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Producer
Produced in
India|
Employees: 200+
|
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Certifications:
GMP
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USDMF|
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Employees: 25
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Produced in
China|
Employees: 50+
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USDMF
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MSDS|
ISO9001|
CoA|
WCAll certificates
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ISO9001
CoA
WC
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Produced in
United States|
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CoAAll certificates
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CoA
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Produced in
Slovenia|
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GMP
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CoAAll certificates
GMP
CoA
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Produced in
Spain|
Employees: 3,500+
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CEP|
USDMF|
MSDS|
CoAAll certificates
GMP
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CoA
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WC
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CoA
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coaAll certificates
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Netherlands|
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CoA
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Produced in
Italy|
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ISO9001|
CoAAll certificates
GMP
USDMF
ISO9001
CoA
Producer
Produced in
India|
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GMP
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WC|
CoAAll certificates
GMP
WC
CoA
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Exemestane | CAS No: 107868-30-4 | GMP-certified suppliers
A medication that supports treatment of advanced breast cancer in postmenopausal women whose disease has progressed after tamoxifen therapy, serving established North American markets.
Therapeutic categories
AndrostanesAndrostenesAntineoplastic AgentsAntineoplastic and Immunomodulating AgentsAromatase InhibitorsCytochrome P-450 CYP3A Substrates
Generic name
Exemestane
Molecule type
small molecule
CAS number
107868-30-4
DrugBank ID
DB00990
Approval status
Approved drug, Investigational drug
ATC code
L02BG06
Primary indications
- For the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy
Product Snapshot
- Oral small‑molecule formulation supplied as various coated and film‑coated tablets
- Used in the management of advanced breast cancer progression in postmenopausal patients following prior endocrine therapy
- Approved in the US and Canada with additional investigational status in some contexts
Clinical Overview
Exemestane (CAS 107868-30-4) is an oral steroidal aromatase inhibitor used in the adjuvant and advanced treatment of hormone‑receptor‑positive breast cancer in postmenopausal women. It is indicated for advanced disease that has progressed following prior tamoxifen therapy. As a steroidal androgen derivative, its structure resembles androstenedione, enabling irreversible inactivation of aromatase.
Exemestane reduces estrogen production by permanently binding to the aromatase active site. In postmenopausal women, peripheral conversion of adrenal and ovarian androgens is the principal source of circulating estrogens, and suppression of this pathway lowers estrone and estradiol concentrations. The resulting estrogen deprivation slows growth of hormone‑dependent breast cancer. Exemestane does not measurably affect adrenal synthesis of corticosteroids or aldosterone at therapeutic concentrations and shows high selectivity within the steroidogenic pathway.
Pharmacodynamically, exemestane produces sustained reductions in circulating estrogen due to its irreversible mechanism, requiring de novo enzyme synthesis for recovery. Other selective aromatase inhibitors used in similar contexts include anastrozole and letrozole. Brand formulations have included Aromasin.
Following oral administration, absorption is moderate and increases with food. Exemestane undergoes extensive hepatic metabolism primarily through CYP3A4 and reductive pathways, forming inactive metabolites. Elimination is mainly via urine and feces. The terminal half‑life is approximately 24 hours, supporting once‑daily dosing in clinical practice. Exemestane shows high protein binding and a large apparent volume of distribution consistent with its lipophilic steroidal structure.
Safety considerations include dose‑related reductions in bone mineral density, menopausal symptoms, and potential elevation of hepatic enzymes. Use requires caution in patients with pre‑existing osteoporosis or hepatic impairment. Drug interactions involving CYP3A4 inducers may reduce systemic exposure.
For API procurement, sourcing should prioritize verified manufacturing routes for steroidal intermediates, control of related substances, and compliance with regional pharmacopeial specifications. Consistent impurity profiling and reliable supply chain documentation are essential for formulation and regulatory dossier development.
Exemestane reduces estrogen production by permanently binding to the aromatase active site. In postmenopausal women, peripheral conversion of adrenal and ovarian androgens is the principal source of circulating estrogens, and suppression of this pathway lowers estrone and estradiol concentrations. The resulting estrogen deprivation slows growth of hormone‑dependent breast cancer. Exemestane does not measurably affect adrenal synthesis of corticosteroids or aldosterone at therapeutic concentrations and shows high selectivity within the steroidogenic pathway.
Pharmacodynamically, exemestane produces sustained reductions in circulating estrogen due to its irreversible mechanism, requiring de novo enzyme synthesis for recovery. Other selective aromatase inhibitors used in similar contexts include anastrozole and letrozole. Brand formulations have included Aromasin.
Following oral administration, absorption is moderate and increases with food. Exemestane undergoes extensive hepatic metabolism primarily through CYP3A4 and reductive pathways, forming inactive metabolites. Elimination is mainly via urine and feces. The terminal half‑life is approximately 24 hours, supporting once‑daily dosing in clinical practice. Exemestane shows high protein binding and a large apparent volume of distribution consistent with its lipophilic steroidal structure.
Safety considerations include dose‑related reductions in bone mineral density, menopausal symptoms, and potential elevation of hepatic enzymes. Use requires caution in patients with pre‑existing osteoporosis or hepatic impairment. Drug interactions involving CYP3A4 inducers may reduce systemic exposure.
For API procurement, sourcing should prioritize verified manufacturing routes for steroidal intermediates, control of related substances, and compliance with regional pharmacopeial specifications. Consistent impurity profiling and reliable supply chain documentation are essential for formulation and regulatory dossier development.
Identification & chemistry
| Generic name | Exemestane |
|---|---|
| Molecule type | Small molecule |
| CAS | 107868-30-4 |
| UNII | NY22HMQ4BX |
| DrugBank ID | DB00990 |
Pharmacology
| Summary | Exemestane is an irreversible, steroidal inactivator of aromatase (CYP19A1), the enzyme responsible for converting androgens to estrogens in peripheral tissues. By permanently inhibiting aromatase, it produces sustained reductions in circulating estrogen levels without affecting adrenal corticosteroid or aldosterone synthesis. This estrogen deprivation limits growth of hormone‑dependent breast cancer that has progressed after prior endocrine therapy in postmenopausal patients. |
|---|---|
| Mechanism of action | Breast cancer cell growth may be estrogen-dependent. Aromatase (exemestane) is the principal enzyme that converts androgens to estrogens both in pre- and postmenopausal women. While the main source of estrogen (primarily estradiol) is the ovary in premenopausal women, the principal source of circulating estrogens in postmenopausal women is from conversion of adrenal and ovarian androgens (androstenedione and testosterone) to estrogens (estrone and estradiol) by the aromatase enzyme in peripheral tissues. Estrogen deprivation through aromatase inhibition is an effective and selective treatment for some postmenopausal patients with hormone-dependent breast cancer. Exemestane is an irreversible, steroidal aromatase inactivator, structurally related to the natural substrate androstenedione. It irreversibly binds to the active site causing permanent inhibition necessitating de novo synthesis to restore enzymatic function. Exemestane significantly lowers circulating estrogen concentrations in postmenopausal women, but has no detectable effect on the adrenal biosynthesis of corticosteroids or aldosterone. This reduction in serum and tumor concentrations of estrogen delays tumor growth and disease progression. Exemestane has no effect on other enzymes involved in the steroidogenic pathway up to a concentration at least 600 times higher than that inhibiting the aromatase enzyme. |
| Pharmacodynamics | Aromatase is an enzyme that converts hormones to estrogen in the body's adrenal glands. The aromatase inhibitors (AIs) are drugs that reduce estrogen levels by blocking the action of aromatase in the adrenal glands. The selective AIs (SAIs) selectively reduce levels of estrogen without interfering with levels of other steroid hormones that are produced by the adrenal gland. Drugs in this class include anastrozole (Arimidex ™), letrozole (Femara ™) and exemestane (Aromasin ™). |
Targets
| Target | Organism | Actions |
|---|---|---|
| Cytochrome P450 19A1 | Humans | inhibitor |
ADME / PK
| Absorption | 42% |
|---|---|
| Half-life | 24 hours |
| Protein binding | 90% (mainly α1-acid glycoprotein and albumin) |
| Metabolism | Hepatic |
Formulation & handling
- Oral small‑molecule API with very low aqueous solubility, typically formulated as compressed or coated tablets to aid manufacturability and dissolution.
- Solubility limitations may require careful selection of solid‑state form and excipients to ensure consistent oral absorption.
- Administration is recommended with food, indicating potential food‑dependent bioavailability considerations for formulation design.
Regulatory status
| Lifecycle | The API’s primary patents have expired in the United States (2011) and Canada (2021), indicating full loss of exclusivity across its marketed regions. These timelines suggest a mature market environment with established generic competition in both countries. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Exemestane was originally developed by a single originator, with related packaging and distribution handled by several affiliated entities. Branded products are established mainly in the US and Canada, indicating a concentrated North American market presence. Key patents have expired in both the US and Canada, supporting the availability of existing generic competition. |
|---|
Safety
| Toxicity | Convulsions |
|---|
High Level Warnings:
- Compound has been associated with convulsive events
- Operations should incorporate controls to minimize worker exposure to dust or aerosols
- Implement monitoring and containment measures suitable for neuroactive substances with potential CNS excitotoxicity
Exemestane 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.
Exemestane API manufacturers & distributors
Compare qualified Exemestane API suppliers worldwide. We currently have 14 companies offering Exemestane API, with manufacturing taking place in 7 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 |
|---|---|---|---|---|---|
| Cambrex | Producer | Italy | United States | CoA, GMP | 104 products |
| Cedarburg Pharma | Producer | United States | United States | CEP, CoA, GMP, USDMF | 12 products |
| Cipla | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 164 products |
| Coral Drugs | Producer | India | India | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, ISO9001, USDMF, WC, WHO-GMP | 25 products |
| Curia | Producer | United States | Spain | CEP, CoA, GMP, MSDS, USDMF | 106 products |
| Farmabios | Producer | Italy | Italy | CoA, GMP, ISO9001, USDMF | 58 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Humble Healthcaare | Producer | India | India | CoA | 30 products |
| Janssen Pharma | Producer | Belgium | Netherlands | CoA, GMP | 63 products |
| KRKA | Producer | Slovenia | Slovenia | CoA, GMP | 81 products |
| Qilu Antibiotics | Producer | China | China | CoA, WC | 33 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, MSDS, USDMF, WC | 757 products |
| Sun Pharma | Producer | India | India | CoA, GMP, USDMF, WC | 219 products |
| Symbiotec Pharma | Producer | India | India | CoA, GMP, WC | 50 products |
When sending a request, specify which Exemestane 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 Exemestane 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 Exemestane API
Sourcing
What matters most when sourcing GMP-grade Exemestane?
Key considerations include confirming that the manufacturer operates under GMP aligned with U.S. and Canadian regulatory requirements. It is also important to verify a reliable supply chain, as Exemestane production and distribution have historically been concentrated among a limited number of entities in North America. With patents expired and generic competition established, assessing documentation quality and regulatory completeness is essential.
Which documents are typically required when sourcing Exemestane API?
Request the core API documentation set: CoA (13 companies), GMP (11 companies), USDMF (6 companies), WC (5 companies), CEP (3 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Exemestane API?
Known or reported manufacturers for Exemestane: Global Pharma Tek, Coral Drugs. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Exemestane 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 Exemestane manufacturers?
Audit reports may be requested for Exemestane: 7 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Exemestane API on Pharmaoffer?
Reported supplier count for Exemestane: 13 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Exemestane API?
Production countries reported for Exemestane: India (6 producers), United States (2 producers), Italy (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Exemestane usually hold?
Common certifications for Exemestane suppliers: CoA (13 companies), GMP (11 companies), USDMF (6 companies), WC (5 companies), CEP (3 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Exemestane (CAS 107868-30-4) used for?
Exemestane is used for the adjuvant and advanced treatment of hormone‑receptor‑positive breast cancer in postmenopausal women. It is also used when advanced disease has progressed after prior tamoxifen therapy. By irreversibly inhibiting aromatase, it lowers estrogen levels and slows the growth of hormone‑dependent tumors.
Which therapeutic class does Exemestane fall into?
Exemestane belongs to the following therapeutic categories: Androstanes, Androstenes, Antineoplastic Agents, Antineoplastic and Immunomodulating Agents, Aromatase Inhibitors. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Exemestane mainly prescribed for?
The primary indications for Exemestane: For the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Exemestane work?
Breast cancer cell growth may be estrogen-dependent. Aromatase (Exemestane) is the principal enzyme that converts androgens to estrogens both in pre- and postmenopausal women. While the main source of estrogen (primarily estradiol) is the ovary in premenopausal women, the principal source of circulating estrogens in postmenopausal women is from conversion of adrenal and ovarian androgens (androstenedione and testosterone) to estrogens (estrone and estradiol) by the aromatase enzyme in peripheral tissues. Estrogen deprivation through aromatase inhibition is an effective and selective treatment for some postmenopausal patients with hormone-dependent breast cancer. Exemestane is an irreversible, steroidal aromatase inactivator, structurally related to the natural substrate androstenedione. It irreversibly binds to the active site causing permanent inhibition necessitating de novo synthesis to restore enzymatic function. Exemestane significantly lowers circulating estrogen concentrations in postmenopausal women, but has no detectable effect on the adrenal biosynthesis of corticosteroids or aldosterone. This reduction in serum and tumor concentrations of estrogen delays tumor growth and disease progression. Exemestane has no effect on other enzymes involved in the steroidogenic pathway up to a concentration at least 600 times higher than that inhibiting the aromatase enzyme.
What should someone know about the safety or toxicity profile of Exemestane?
Exemestane’s safety profile includes dose‑related reductions in bone mineral density, menopausal symptoms, and possible elevations in hepatic enzymes, warranting caution in patients with osteoporosis or hepatic impairment. At the API level, it has been associated with convulsive events, so manufacturing and handling should minimize exposure to dust or aerosols and use controls appropriate for neuroactive substances. Drug interactions with CYP3A4 inducers may reduce systemic exposure.
What are important formulation and handling considerations for Exemestane as an API?
Exemestane has very low aqueous solubility, so formulation typically focuses on selecting an appropriate solid‑state form and excipients that support manufacturability and dissolution. It is commonly prepared as compressed or coated tablets to achieve consistent performance. Because its absorption is influenced by food, formulations should account for food‑dependent bioavailability. Standard handling considerations include protecting the API from conditions that could alter its solid-state properties or dissolution behavior.
Is Exemestane a small molecule?
Exemestane is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Exemestane?
Exemestane’s very low aqueous solubility makes control of its solid‑state form important for maintaining consistent dissolution over shelf life. Stability can also depend on excipient selection, as these components help support manufacturability and dissolution performance. Because absorption is influenced by food, formulations are designed to maintain reliable release characteristics, but this relates to bioavailability rather than chemical instability.
Regulatory
Where is Exemestane approved or in use globally?
Exemestane is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Exemestane right now?
Exemestane is authorized for use in both Canada and the United States. The provided information does not indicate any active patent protections, suggesting no patent constraints within this context. Regulatory status in these regions supports its availability for approved indications.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Exemestane procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Exemestane. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Exemestane included in the PRO Data Insights coverage?
PRO Data Insights coverage for Exemestane: 363 verified transactions across 104 suppliers and 89 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Exemestane?
Market report availability for Exemestane: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
