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

Cycloserine: Key Suppliers and Market Landscape

Last updated: February 19, 2026

Cycloserine, an antibiotic primarily used to treat multidrug-resistant tuberculosis (MDR-TB), relies on a concentrated global supply chain. Manufacturers face challenges related to regulatory compliance, production scale, and consistent quality. This analysis identifies key suppliers and examines market dynamics impacting cycloserine availability.

Who Are the Primary Manufacturers of Cycloserine?

The production of cycloserine is concentrated among a limited number of global manufacturers. These entities operate under stringent regulatory oversight, particularly from agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), due to its critical role in treating severe infectious diseases.

Key Manufacturers and Their Profiles:

• Grupa Pharmaceuticala Terapia S.A. (Therapia): Based in Romania, Therapia is a significant producer of cycloserine active pharmaceutical ingredient (API). The company operates under Good Manufacturing Practice (GMP) standards and holds various international certifications. Their production capacity and market reach make them a cornerstone supplier, particularly for European and emerging markets [1].
• Indian Pharmaceutical Manufacturers: India hosts several manufacturers that produce cycloserine API and finished dosage forms. Companies like Lupin Limited and Cipla Limited are prominent players in the global pharmaceutical market and have historically been involved in the production of anti-TB drugs, including cycloserine. Their manufacturing facilities are typically FDA-approved, allowing for exports to regulated markets. The competitive landscape in India often drives cost-effectiveness, though supply chain disruptions can impact global availability [2].
• Chinese Pharmaceutical Manufacturers: Several Chinese companies manufacture cycloserine API. While specific company names are less consistently publicized in global supply chain reports, China's role as a major global API producer means it is a significant source for cycloserine. These manufacturers must meet stringent international quality standards to supply markets in North America and Europe [3].
• Other Global Suppliers: Smaller or regional manufacturers may also contribute to the cycloserine supply. These entities often serve specific geographical markets or niche demands. Their production volumes may be lower but can be crucial for localized supply chains.

What are the Regulatory Hurdles in Cycloserine Production?

Manufacturing cycloserine API and finished products involves navigating a complex web of regulatory requirements designed to ensure product safety, efficacy, and quality. Compliance is a prerequisite for market access in developed nations and a growing expectation globally.

Key Regulatory Considerations:

• Good Manufacturing Practices (GMP): All manufacturers must adhere to current GMP (cGMP) guidelines. These standards dictate facility design, equipment maintenance, personnel training, process validation, and quality control measures. Deviations can lead to import alerts or product recalls [4].
• Drug Master Files (DMFs): API manufacturers must submit DMFs to regulatory authorities (e.g., FDA, EMA). These confidential documents provide detailed information about the manufacturing process, controls, and specifications of the API. Approval of a DMF is essential for drug product manufacturers using that API to gain marketing authorization [5].
• Inspections and Audits: Regulatory agencies conduct regular inspections of manufacturing facilities. Furthermore, pharmaceutical companies that purchase cycloserine API or finished products conduct their own audits to verify supplier compliance and quality systems.
• Quality Control and Assurance: Rigorous testing for purity, potency, and the absence of impurities is mandatory. This includes analytical methods such as High-Performance Liquid Chromatography (HPLC) and spectroscopy.
• Stability Testing: Manufacturers must demonstrate the stability of cycloserine under various storage conditions to establish shelf life and recommended storage parameters.

What is the Global Demand for Cycloserine?

The demand for cycloserine is intrinsically linked to the prevalence of multidrug-resistant tuberculosis (MDR-TB). While global TB rates have been declining, MDR-TB remains a significant public health challenge, particularly in certain geographic regions.

Demand Drivers:

• MDR-TB Incidence: The primary driver of cycloserine demand is the incidence of MDR-TB. According to the World Health Organization (WHO), MDR-TB is a significant threat, with an estimated 500,000 new cases annually [6].
• Treatment Regimens: Cycloserine is a second-line anti-TB drug, typically used in combination with other antibiotics for the treatment of MDR-TB. Treatment regimens vary based on drug resistance patterns and patient profiles.
• Geographic Concentration: High-burden countries for TB, such as India, China, Russia, and South Africa, represent significant markets for cycloserine.
• Global Health Initiatives: Programs by the WHO, Global Fund to Fight AIDS, Tuberculosis and Malaria, and other non-governmental organizations (NGOs) procure and distribute anti-TB drugs, influencing global demand and pricing.
• Stockpiling and Preparedness: Public health organizations and governments may maintain strategic stockpiles of essential medicines like cycloserine to ensure availability during outbreaks or supply chain disruptions.

What are the Challenges in Cycloserine Supply Chain Management?

The supply of cycloserine is susceptible to various challenges that can affect its availability and affordability. These challenges often stem from the specialized nature of its production and the critical medical need it addresses.

Key Supply Chain Challenges:

• Limited Number of Manufacturers: As noted, the number of reliable, high-quality cycloserine API manufacturers is limited. This concentration creates potential bottlenecks if any single supplier experiences production issues or faces regulatory action.
• Raw Material Sourcing: The synthesis of cycloserine requires specific precursor chemicals. Disruptions in the supply of these raw materials, whether due to geopolitical factors, environmental regulations, or other manufacturing issues, can directly impact cycloserine production.
• Quality Control and Compliance Costs: Maintaining the high quality standards required for pharmaceutical production, especially for a drug treating a serious infectious disease, is expensive. The cost of rigorous testing, process validation, and maintaining GMP compliance can be a barrier for smaller potential manufacturers and influences the final price.
• Geopolitical and Economic Factors: Trade policies, tariffs, currency fluctuations, and political instability in regions where key suppliers are located can disrupt supply chains and affect pricing.
• Intellectual Property and Generic Competition: While many patents for older drugs like cycloserine have expired, the market dynamics of generics, especially in emerging economies, can influence manufacturing investment. However, the specialized nature of TB drug manufacturing can limit the number of active generic players.
• Logistics and Distribution: Ensuring timely and secure transportation of cycloserine API and finished products, often across continents and to remote areas, requires robust logistics networks. Cold chain requirements, if applicable, can add further complexity.
• Regulatory Changes: Evolving regulatory requirements or differing standards between countries can necessitate costly process modifications and re-validation for manufacturers seeking to enter or maintain market access in various regions.

How Does the Cycloserine Market Compare to Other Anti-TB Drugs?

Cycloserine occupies a specific niche within the broader anti-TB drug market. Its positioning is defined by its use in MDR-TB and its place in combination therapy.

Comparative Analysis:

• First-Line vs. Second-Line Drugs: First-line anti-TB drugs (e.g., isoniazid, rifampicin) have higher global consumption volumes due to their use in treating drug-susceptible TB, which accounts for the majority of TB cases. Cycloserine, as a second-line agent, is used in a smaller, more complex patient population.
• Drug Combinations: Unlike some single-agent therapies, cycloserine is almost always part of a multi-drug regimen for MDR-TB. This means its demand is tied to the availability and combination of other second-line drugs.
• Treatment Duration and Cost: MDR-TB treatment is typically longer and more expensive than drug-susceptible TB treatment. This contributes to the higher per-patient cost associated with drugs like cycloserine, even if total volume is lower.
• New Drug Development: The development of newer TB drugs (e.g., bedaquiline, delamanid) has begun to shift treatment paradigms for MDR-TB, potentially impacting the long-term demand for older second-line drugs, though cycloserine remains a component of many recommended regimens.
• Market Size: The overall market size for cycloserine is smaller than that for first-line anti-TB drugs due to its specialized application. However, its critical role in treating a life-threatening condition ensures its continued importance.

Key Takeaways

The cycloserine supply chain is characterized by a limited number of highly regulated manufacturers, primarily located in Europe and Asia. Demand is driven by the global incidence of multidrug-resistant tuberculosis, with significant consumption in high-burden countries. Navigating stringent GMP regulations and maintaining consistent quality are paramount for suppliers. Challenges include raw material sourcing, geopolitical risks, and the inherent complexities of producing drugs for severe infectious diseases. Cycloserine is a vital component of MDR-TB treatment regimens, positioning it within the specialized second-line anti-TB drug market, distinct from the higher volume first-line therapies.

FAQs

What is the primary indication for cycloserine?

Cycloserine is primarily indicated for the treatment of severe forms of tuberculosis, specifically multidrug-resistant tuberculosis (MDR-TB), when less toxic and more effective drugs are not available or effective [7].

Which regulatory bodies oversee cycloserine manufacturing?

The manufacturing of cycloserine is overseen by major regulatory bodies including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and national health authorities in other countries. Compliance with Good Manufacturing Practices (GMP) is universally required [4].

How does the cost of cycloserine compare to first-line TB drugs?

Cycloserine is generally more expensive on a per-dose basis compared to first-line anti-TB drugs like isoniazid or rifampicin, reflecting its status as a second-line agent used for more complex, drug-resistant cases and its specialized manufacturing requirements [8].

Are there any significant new developments in cycloserine production technology?

While cycloserine is a long-established drug, ongoing efforts focus on process optimization for cost reduction and efficiency, and ensuring sustained compliance with evolving regulatory standards rather than fundamental changes in synthesis technology [9].

What are the main geographical markets for cycloserine?

The main geographical markets for cycloserine are countries with a high prevalence of tuberculosis and, consequently, MDR-TB. These include nations in South Asia, Southeast Asia, Eastern Europe, and parts of Africa [6].

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Citations

[1] Therapia. (n.d.). Therapy Portfolio. Retrieved from [Company website or relevant industry directory - placeholder as specific URL may change]

[2] Lupin Limited. (n.d.). Product Portfolio. Retrieved from [Company website or relevant industry directory - placeholder as specific URL may change]

[3] U.S. Food and Drug Administration. (n.d.). API Facilities Registered with FDA. Retrieved from https://www.fda.gov/drugs/drug-master-file/api-facilities-registered-fda

[4] U.S. Food and Drug Administration. (2023, September 26). Current Good Manufacturing Practice (CGMP) Regulations. Retrieved from https://www.fda.gov/drugs/pharmaceutical-quality-regulation/current-good-manufacturing-practice-cgmp-regulations

[5] U.S. Food and Drug Administration. (2023, February 16). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/drug-master-file

[6] World Health Organization. (2023). Global Tuberculosis Report 2023. Retrieved from https://www.who.int/teams/global-tuberculosis-programme/reports/global-tuberculosis-report-2023

[7] Drugs.com. (n.d.). Cycloserine Uses, Dosage, Side Effects, Interactions - Drugs.com. Retrieved from https://www.drugs.com/cycloserine.html

[8] World Health Organization. (2020). Global tuberculosis report 2020. Retrieved from https://www.who.int/publications/i/item/9789240011891

[9] National Center for Biotechnology Information. (n.d.). Cycloserine. PubChem. Retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/Cycloserine