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Thiotepa | CAS No: 52-24-4 | GMP-certified suppliers
A medication that supports conditioning before haematopoietic progenitor cell transplantation and enables high‑dose chemotherapy approaches for haematologic diseases and selected solid tumours in all ages.
Therapeutic categories
Primary indications
- ThioTEPA is used a as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients
- Also, when high dose chemotherapy with HPCT support it is appropriate for the treatment of solid tumours in adult and paediatric patients
Product Snapshot
- Thiotepa is an injectable small‑molecule alkylating agent supplied mainly as lyophilized powder for reconstitution
- It is used for conditioning regimens before allogeneic or autologous HPCT and for high‑dose chemotherapy protocols in select solid tumours
- It is approved in the EU, US, and Canada, with some uses remaining investigational
Clinical Overview
Thiotepa exhibits nonspecific cytotoxic activity through alkylation of nucleophilic sites on DNA. The compound forms covalent bonds at the N7 position of guanine, producing interstrand and intrastrand crosslinks. These lesions prevent DNA strand separation, impede replication, and ultimately induce cell death. The pharmacodynamic effect is not cell cycle specific, consistent with other ethyleneimine alkylators.
After administration, thiotepa distributes extensively into tissues. It undergoes hepatic oxidative desulfuration to its major active metabolite TEPA, mediated primarily by cytochrome P450 enzymes including CYP3A. Both thiotepa and TEPA are eliminated mainly via renal excretion. Thiotepa is also a substrate and inhibitor of CYP enzymes, which may contribute to clinically relevant drug interactions, particularly with agents metabolised by CYP3A. The therapeutic index is narrow, and exposure is influenced by metabolic capacity.
Myelosuppression is the principal dose‑limiting toxicity and a predictable extension of its pharmacologic activity. Additional toxicities may include mucosal irritation, immunosuppression, and organ system effects typical of alkylating agents. Safety considerations emphasize careful monitoring of haematologic parameters and dose adjustments in the context of hepatic impairment due to metabolic dependence.
Thiotepa is used globally in oncology and transplantation settings, with various regional brand formulations available.
For API procurement, suppliers should provide robust control of impurities related to phosphoramide derivatives, validated stability data for this reactive alkylator, and full documentation supporting compliance with pharmacopoeial or regional regulatory standards.
Identification & chemistry
| Generic name | Thiotepa |
|---|---|
| Molecule type | Small molecule |
| CAS | 52-24-4 |
| UNII | 905Z5W3GKH |
| DrugBank ID | DB04572 |
Pharmacology
| Summary | ThioTEPA is an alkylating agent that exerts cytotoxic activity by transferring alkyl groups to DNA, primarily at the N7 position of guanine. This results in DNA crosslinking and structural distortion that prevent strand separation required for replication, leading to loss of proliferative capacity in rapidly dividing cells. Its pharmacologic effects are nonspecific and driven by irreversible DNA damage. |
|---|---|
| Mechanism of action | The alkyl group is attached to the guanine base of DNA, at the number 7 nitrogen atom of the imidazole ring. They stop tumor growth by crosslinking guanine nucleobases in DNA double-helix strands, directly attacking DNA. This makes the strands unable to uncoil and separate. As this is necessary in DNA replication, the cells can no longer divide. These drugs act nonspecifically. |
| Pharmacodynamics | The unstable nitrogen-carbon groups alkylate with DNA causing irrepairable DNA damage. They stop tumor growth by crosslinking guanine nucleobases in DNA double-helix strands, directly attacking DNA. This makes the strands unable to uncoil and separate. As this is necessary in DNA replication, the cells can no longer divide. These drugs act nonspecifically. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA | Humans | cross-linking/alkylation |
ADME / PK
| Half-life | 1.5 to 4.1 hours |
|---|---|
| Route of elimination | Urinary excretion of 14C-labeled thiotepa and metabolites in a 34-year old patient with metastatic carcinoma of the cecum who received a dose of 0.3 mg/kg intravenously was 63%. |
| Clearance | * 446 +/- 63 mL/min [female patients (45 to 84 years) with advanced stage ovarian cancer receiving 60 mg and 80 mg thiotepa by intravenous infusion on subsequent courses given at 4-week intervals] |
Formulation & handling
- Thiotepa is a small, highly water‑soluble molecule formulated primarily as a lyophilized powder for reconstitution for IV, intracavitary, or intravesical administration, supporting aqueous parenteral formulations.
- Solution stability after reconstitution can be limited, so handling typically emphasizes controlled temperature and prompt use to minimize hydrolysis and degradation.
- As an orally available powder exists for non‑parenteral uses, note CYP3A4‑mediated interactions with grapefruit products or St. John’s wort when considering systemic exposure pathways.
Regulatory status
| Lifecycle | Patent expiry has led to a mature, largely generic market for this API across the EU, US, and Canada. Product availability in all three regions indicates a stable late‑lifecycle stage. |
|---|
| Markets | EU, US, Canada |
|---|
Supply Chain
| Supply chain summary | Thiotepa is supplied by multiple packagers, indicating a mature manufacturing base beyond the original developer. Branded products such as Tepadina are established in the US, EU, and Canada, reflecting broad global availability. Patent expiry for thiotepa occurred many years ago, so generic competition is already well‑established in most markets. |
|---|
Thiotepa is a type of Alkylating agents
Alkylating agents are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a significant role in cancer treatment. These compounds possess the ability to attach alkyl groups to the DNA molecule, effectively disrupting its structure and preventing cell replication. This mechanism of action makes alkylating agents potent chemotherapy drugs for various types of cancers.
Alkylating agents are often classified based on their chemical structure, which includes nitrogen mustards, ethylenimines, nitrosoureas, and alkyl sulfonates, among others. Each subclass exhibits unique chemical properties and therapeutic applications. For instance, nitrogen mustards like cyclophosphamide and mechlorethamine are used to treat lymphomas and leukemia, while nitrosoureas such as carmustine and lomustine are effective against brain tumors.
The alkylating agents' mode of action involves the transfer of alkyl groups to cellular components, primarily DNA. This leads to the formation of DNA adducts, cross-links, and DNA strand breaks, ultimately hindering DNA replication and causing cell death. The indiscriminate nature of alkylating agents can also affect healthy cells, leading to various side effects such as bone marrow suppression and gastrointestinal disturbances.
Despite their potential side effects, alkylating agents remain valuable tools in cancer therapy due to their broad spectrum of activity against different types of tumors. Ongoing research focuses on developing more selective and targeted alkylating agents to improve their therapeutic index and minimize adverse effects. The use of alkylating agents in combination with other chemotherapy drugs or radiation therapy is also being explored to enhance treatment outcomes and reduce drug resistance.
In conclusion, alkylating agents are an essential subclass of pharmaceutical APIs widely employed in cancer treatment. Their ability to disrupt DNA structure and impede cell replication makes them effective against various types of tumors, although careful management of side effects is necessary. Ongoing advancements and research continue to refine their therapeutic potential in the fight against cancer.
Thiotepa (Alkylating agents), classified under Anticancer drugs
Anticancer drugs belong to the pharmaceutical API (Active Pharmaceutical Ingredient) category designed specifically to combat cancer cells. These powerful medications play a crucial role in cancer treatment and are developed to target and destroy cancerous cells, preventing their growth and spread.
Anticancer drugs are classified based on their mode of action and can include various types such as chemotherapy drugs, targeted therapy drugs, immunotherapy drugs, and hormonal therapy drugs. Chemotherapy drugs work by interfering with the cell division process, thereby inhibiting the growth of cancer cells. Targeted therapy drugs, on the other hand, are designed to attack specific molecules or genes involved in cancer growth, minimizing damage to healthy cells. Immunotherapy drugs stimulate the body's immune system to recognize and destroy cancer cells. Hormonal therapy drugs are used in cancers that are hormone-dependent, such as breast or prostate cancer, to block the hormones that fuel cancer cell growth.
These APIs are typically synthesized through complex chemical processes in state-of-the-art manufacturing facilities. Stringent quality control measures ensure the purity, potency, and safety of these drugs. Anticancer APIs undergo rigorous testing and adhere to stringent regulatory guidelines before being approved for clinical use.
Due to their critical role in cancer treatment, anticancer drugs are in high demand worldwide. Researchers and pharmaceutical companies continually strive to develop new and more effective APIs in this category to enhance treatment outcomes and minimize side effects. The ongoing advancements in the field of anticancer drug development offer hope for improved cancer therapies and better patient outcomes.
Thiotepa API manufacturers & distributors
Compare qualified Thiotepa API suppliers worldwide. We currently have 9 companies offering Thiotepa API, with manufacturing taking place in 6 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 |
|---|---|---|---|---|---|
| AXXO GmbH | Distributor | Germany | European Union | CoA, EDMF/ASMF, GMP, GDP, MSDS, USDMF | 243 products |
| Emcure Pharma | Producer | India | India | CoA, USDMF | 80 products |
| Heraeus | Producer | Germany | Germany | CoA, GMP, JDMF, USDMF | 10 products |
| ICROM | Producer | Italy | Italy | CoA, GMP | 19 products |
| Indena | Producer | Italy | France | CoA, GMP | 15 products |
| MSN Labs. | Producer | India | India | CoA, GMP, USDMF, WC | 119 products |
| Mylan | Producer | India | India | CoA, GMP, USDMF, WC | 201 products |
| Natco Pharma | Producer | India | India | CoA, USDMF, WC | 40 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 144 products |
When sending a request, specify which Thiotepa 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 Thiotepa 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 Thiotepa API
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Technical
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Regulatory
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