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Capreomycin | CAS No: 11003-38-6 | GMP-certified suppliers
A medication that supports combination treatment of pulmonary tuberculosis, offering reliable antimycobacterial activity for programs requiring second-line therapeutic options in key global markets.
Therapeutic categories
Primary indications
- Used in the treatment of tuberculosis in combination with other drugs
Product Snapshot
- Injectable antibacterial small‑molecule API supplied as a powder for reconstitution for intramuscular or intravenous administration
- It is used as a component of multidrug regimens for tuberculosis
- It is approved in the US and Canada
Clinical Overview
Its pharmacodynamic activity reflects properties shared with aminoglycosides, including bactericidal effects against Mycobacterium tuberculosis. Capreomycin disrupts essential bacterial processes that support survival and replication, contributing to its role in multidrug treatment strategies for tuberculosis.
The precise mechanism of action is not fully defined, but available evidence indicates binding to the 70S bacterial ribosomal complex, leading to impaired protein synthesis. Interaction with additional cellular components appears to induce the formation of abnormal or nonfunctional proteins, which compromises viability of the organism. The drug’s peptide structure and ribosomal interference underpin its classification as a protein synthesis inhibitor.
Absorption is negligible following oral administration, and the drug is administered parenterally. Distribution characteristics are consistent with a peptide antibiotic, and systemic elimination occurs primarily via renal excretion. Capreomycin is identified as having a narrow therapeutic index, and drug accumulation may occur in renal impairment. Pharmacokinetic parameters vary with renal function and dosing interval.
Toxicity concerns include nephrotoxicity and ototoxicity, which are characteristic of aminoglycoside-class agents. Electrolyte disturbances and neuromuscular blockade may occur, particularly in predisposed patients or when administered with other agents affecting neuromuscular transmission. Close monitoring of renal function, auditory symptoms, and serum concentrations is standard practice during therapy.
Capreomycin is available in parenteral formulations used within supervised tuberculosis treatment programs. For API procurement, sourcing should prioritize manufacturers with demonstrated control of peptide antibiotic fermentation and purification processes, robust impurity characterization, and compliance with applicable pharmacopeial and regulatory standards.
Identification & chemistry
| Generic name | Capreomycin |
|---|---|
| Molecule type | Small molecule |
| CAS | 11003-38-6 |
| UNII | 232HYX66HC |
| DrugBank ID | DB00314 |
Pharmacology
| Summary | Capreomycin is an antibacterial agent used with other drugs for tuberculosis and acts by interfering with bacterial protein synthesis. It binds the 70S ribosomal complex and the TlyA‑dependent rRNA methylation pathway, leading to production of nonfunctional proteins. These disruptions impair essential cellular processes and result in bacterial death. |
|---|---|
| Mechanism of action | Little is known about capreomycin's exact mechanism of action, but it is thought to inhibit protein synthesis by binding to the 70S ribosomal unit. Capreomycin also binds to components in the bacterial cell which result in the production of abnormal proteins. These proteins are necessary for the bacteria's survival. Therefore the production of these abnormal proteins is ultimately fatal to the bacteria. |
| Pharmacodynamics | Capreomycin is a member of the aminoglycoside family of antibiotics. These antibiotics have the ability to kill a wide variety of bacteria, including bacteria responsible for causing tuberculosis (TB). |
Targets
| Target | Organism | Actions |
|---|---|---|
| 16S/23S rRNA (cytidine-2'-O)-methyltransferase TlyA | Mycobacterium tuberculosis (strain ATCC 25618 / H37Rv) | inhibitor |
ADME / PK
| Absorption | Not absorbed in significant quantities from the gastrointestinal tract and must be administered parenterally. |
|---|---|
| Route of elimination | When a 1–g dose of capreomycin was given intramuscularly to normal volunteers, 52% was excreted in the urine within 12 hours. |
Formulation & handling
- Capreomycin is an oligopeptide antibiotic requiring parenteral formulation, typically supplied as a lyophilized powder for IM or IV reconstitution.
- High aqueous solubility and peptide structure require careful control of pH and reconstitution conditions to maintain stability and prevent degradation.
- Formulations should consider sensitivity to moisture and support appropriate sterile handling to ensure stability after reconstitution.
Regulatory status
| Lifecycle | Patent‑expiry information was not provided, but based on the product’s presence in both the US and Canadian markets, the API appears to be in a mature phase of its lifecycle. Market dynamics in these regions generally reflect established competition and limited remaining exclusivity unless protected by secondary patents. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Capreomycin is supplied primarily by a single originator‑linked manufacturer, with packaging also handled by additional firms, indicating a relatively concentrated production base. Branded products are marketed in North American regions, including the US and Canada, but there is limited evidence of broader global distribution. Patent expiry for this older antimicrobial suggests that generic competition is already established or readily feasible where regulatory pathways allow. |
|---|
Safety
| Toxicity | Hypokalemia, hypocalcemia, hypomagnesemia, and an electrolyte disturbance resembling Bartter's syndrome have been reported to occur in patients with capreomycin toxicity. The subcutaneous median lethal dose (LD<sub>50</sub>) in mice was 514 mg/kg. |
|---|
- Associated toxicities include disturbances in potassium, calcium, and magnesium balance, with presentations similar to Bartter-like electrolyte abnormalities
- Demonstrates moderate acute toxicity
- Subcutaneous LD50 in mice is approximately 514 mg/kg
US Drug Master File (USDMF)
A US Drug Master File (USDMF) is a confidential document submitted to the U.S. Food and Drug Administration (FDA) that provides detailed information about the manufacturing process of an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical product. This document includes comprehensive details such as chemical properties, manufacturing facilities, production processes, packaging specifications, storage conditions, and more.
The USDMF ensures that proprietary information remains protected while allowing the FDA to review the data as part of drug approval processes. Unlike other types of DMFs used in different regions, the USDMF is specifically designed to meet the regulatory requirements set by the FDA, ensuring compliance with U.S. standards.
Capreomycin is a type of Anti-tuberclosis agents
Anti-tuberculosis agents are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment of tuberculosis (TB), a contagious bacterial infection caused by Mycobacterium tuberculosis. These agents play a crucial role in combating TB by inhibiting the growth and spread of the bacteria.
One of the most commonly used anti-tuberculosis agents is isoniazid, which works by disrupting the synthesis of mycolic acids, essential components of the bacterial cell wall. Another important agent is rifampicin, which inhibits the RNA polymerase enzyme, thus preventing the synthesis of bacterial RNA.
Ethambutol, another widely used agent, disrupts the formation of the bacterial cell wall by inhibiting the arabinosyltransferase enzyme. Pyrazinamide, the fourth main agent, interferes with the metabolism of the bacteria, thereby inhibiting their growth.
Combination therapy involving two or more of these anti-tuberculosis agents is typically employed to achieve the most effective treatment outcomes. This approach helps prevent the development of drug resistance and enhances the bactericidal activity against TB.
The development of anti-tuberculosis agents involves rigorous research, clinical trials, and regulatory approvals. Pharmaceutical companies employ advanced technologies and strict quality control measures to ensure the safety, efficacy, and stability of these APIs.
Overall, the availability of effective anti-tuberculosis agents is crucial in the fight against TB, a global health challenge. Ongoing research and development efforts aim to improve existing agents and develop new ones, with the ultimate goal of eradicating tuberculosis worldwide.
Capreomycin (Anti-tuberclosis agents), classified under Antibacterials
Antibacterials, a category of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in combating bacterial infections. These APIs are chemical compounds that target and inhibit the growth or kill bacteria, helping to eliminate harmful bacterial pathogens from the body.
Antibacterials are essential for the treatment of various bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and more. They are commonly prescribed by healthcare professionals to combat both mild and severe bacterial infections.
Within the category of antibacterials, there are different classes and subclasses of APIs, each with distinct mechanisms of action and target bacteria. Some commonly used antibacterials include penicillins, cephalosporins, tetracyclines, macrolides, and fluoroquinolones. These APIs work by interfering with various aspects of bacterial cellular processes, such as cell wall synthesis, protein synthesis, DNA replication, or enzyme activity.
The development and production of antibacterial APIs require stringent quality control measures to ensure their safety, efficacy, and purity. Pharmaceutical manufacturers must adhere to Good Manufacturing Practices (GMP) and follow rigorous testing protocols to guarantee the quality and consistency of these APIs.
As bacterial resistance to antibiotics continues to be a significant concern, ongoing research and development efforts aim to discover and develop new antibacterial APIs. The evolution of antibacterials plays a crucial role in combating emerging bacterial strains and ensuring effective treatment options for infectious diseases.
In summary, antibacterials are a vital category of pharmaceutical APIs used to treat bacterial infections. They are designed to inhibit or kill bacteria, and their development requires strict adherence to quality control standards. By continually advancing research in this field, scientists and pharmaceutical companies can contribute to the ongoing battle against bacterial infections.
Capreomycin API manufacturers & distributors
Compare qualified Capreomycin API suppliers worldwide. We currently have 1 companies offering Capreomycin API, with manufacturing taking place in 1 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 |
|---|---|---|---|---|---|
| Zhejiang Hisun Pharma | Producer | China | China | CoA, USDMF | 69 products |
When sending a request, specify which Capreomycin 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.).
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Frequently asked questions about Capreomycin API
Sourcing
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Technical
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Regulatory
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