppliers for commercial-scale manufacturing.

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Key Considerations in Sourcing Cycloserine API

Regulatory Compliance and Validation:
Due diligence on manufacturers’ GMP certifications and regulatory inspections is vital. Suppliers with robust quality systems can ensure batch-to-batch consistency and traceability.

Supply Chain Security:
Given the global health importance of TB therapy, securing a reliable, diversified supplier base mitigates risk. Establishing long-term supply agreements and qualifying multiple sources are best practices.

Cost and Lead Time:
While India and China offer competitive pricing, lead times depend on regulatory clearances, manufacturing capacity, and logistical factors. Proximity to end markets can influence distribution efficiency.

Sustainability and Ethical Manufacturing:
Emerging due diligence emphasizes environmental responsibility and ethical labor practices, influencing procurement decisions.

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Emerging Trends and Future Outlook

The drive towards advanced, cost-effective APIs has accelerated the adoption of continuous manufacturing processes and biotechnological innovations. While Cycloserine synthesis remains predominantly chemical, future research may explore biosynthetic pathways or alternative synthesis routes to enhance yield and reduce environmental impact.

Furthermore, with ongoing efforts to combat TB globally, regulatory agencies and funding bodies may incentivize the expansion of API manufacturing capacity for drugs like Cycloserine. Diversification of supplier base and investment in quality assurance infrastructure will be critical as demand increases.

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Conclusion

The sourcing of bulk Cycloserine API remains centered primarily in India and China, with a focus on compliance with international quality standards. While Indian manufacturers currently offer competitive pricing and extensive GMP compliance, Chinese suppliers provide additional capacity and flexibility. Buyers must engage in rigorous supplier qualification procedures, emphasizing regulatory track record, manufacturing capacity, and supply chain stability. As the fight against MDR-TB intensifies, strategic sourcing of high-quality API supplies will be a key factor in ensuring uninterrupted access to effective therapies.

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Key Takeaways

• Regional dominance: India and China are primary sources for Cycloserine API, driven by manufacturing capacity, cost, and technological expertise.
• Quality assurance: Strict evaluation of supplier GMP status and regulatory compliance is essential to meet pharmaceutical standards.
• Supply chain resilience: Diversifying suppliers and establishing long-term partnerships mitigate risks associated with global supply disruptions.
• Cost considerations: Indian suppliers often provide cost advantages; however, validation of quality standards remains paramount.
• Future developments: Technological advances and global health initiatives may expand API production capacity and diversify sourcing options.

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FAQs

1. What are the key factors to consider when sourcing Cycloserine API?
Regulatory compliance, quality standards, manufacturing capacity, supply chain reliability, and cost are critical considerations.

2. Are there any US FDA-approved manufacturers of Cycloserine API?
While some Indian manufacturers hold US FDA approval for APIs, availability of Cycloserine with such certification should be verified through registration databases.

3. How does regional manufacturing impact drug pricing?
Manufacturing in India and China typically reduces costs due to lower labor and material expenses but requires diligent quality monitoring to ensure compliance.

4. Is there a risk of supply shortages in Cycloserine API?
Yes. Dependence on a limited number of suppliers can lead to shortages, emphasizing the importance of supply chain diversification.

5. What are the environmental considerations in Cycloserine manufacturing?
Manufacturing processes should minimize hazardous waste and energy consumption, aligning with sustainability practices to reduce environmental impact.

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Sources:
[1] WHO. (2022). Global Tuberculosis Report.
[2] U.S. Food and Drug Administration. (2023). Drug Master Files and Approved APIs.
[3] Indian Pharmaceutical Alliance. (2022). Annual Industry Report.
[4] Chinese Pharmacopoeia Committee. (2021). Pharmaceutical Standards.
[5] MarketWatch. (2023). API Market Trends & Analysis.