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Carmustine API from France Manufacturers & Suppliers
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Employees: 5000+
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ISO9001|
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CoA
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CoAAll certificates
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China|
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CoA
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Audit Report:
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CEP|
USDMF|
WC|
CoAAll certificates
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WC
CoA
Producer
Produced in
India|
Audit Report:
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GMP
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FDA|
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Carmustine | CAS No: 154-93-8 | GMP-certified suppliers
A medication that supports treatment of brain tumors, multiple myeloma, Hodgkin’s disease, and non‑Hodgkin lymphomas for oncology‑focused API sourcing needs.
Therapeutic categories
Alkylating ActivityAlkylating DrugsAmidesAntineoplastic AgentsAntineoplastic Agents, AlkylatingAntineoplastic and Immunomodulating Agents
Generic name
Carmustine
Molecule type
small molecule
CAS number
154-93-8
DrugBank ID
DB00262
Approval status
Approved drug, Investigational drug
ATC code
L01AD01
Primary indications
- For the treatment of brain tumors, multiple myeloma, Hodgkin's disease and Non-Hodgkin's lymphomas
Product Snapshot
- Small‑molecule alkylating agent supplied mainly as injectable powders/solutions and as intracranial implant wafers
- Used for brain tumors, multiple myeloma, Hodgkin’s disease, and non‑Hodgkin’s lymphomas
- Approved in the US, Canada, and EU, with some presentations remaining investigational
Clinical Overview
Carmustine (CAS 154-93-8) is a nitrosourea alkylating agent used in the management of primary and metastatic brain tumors, multiple myeloma, Hodgkin disease, and non‑Hodgkin lymphomas. It is considered cell‑cycle nonspecific and is commonly applied in palliative or combination regimens where deep central nervous system penetration is required.
Its pharmacology is defined by dual reactivity: alkylation of nucleic acids and carbamoylation of proteins. Carmustine forms interstrand and intrastrand DNA and RNA cross‑links that impair DNA replication, RNA transcription, and translation. It also carbamoylates amino acid residues in enzymes such as glutathione reductase, disrupting cellular redox balance and contributing to cytotoxicity. Lack of complete cross‑resistance with other alkylators supports its use in specific combination protocols.
Carmustine is highly lipophilic and readily crosses the blood–brain barrier, a property central to its role in neuro‑oncology. After intravenous administration, it undergoes rapid, extensive non‑enzymatic and enzymatic degradation to active and inactive metabolites. Systemic exposure is brief due to a short plasma half‑life. Elimination occurs predominantly via renal pathways as metabolites, with minor pulmonary excretion. Protein binding and tissue distribution are substantial, though values vary by formulation and patient status.
Toxicity is characterized mainly by delayed myelosuppression, often reaching nadir several weeks after dosing. Pulmonary toxicity, including interstitial pneumonitis and fibrosis, is a recognized risk, particularly with cumulative exposure. Hepatic and renal functional impairment, gastrointestinal effects, and infusion‑related reactions may occur. Carmustine is considered a potential human carcinogen and is classified as a narrow therapeutic index drug, requiring careful dose adjustment and monitoring.
Carmustine is available in several contexts, including parenteral formulations such as BiCNU and implantable wafers such as Gliadel for localized intracranial delivery.
For API procurement, attention should focus on validated control of nitrosourea stability, impurity profiling, containment for potent cytotoxics, and documentation aligned with global regulatory expectations for oncology APIs.
Its pharmacology is defined by dual reactivity: alkylation of nucleic acids and carbamoylation of proteins. Carmustine forms interstrand and intrastrand DNA and RNA cross‑links that impair DNA replication, RNA transcription, and translation. It also carbamoylates amino acid residues in enzymes such as glutathione reductase, disrupting cellular redox balance and contributing to cytotoxicity. Lack of complete cross‑resistance with other alkylators supports its use in specific combination protocols.
Carmustine is highly lipophilic and readily crosses the blood–brain barrier, a property central to its role in neuro‑oncology. After intravenous administration, it undergoes rapid, extensive non‑enzymatic and enzymatic degradation to active and inactive metabolites. Systemic exposure is brief due to a short plasma half‑life. Elimination occurs predominantly via renal pathways as metabolites, with minor pulmonary excretion. Protein binding and tissue distribution are substantial, though values vary by formulation and patient status.
Toxicity is characterized mainly by delayed myelosuppression, often reaching nadir several weeks after dosing. Pulmonary toxicity, including interstitial pneumonitis and fibrosis, is a recognized risk, particularly with cumulative exposure. Hepatic and renal functional impairment, gastrointestinal effects, and infusion‑related reactions may occur. Carmustine is considered a potential human carcinogen and is classified as a narrow therapeutic index drug, requiring careful dose adjustment and monitoring.
Carmustine is available in several contexts, including parenteral formulations such as BiCNU and implantable wafers such as Gliadel for localized intracranial delivery.
For API procurement, attention should focus on validated control of nitrosourea stability, impurity profiling, containment for potent cytotoxics, and documentation aligned with global regulatory expectations for oncology APIs.
Identification & chemistry
| Generic name | Carmustine |
|---|---|
| Molecule type | Small molecule |
| CAS | 154-93-8 |
| UNII | U68WG3173Y |
| DrugBank ID | DB00262 |
Pharmacology
| Summary | Carmustine is a nitrosourea alkylating agent that forms cross-links in DNA and RNA, disrupting nucleic acid synthesis and protein translation. It also carbamoylates cellular proteins, including glutathione reductase, contributing to broad inhibition of metabolic and enzymatic processes. These combined actions promote cytotoxicity in tumors such as brain malignancies, multiple myeloma, Hodgkin’s disease, and non‑Hodgkin’s lymphomas. |
|---|---|
| Mechanism of action | Carmustine causes cross-links in DNA and RNA, leading to the inhibition of DNA synthesis, RNA production and RNA translation (protein synthesis). Carmustine also binds to and modifies (carbamoylates) glutathione reductase. This leads to cell death. |
| Pharmacodynamics | Carmustine is one of the nitrosoureas indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in treatment of brain tumors, multiple myeloma, Hodgkin's disease, and non-Hodgkin's lymphomas. Although it is generally agreed that carmustine alkylates DNA and RNA, it is not cross resistant with other alkylators. As with other nitrosoureas, it may also inhibit several key enzymatic processes by carbamoylation of amino acids in proteins. |
Targets
| Target | Organism | Actions |
|---|---|---|
| RNA | Humans | other/unknown |
| Glutathione reductase, mitochondrial | Humans | inhibitor |
| DNA | Humans | other/unknown |
ADME / PK
| Absorption | 5 to 28% bioavailability |
|---|---|
| Half-life | 15-30 minutes |
| Protein binding | 80% |
| Metabolism | Hepatic and rapid with active metabolites. Metabolites may persist in the plasma for several days. |
| Route of elimination | Approximately 60% to 70% of a total dose is excreted in the urine in 96 hours and about 10% as respiratory CO2. |
Formulation & handling
- Carmustine is a small‑molecule nitrosourea formulated mainly as lyophilized powder for reconstitution for IV or parenteral use due to its limited aqueous stability.
- The API is chemically unstable in aqueous solution and requires prompt use after reconstitution, with protection from light and controlled‑temperature handling.
- Wafers and implants rely on polymer‑based matrices for localized, controlled release at intracavitary or intralesional sites.
Regulatory status
| Lifecycle | Patent protection in the US, Canada, and the EU has expired or is approaching expiry, indicating that the API is transitioning into a mature phase of its lifecycle. These markets typically support established generic competition, reflecting a stable and competitive environment. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Carmustine is supplied by a small set of originator firms with manufacturing and packaging distributed across the United States and other regulated markets. Branded products such as BiCNU have long-standing presence in the US, Canada, and the EU. Original patents have expired, supporting established generic competition in multiple regions. |
|---|
Safety
| Toxicity | The oral LD<sub>50</sub>s in rat and mouse are 20 mg/kg and 45 mg/kg, respectively. Side effects include leukopenia, thrombocytopenia, nausea. Toxic effects include pulmonary fibrosis (20-0%) and bone marrow toxicity. |
|---|
High Level Warnings:
- Low acute oral LD50 in rodents (rat ~20 mg/kg, mouse ~45 mg/kg) indicates high systemic toxicity
- Implement stringent exposure controls for powder handling
- Associated with hematologic toxicity including leukopenia, thrombocytopenia, and broader bone‑marrow suppression
Carmustine is a type of Antineoplastics
Antineoplastics are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) primarily used in the treatment of cancer. These powerful substances inhibit or destroy the growth of cancer cells, thus impeding the progression of malignancies.
Antineoplastics exert their therapeutic effects through various mechanisms. Some APIs interfere with DNA replication, inhibiting the division and proliferation of cancer cells. Others target specific proteins or enzymes involved in tumor growth, effectively blocking their function. Additionally, certain antineoplastic agents induce programmed cell death, known as apoptosis, in cancer cells.
These APIs find application in a wide range of cancer treatments, including chemotherapy, targeted therapy, immunotherapy, and hormone therapy. They are often administered in combination with other drugs to optimize therapeutic outcomes and minimize drug resistance.
Antineoplastics are typically synthesized through complex chemical processes, ensuring high purity and potency. Stringent quality control measures are implemented throughout manufacturing to meet regulatory standards and ensure patient safety.
Although antineoplastics offer significant benefits in treating cancer, they can also cause adverse effects due to their cytotoxic nature. Common side effects include bone marrow suppression, gastrointestinal disturbances, hair loss, and immune system suppression. Close monitoring and supportive care are essential to manage these side effects effectively.
In conclusion, antineoplastics are a vital category of pharmaceutical APIs used in the treatment of cancer. Through their diverse mechanisms of action, these compounds play a critical role in combating malignancies and improving patient outcomes.
Carmustine API manufacturers & distributors
Compare qualified Carmustine API suppliers worldwide. We currently have 8 companies offering Carmustine API, with manufacturing taking place in 5 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 |
|---|---|---|---|---|---|
| Ampac Fine Chemicals | Producer | United States | United States | CEP, CoA, FDA, GMP | 6 products |
| ChemPacific | Producer | United States | Unknown | CoA, USDMF, WC | 10 products |
| Emcure Pharma | Producer | India | India | CEP, CoA, FDA, GMP, USDMF | 80 products |
| Indena | Producer | Italy | France | CoA, GMP | 15 products |
| Kromozome | Distributor | India | India | CoA, GMP | 17 products |
| MSN Labs. | Producer | India | India | CEP, CoA, GMP, USDMF, WC | 119 products |
| Shilpa Medicare Ltd | Producer | India | India | CoA, FDA, GMP, ISO9001 | 54 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, MSDS, USDMF | 764 products |
When sending a request, specify which Carmustine 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 Carmustine 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 Carmustine API
Sourcing
What matters most when sourcing GMP-grade Carmustine?
When sourcing GMP‑grade Carmustine, it is essential to work with manufacturers that operate within the regulatory frameworks of the United States, Canada, or the EU. Given that supply comes from a small group of originator firms with production in these regulated markets, confirming their compliance and established history is key. The long‑standing presence of products like BiCNU and the availability of generics also make it important to verify the specific source within this established supply base.
Which documents are typically required when sourcing Carmustine API?
Request the core API documentation set: CoA (8 companies), GMP (7 companies), USDMF (4 companies), CEP (3 companies), FDA (3 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Carmustine API?
Known or reported manufacturers for Carmustine: Sinoway industrial Co.,Ltd, Shilpa Medicare Ltd, Kromozome. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Carmustine 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 Carmustine manufacturers?
Audit reports may be requested for Carmustine: 2 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Carmustine API on Pharmaoffer?
Reported supplier count for Carmustine: 8 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Carmustine API?
Production countries reported for Carmustine: India (4 producers), China (1 producer), France (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Carmustine usually hold?
Common certifications for Carmustine suppliers: CoA (8 companies), GMP (7 companies), USDMF (4 companies), CEP (3 companies), FDA (3 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Carmustine (CAS 154-93-8) used for?
Carmustine is used as a nitrosourea alkylating agent for treating primary and metastatic brain tumors, multiple myeloma, Hodgkin disease, and non‑Hodgkin lymphomas. Its role is supported by its ability to cross the blood–brain barrier and its activity in palliative or combination regimens.
Which therapeutic class does Carmustine fall into?
Carmustine belongs to the following therapeutic categories: Alkylating Activity, Alkylating Drugs, Amides, Antineoplastic Agents, Antineoplastic Agents, Alkylating. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Carmustine mainly prescribed for?
The primary indications for Carmustine: For the treatment of brain tumors, multiple myeloma, Hodgkin's disease and Non-Hodgkin's lymphomas. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Carmustine work?
Carmustine causes cross-links in DNA and RNA, leading to the inhibition of DNA synthesis, RNA production and RNA translation (protein synthesis). Carmustine also binds to and modifies (carbamoylates) glutathione reductase. This leads to cell death.
What should someone know about the safety or toxicity profile of Carmustine?
Carmustine has a high intrinsic toxicity, reflected by low acute oral LD50 values in rodents, and requires strict containment when handling the API powder. Its major clinical risks include delayed bone‑marrow suppression, pulmonary toxicity with cumulative exposure, and potential hepatic, renal, and gastrointestinal effects. It is considered a potential human carcinogen and a narrow‑therapeutic‑index agent, necessitating careful dose control and monitoring. Infusion reactions can occur, and both systemic and localized formulations carry risks consistent with its cytotoxic mechanism.
What are important formulation and handling considerations for Carmustine as an API?
Carmustine is typically supplied as a lyophilized powder because the API is chemically unstable in aqueous solution and must be used promptly after reconstitution. Solutions require protection from light and controlled‑temperature handling to limit degradation. For localized administration, polymer‑based wafers or implants are used to provide controlled release at the target site.
Is Carmustine a small molecule?
Carmustine is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Carmustine?
Carmustine is chemically unstable in aqueous environments, which is why it is typically supplied as a lyophilized powder for reconstitution immediately before use. Because of this limited aqueous stability, an oral dosage form would face degradation risks when exposed to gastrointestinal fluids. The API is also light‑sensitive and requires controlled‑temperature handling, factors that would further complicate oral formulation.
Regulatory
Where is Carmustine approved or in use globally?
Carmustine is reported as approved in the following major regions: US, Canada, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Carmustine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Carmustine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Carmustine included in the PRO Data Insights coverage?
PRO Data Insights coverage for Carmustine: 133 verified transactions across 47 suppliers and 33 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Carmustine?
Market report availability for Carmustine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
