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Cycloserine API Manufacturers & Suppliers
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Cycloserine | CAS No: 68-41-7 | GMP-certified suppliers
A medication that supports combination therapy for tuberculosis and Mycobacterium avium complex infections, offering reliable management options for resistant or complex mycobacterial cases.
Therapeutic categories
Amino AcidsAmino Acids, NeutralAmino Acids, Peptides, and ProteinsAnti-Bacterial AgentsAnti-Infective AgentsAnti-Infective Agents, Urinary
Generic name
Cycloserine
Molecule type
small molecule
CAS number
68-41-7
DrugBank ID
DB00260
Approval status
Approved drug
ATC code
J04AB01
Primary indications
- Used in combination with up to 5 other drugs as a treatment for Mycobacterium avium complex (MAC) and is also used to treat tuberculosis (TB)
Product Snapshot
- Cycloserine is an oral small‑molecule antibacterial supplied mainly as capsule and tablet formulations
- It is used in combination regimens for Mycobacterium avium complex and tuberculosis
- It is approved in the US and Canada
Clinical Overview
Cycloserine (CAS 68-41-7) is an antibiotic produced by Streptomyces garyphalus and is classified within the isoxazoline family, containing a five‑member heterocycle with adjacent oxygen and nitrogen atoms. It is approved for use as part of multidrug regimens for pulmonary and extrapulmonary tuberculosis and is also employed in combination therapy for Mycobacterium avium complex infections. Its role is generally reserved for cases involving resistance or intolerance to first‑line agents.
Cycloserine exhibits concentration‑dependent bactericidal or bacteriostatic activity. It functions as an analog of D‑alanine and disrupts essential steps in bacterial peptidoglycan synthesis. The compound competitively inhibits L‑alanine racemase, which generates D‑alanine, and D‑alanyl‑D‑alanine synthetase, which links D‑alanine residues during cell wall precursor formation. This inhibition weakens bacterial structural integrity and leads to cell death. Activity is directed primarily against Mycobacterium tuberculosis and related organisms.
Absorption after oral administration is generally extensive, and the molecule distributes widely into tissues, including the central nervous system. It is minimally metabolized and is eliminated predominantly unchanged by renal excretion. Renal function strongly influences systemic exposure. Dose adjustments and therapeutic drug monitoring are commonly recommended to mitigate accumulation.
Cycloserine has a narrow therapeutic index. Neurological and psychiatric adverse effects, including headache, tremor, confusion, and, at higher exposures, seizures, are well documented and reflect its classification among neurotoxic agents. Concomitant alcohol use, preexisting psychiatric illness, and renal impairment may increase risk. Hypersensitivity reactions and dermatologic effects have also been reported. Cycloserine is available in some markets under the name Seromycin.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of impurity profiles, validated microbial limits, and consistent stereochemical integrity, as these factors influence safety and regulatory acceptance. Robust documentation supporting GMP compliance and stability data is essential for formulation and regulatory activities.
Cycloserine exhibits concentration‑dependent bactericidal or bacteriostatic activity. It functions as an analog of D‑alanine and disrupts essential steps in bacterial peptidoglycan synthesis. The compound competitively inhibits L‑alanine racemase, which generates D‑alanine, and D‑alanyl‑D‑alanine synthetase, which links D‑alanine residues during cell wall precursor formation. This inhibition weakens bacterial structural integrity and leads to cell death. Activity is directed primarily against Mycobacterium tuberculosis and related organisms.
Absorption after oral administration is generally extensive, and the molecule distributes widely into tissues, including the central nervous system. It is minimally metabolized and is eliminated predominantly unchanged by renal excretion. Renal function strongly influences systemic exposure. Dose adjustments and therapeutic drug monitoring are commonly recommended to mitigate accumulation.
Cycloserine has a narrow therapeutic index. Neurological and psychiatric adverse effects, including headache, tremor, confusion, and, at higher exposures, seizures, are well documented and reflect its classification among neurotoxic agents. Concomitant alcohol use, preexisting psychiatric illness, and renal impairment may increase risk. Hypersensitivity reactions and dermatologic effects have also been reported. Cycloserine is available in some markets under the name Seromycin.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of impurity profiles, validated microbial limits, and consistent stereochemical integrity, as these factors influence safety and regulatory acceptance. Robust documentation supporting GMP compliance and stability data is essential for formulation and regulatory activities.
Identification & chemistry
| Generic name | Cycloserine |
|---|---|
| Molecule type | Small molecule |
| CAS | 68-41-7 |
| UNII | 95IK5KI84Z |
| DrugBank ID | DB00260 |
Pharmacology
| Summary | Cycloserine is an analog of D‑alanine that disrupts early cytoplasmic steps of bacterial cell wall synthesis by competitively inhibiting alanine racemase and D‑alanine–D‑alanine ligase. This blockade prevents formation of peptidoglycan precursors, weakening the bacterial cell wall. Its activity can be bactericidal or bacteriostatic depending on organism susceptibility and local drug concentration. |
|---|---|
| Mechanism of action | Cycloserine is an analog of the amino acid D-alanine. It interferes with an early step in bacterial cell wall synthesis in the cytoplasm by competitive inhibition of two enzymes, L-alanine racemase, which forms D-alanine from L-alanine, and D-alanylalanine synthetase, which incorporates D-alanine into the pentapeptide necessary for peptidoglycan formation and bacterial cell wall synthesis. |
| Pharmacodynamics | Cycloserine, a broad-spectrum antibiotic, may be bactericidal or bacteriostatic, depending on its concentration at the site of infection and the susceptibility of the organism. Cycloserine works by blocking the formation of these peptidoglycans. By doing this the walls of the bacteria become weak and it results in the death of the bacteria |
Targets
| Target | Organism | Actions |
|---|---|---|
| D-alanine--D-alanine ligase A | Escherichia coli (strain K12) | inhibitor |
| Alanine racemase | Mycobacterium avium | inhibitor |
ADME / PK
| Absorption | Rapidly and almost completely absorbed (70 to 90%) from the gastrointestinal tract following oral administration. |
|---|---|
| Half-life | Half-life in patients with normal renal function is 10 hours, and is prolonged in patients with impaired renal function. |
Formulation & handling
- Oral small‑molecule API with high aqueous solubility, enabling simple solid‑oral formulations such as capsules or tablets.
- Absorption rate can be reduced by high‑fat meals, so formulations may consider labeling or timing to mitigate variable uptake.
- Hydrophilic, low‑LogP profile suggests minimal need for solubilization technologies and supports straightforward handling as a stable solid.
Regulatory status
| Lifecycle | Patent‑expiry–driven lifecycle maturity will depend on the specific API’s remaining exclusivities, but in markets such as the US and Canada, products generally shift toward a mature, competitive phase once key patents or data protections lapse. Across these markets, the API’s lifecycle is therefore shaped primarily by the timing of generic entry and the extent of established market availability. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The supply landscape for cycloserine is centered on a single originator‑associated manufacturer, with several affiliated packagers handling branded and legacy presentations. Commercial products are established mainly in the US and Canada, indicating a limited but stable global footprint. Patent expiry occurred long ago for this older antimicrobial, so generic competition is established or readily supportable where regulatory pathways allow. |
|---|
Safety
| Toxicity | Oral LD<sub>50</sub> in mouse is 5290 mg/kg, and in rat is over 5000 mg/kg. Symptoms of a cycloserine overdose include drowsiness, confusion, headache, dizziness, irritability, numbness and tingling, difficulty speaking, paralysis, abnormal behavior, seizures, and unconsciousness. |
|---|
High Level Warnings:
- High oral LD50 values in rodents (mouse 5290 mg/kg
- Rat ›5000 mg/kg) indicate low acute lethality, but neurotoxic effects can emerge at elevated exposures
- Overdose is associated with central nervous system disturbances, including altered behavior, neuromotor impairment, and seizure risk
Cycloserine is a type of Antituberculars
Antituberculars are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment of tuberculosis (TB). TB is a highly contagious infectious disease caused by the bacteria Mycobacterium tuberculosis, primarily affecting the lungs but also capable of affecting other organs. Antitubercular APIs play a crucial role in eradicating and controlling this global health concern.
These APIs exhibit powerful antimicrobial properties specifically targeting Mycobacterium tuberculosis. They act by inhibiting the growth and replication of the bacteria, preventing the spread of the infection. Antitubercular APIs are often used in combination therapies to maximize efficacy and minimize the development of drug resistance.
Common antitubercular APIs include isoniazid, rifampicin, pyrazinamide, ethambutol, and streptomycin. These APIs are typically administered orally or through injectable formulations, allowing for effective delivery and distribution throughout the body.
The development and production of antitubercular APIs require stringent quality control measures to ensure safety and efficacy. Pharmaceutical companies adhere to Good Manufacturing Practices (GMP) guidelines and rigorous regulatory standards to guarantee the production of high-quality APIs.
In conclusion, antitubercular APIs play a critical role in the treatment and control of tuberculosis. By effectively targeting and inhibiting the growth of Mycobacterium tuberculosis, these APIs contribute to reducing the burden of this infectious disease worldwide. Their development and production follow strict quality control standards to ensure safe and efficacious treatment options for patients.
Cycloserine API manufacturers & distributors
Compare qualified Cycloserine API suppliers worldwide. We currently have 3 companies offering Cycloserine API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| AMARI TRADE ALLIANEC LLP | Distributor | India | India | CoA | 15 products |
| Sichuan Benepure | Producer | China | China | CoA | 23 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001 | 757 products |
When sending a request, specify which Cycloserine API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Cycloserine API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Cycloserine API
Sourcing
What matters most when sourcing GMP-grade Cycloserine?
Key considerations include confirming GMP compliance from the originator‑associated manufacturer and ensuring traceability through affiliated packagers. Because the global footprint is limited, verifying consistent supply availability is important. Alignment with US and Canadian regulatory requirements is essential for qualification. Generic competition is established, so assessing equivalence and regulatory supportability may also be relevant.
Which documents are typically required when sourcing Cycloserine API?
Request the core API documentation set: CoA (2 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Cycloserine API?
Known or reported manufacturers for Cycloserine: AMARI TRADE ALLIANEC LLP. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Cycloserine API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Cycloserine manufacturers?
Audit reports may be requested for Cycloserine: 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Cycloserine API on Pharmaoffer?
Reported supplier count for Cycloserine: 2 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Cycloserine API?
Production countries reported for Cycloserine: India (1 producer), China (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Cycloserine usually hold?
Common certifications for Cycloserine suppliers: CoA (2 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Cycloserine (CAS 68-41-7) used for?
Cycloserine is used as a second‑line antibiotic in multidrug regimens for pulmonary and extrapulmonary tuberculosis, particularly when resistance or intolerance to first‑line agents is present. It is also employed in combination therapy for infections caused by Mycobacterium avium complex.
Which therapeutic class does Cycloserine fall into?
Cycloserine belongs to the following therapeutic categories: Amino Acids, Amino Acids, Neutral, Amino Acids, Peptides, and Proteins, Anti-Bacterial Agents, Anti-Infective Agents. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Cycloserine mainly prescribed for?
The primary indications for Cycloserine: Used in combination with up to 5 other drugs as a treatment for Mycobacterium avium complex (MAC) and is also used to treat tuberculosis (TB). These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Cycloserine work?
Cycloserine is an analog of the amino acid D-alanine. It interferes with an early step in bacterial cell wall synthesis in the cytoplasm by competitive inhibition of two enzymes, L-alanine racemase, which forms D-alanine from L-alanine, and D-alanylalanine synthetase, which incorporates D-alanine into the pentapeptide necessary for peptidoglycan formation and bacterial cell wall synthesis.
What should someone know about the safety or toxicity profile of Cycloserine?
Cycloserine has a narrow therapeutic index, and its primary safety concerns relate to dose‑dependent neurotoxicity. Even though acute lethality in animal studies is low, elevated exposures can cause central nervous system effects such as behavioral changes, neuromotor impairment, and seizures. Risk increases with factors that raise systemic levels, including renal impairment or concomitant alcohol use. Hypersensitivity and dermatologic reactions have also been reported.
What are important formulation and handling considerations for Cycloserine as an API?
Cycloserine’s high aqueous solubility and hydrophilic, low‑LogP profile allow straightforward capsule or tablet formulations without specialized solubilization approaches. Absorption can be reduced by high‑fat meals, so instructions on administration timing may be needed to limit variability. As a stable solid oral API, it generally supports standard handling and manufacturing practices. Renal elimination and a prolonged half‑life in renal impairment may inform dosing‑related considerations but do not affect formulation.
Is Cycloserine a small molecule?
Cycloserine is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Cycloserine?
Based on its hydrophilic, low‑LogP profile and behavior as a stable solid, no special stability concerns beyond standard solid‑oral handling are indicated. Its high aqueous solubility supports conventional capsule or tablet formulations without additional stabilization measures. Routine storage and protection appropriate for solid oral APIs are generally sufficient.
Regulatory
Where is Cycloserine approved or in use globally?
Cycloserine is reported as approved in the following major regions: US, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Cycloserine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Cycloserine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Cycloserine included in the PRO Data Insights coverage?
PRO Data Insights coverage for Cycloserine: 442 verified transactions across 128 suppliers and 67 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Cycloserine?
Market report availability for Cycloserine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
