Suppliers and packagers for generic pharmaceutical drug: cycloserine

cycloserine

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sanaluz	SEROMYCIN	cycloserine	CAPSULE;ORAL	060593	ANDA	Dr. Reddy?s Laboratories, Inc.	43598-235-31	3 BLISTER PACK in 1 CARTON (43598-235-31) / 10 CAPSULE in 1 BLISTER PACK (43598-235-10)	2023-03-15

Suppliers for the Pharmaceutical Drug: Cycloserine

Last updated: July 28, 2025

Introduction

Cycloserine, also known as D-cycloserine, is an antibiotic primarily used in the treatment of multidrug-resistant tuberculosis (MDR-TB) and sometimes explored for neuropsychiatric conditions. As a critical component in combating resistant strains of Mycobacterium tuberculosis, the timely supply and reliable sourcing of cycloserine remain vital for global health initiatives. This article examines the current landscape of suppliers providing cycloserine, focusing on manufacturing capabilities, regulatory considerations, and market dynamics shaping its availability.

Manufacturers and Supply Chain Overview

Existing Major Suppliers

Historically, the production of cycloserine has been concentrated among a handful of pharmaceutical and chemical manufacturing entities, predominantly located in China, India, and European countries. These regions host laboratories with dedicated capacities for synthesizing amino acid derivatives and specialty antibiotics.

• Hunan Huishou Pharmaceutical Co., Ltd. (China): A prominent manufacturer specializing in a variety of antibiotics, including cycloserine, with WHO prequalification status for certain drugs. Their facilities adhere to strict cGMP standards, ensuring global export compliance.

• Jiangxi Jianyuan Pharmaceutical Co., Ltd. (China): Known for producing active pharmaceutical ingredients (APIs), including cycloserine, targeting both domestic and international markets. Their production capacity aligns with the supply demands of global tuberculosis programs.

• Dr. Reddy’s Laboratories (India): A major pharmaceutical company with a robust API manufacturing division. Although primarily known for generics, their capacity to produce cycloserine contributes to the global supply chain, particularly for South Asian markets.

• Sandoz (Novartis division) (Switzerland): Engages in producing high-quality APIs, including specialty antibiotics. Their global network facilitates distribution to markets with stringent regulatory standards.

Emerging and Contingent Suppliers

In response to production shortages or the increasing demand driven by MDR-TB treatment programs, newer manufacturers have emerged:

• Cipla Limited (India): With extensive experience in antibiotics, Cipla has invested in the capacity to synthesize cycloserine, aiming to diversify the supply base.

• Zhejiang Huahai Pharmaceuticals (China): Known for manufacturing generic APIs, including amino acid derivatives, potentially including cycloserine as per market demands.

Regulatory and Certification Considerations

Suppliers with certifications such as WHO prequalification, European Medicines Agency (EMA) approval, or U.S. Food and Drug Administration (FDA) approval are more likely to be favored for global procurement, especially for programs under UNICEF, GAVI, or the Global Fund.

• WHO Prequalification: Signifies adherence to international quality standards, facilitating procurement for UN agencies and NGOs.

• EMA and FDA Approvals: Play a significant role in ensuring compliance in developed markets, with implications for export and global distribution.

Production Challenges and Supply Risks

The synthesis of cycloserine involves complex processes due to its stereochemistry and the need for high purity. Challenges include:

• Raw Material Availability: Dependence on high-quality starting materials such as D-serine or D-serine derivatives.

• Manufacturing Complexity: Maintaining stereochemical purity to prevent contamination or efficacy reduction.

• Regulatory Stringency: Navigating varying regional approvals and documentation requirements.

These factors can lead to production bottlenecks, supply shortages, and price fluctuations.

Market Dynamics and Strategic Sourcing

The global demand for cycloserine is driven largely by public health programs targeting MDR-TB. Consequently, procurement agencies prioritize reliable, quality-assured sources, often through pooled purchasing mechanisms like the Global Drug Facility (GDF).

Recent trends indicate an increasing push toward:

• Diversification of Suppliers: To mitigate risks associated with supply chain disruptions.

• Local Manufacturing Initiatives: Encouraging regional production capabilities to enhance supply security.

• Regulatory Harmonization: Accelerating approval pathways to facilitate rapid market entry for new manufacturers.

Emerging Trends and Future Outlook

Advancements in synthetic methodologies, such as continuous-flow chemistry, could streamline production and improve yields. Furthermore, biotechnological approaches are under exploration to produce amino acid derivatives more sustainably and efficiently.

Policy efforts aimed at strengthening the global supply chain include:

• Establishing strategic stockpiles.

• Promoting technology transfer to emerging producers.

• Enhancing quality assurance frameworks.

The increased collaboration between governmental, non-governmental, and private sector stakeholders will be pivotal in ensuring consistent, affordable access to cycloserine.

Conclusion

The supply landscape for cycloserine encompasses a limited but strategic network of manufacturers capable of meeting global health needs. Ensuring sustained, high-quality production involves navigating technical manufacturing challenges, regulatory compliance, and geopolitical factors. Diversification of suppliers, robust quality standards, and technological innovations are critical to securing an uninterrupted supply of this vital drug in the fight against MDR-TB.

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Key Takeaways

• Limited but Concentrated Supply Base: Major producers primarily operate in China, India, and Europe, emphasizing the need for diversification.

• Regulatory Certification: WHO prequalification and EMA/FDA approval are vital markers of supplier credibility and access to global markets.

• Manufacturing Challenges: The stereochemical complexity of cycloserine introduces production risks and supply vulnerabilities.

• Market Dynamics: Public health programs and international procurement agencies influence demand and supply stability.

• Future Directions: Innovation in synthetic methods and regional manufacturing initiatives will be essential for enhancing supply security.

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FAQs

1. Who are the leading suppliers of cycloserine globally?
   Key producers include Hunan Huishou Pharmaceutical, Jiangxi Jianyuan Pharmaceutical (China), Dr. Reddy’s Laboratories (India), and Sandoz (Switzerland). These companies hold significant manufacturing capacity and, in some cases, international quality certifications.

2. What regulations impact the sourcing of cycloserine?
   Suppliers with WHO prequalification, EMA, or FDA approval are preferred for international procurement, especially for programs supporting global TB control efforts. These certifications confirm compliance with quality standards essential for safe and effective medicine distribution.

3. Are there emerging manufacturers in the cycloserine market?
   Yes, companies like Cipla and Zhejiang Huahai Pharmaceuticals are expanding their capacity and diversifying the supply base, driven by increasing demand and strategic market considerations.

4. What are the major challenges in the manufacturing of cycloserine?
   The synthesis process’s complexity, raw material sourcing, and strict regulatory standards pose challenges. These factors can lead to production delays, shortages, and variability in supply.

5. How is the future of cycloserine supply expected to evolve?
   Innovations in manufacturing, policy initiatives promoting regional production, and strengthening supply chain resilience are anticipated to improve availability. Strategic collaborations and technological advancements will further ensure steady supply streams to meet global health needs.

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Sources:
[1] World Health Organization, "Prequalification of Medicines Programme," 2022.
[2] Global Drug Facility, "Annual Procurement Report," 2023.
[3] Market research reports on antibiotic manufacturing, 2022.
[4] Company websites and official certifications.