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Pomalidomide | CAS No: 19171-19-8 | GMP-certified suppliers
A medication that treats multiple myeloma after prior therapies and Kaposi’s sarcoma in AIDS and HIV-negative patients by modulating immune response and inhibiting tumor growth.
Therapeutic categories
Primary indications
- Pomalidomide is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and have demonstrated disease progression on or within 60 days of completion of the last therapy
- It is also indicated for the treatment of Kaposi's sarcoma (KS) in AIDS patients who have failed highly active antiretroviral therapy (HAART) and for the treatment of KS in HIV-negative patients
Product Snapshot
- Pomalidomide is an oral small molecule delivered in capsule form
- It is primarily used for treating multiple myeloma and Kaposi's sarcoma
- The product is approved in key regulatory markets including the US, EU, and Canada
Clinical Overview
The primary indication for pomalidomide is in the treatment of multiple myeloma in patients who have received at least two prior therapies, including lenalidomide, and who have experienced disease progression on or within 60 days of the last therapy. Additionally, pomalidomide is indicated for Kaposi’s sarcoma (KS) in both AIDS patients unresponsive to highly active antiretroviral therapy (HAART) and HIV-negative individuals.
Pomalidomide exhibits enhanced potency in comparison to both thalidomide and lenalidomide, with approximately 100-fold and 10-fold greater activity, respectively. Its mechanism of action involves inhibition of tumor cell proliferation and induction of apoptosis, alongside immunomodulatory effects that enhance T cell and natural killer (NK) cell activity. The compound also suppresses the production of pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) by monocytes. The molecular target is cereblon, an E3 ubiquitin ligase substrate receptor; binding to cereblon alters ubiquitination and downstream protein degradation pathways. Pomalidomide also acts as a transcriptional inhibitor of cyclooxygenase-2 (COX-2).
Pharmacokinetic data indicate that pomalidomide is metabolized primarily via cytochrome P450 enzymes CYP1A2 and CYP3A4 and is a substrate for P-glycoprotein, factors important for drug-drug interaction considerations. The drug is mainly excreted renally. Given its narrow therapeutic index, careful monitoring for myelosuppression and other toxicities is warranted.
Safety concerns include teratogenicity, myelosuppression, and risk of venous thromboembolism, consistent with immunomodulatory drugs of this class. Pomalidomide is classified among immunosuppressive and antineoplastic agents, and vigilance is necessary in managing dosing and adverse event profiles.
From a formulation and sourcing standpoint, ensuring API quality involves verification of polymorphic form, residual solvents, and impurity profiles, particularly thalidomide-related degradation products. Consistency in purity and stability is critical, given the drug’s narrow therapeutic index and potent biological activity. Compliance with relevant pharmacopeial standards and regulatory requirements is essential for procurement and manufacturing.
Identification & chemistry
| Generic name | Pomalidomide |
|---|---|
| Molecule type | Small molecule |
| CAS | 19171-19-8 |
| UNII | D2UX06XLB5 |
| DrugBank ID | DB08910 |
Pharmacology
| Summary | Pomalidomide is an immunomodulatory agent targeting cereblon to inhibit ubiquitin ligase activity, leading to antineoplastic effects through tumor cell apoptosis and proliferation inhibition. It modulates immune responses by enhancing T cell and natural killer cell activity while suppressing pro-inflammatory cytokine production such as TNF-alpha and IL-6. Additionally, pomalidomide acts as a transcriptional inhibitor of COX-2 and exhibits higher potency compared to related agents thalidomide and lenalidomide. |
|---|---|
| Mechanism of action | Promalidomide is an immunomodulatory agent with antineoplastic activity. It is shown to inhibit the proliferation and induce apoptosis of various tumour cells. Furthermore, promalidomide enhances T cell and natural killer (NK) cell-mediated immunity and inhibited the production of pro-inflammatory cytokines, like TNF-alpha or IL-6, by monocytes. The primary target of promalidomide is thought to be the protein cereblon. It binds to this target and inhibits ubiquitin ligase activity. It is also a transcriptional inhibitor of COX2. |
| Pharmacodynamics | Pomalidomide is more potent than thalidomide (100-times) and lenalidomide (10-times). |
Targets
| Target | Organism | Actions |
|---|---|---|
| Protein cereblon | Humans | inhibitor |
| Tumor necrosis factor | Humans | inhibitor |
| Prostaglandin G/H synthase 2 | Humans | inhibitor |
ADME / PK
| Absorption | Pomalidomide is generally well absorbed. The major circulating component is the parent compound. Tmax, single oral dose = 2 -3 hours. When 4 mg of promalidomide is given to patients with multiple myeloma, the steady-state pharmacokinetic parameters are as follows: AUC(T) = 400 ng.hr/mL; Cmax = 75 ng/mL. Promalidomide accumulates following multiple doses. |
|---|---|
| Half-life | Healthy subjects = 9.4 hours; Multiple myeloma patients = 7.5 hours. |
| Protein binding | 12-44% protein bound. It is not concentration dependent. |
| Metabolism | Promalidomide is hepatically metabolized by CYP1A2 and CYP3A4. The metabolites are 26-fold less active than the parent compound. Minor contributions from CYP2C19 and CYP2D6 have been observed in vitro. |
| Route of elimination | When a single oral dose (2mg) is given to healthy subjects, 73% of the dose was eliminated in urine. 15% of the dose was eliminated in feces. 2% and 8% of the dose eliminated unchanged as pomalidomide in urine and feces, respectively. |
| Volume of distribution | Mean apparent volume of distribution (Vd/F), steady-state = 62 - 138 L |
| Clearance | Total body clearance = 7-10 L/hour |
Formulation & handling
- Pomalidomide is a small molecule administered orally in capsule form with varying strengths.
- The API exhibits moderate water solubility and a near-neutral LogP, indicating balanced hydrophilic-lipophilic properties.
- Food intake reduces absorption rate and peak concentration, but does not significantly affect overall exposure, allowing flexible dosing relative to meals.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is marketed in Canada, the EU, and the US, with key US patents having expired between 2018 and 2020, indicating a mature market with potential for generic competition. |
|---|
| Markets | Canada, EU, US |
|---|
Supply Chain
| Supply chain summary | Pomalidomide is supplied by multiple originator companies, with branded products available in the US, EU, and Canada markets. The presence of several US patents expiring between 2018 and 2020 indicates that generic competition is likely established or emerging in these regions. This reflects a mature supply landscape with both branded and generic manufacturers active globally. |
|---|
Safety
| Toxicity | Most common adverse reactions (≥30%) included fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain and pyrexia. |
|---|
- Handle with appropriate containment measures due to potential hematologic toxicities including neutropenia and anemia
- Implement respiratory protection to minimize exposure risk associated with adverse respiratory effects such as dyspnea and upper-respiratory tract infections
- Employ standard precautions for substances with gastrointestinal and systemic adverse effects including nausea, diarrhea, fatigue, and pyrexia
Pomalidomide is a type of Immunomodulators
Immunomodulators, a category of pharmaceutical active pharmaceutical ingredients (APIs), are substances that help regulate and modify the immune response of an individual. These compounds play a crucial role in treating various immune-related disorders and diseases. Immunomodulators work by either enhancing or suppressing the immune system, depending on the specific condition being treated.
Immunomodulators are used in the treatment of autoimmune disorders, such as rheumatoid arthritis, multiple sclerosis, and psoriasis. By suppressing the immune system, these APIs help reduce the overactive immune response associated with these conditions, thereby alleviating symptoms and preventing further damage to the body's tissues.
On the other hand, immunomodulators are also employed to boost the immune system in cases of immunodeficiency disorders. These APIs stimulate the immune response, enabling the body to better fight off infections and diseases. Additionally, immunomodulators are utilized in the prevention and treatment of organ transplant rejection, where they help modulate the immune system to accept the transplanted organ.
The development and production of immunomodulators require rigorous testing and quality control to ensure their safety and efficacy. Pharmaceutical companies carefully formulate these APIs into various dosage forms, including tablets, capsules, injections, and topical preparations, to cater to different patient needs.
In summary, immunomodulators form a vital category of pharmaceutical APIs that regulate and modify the immune system. With their ability to modulate immune responses, these compounds contribute significantly to the management and treatment of various immune-related disorders and diseases, improving the quality of life for many patients.
Pomalidomide API manufacturers & distributors
Compare qualified Pomalidomide API suppliers worldwide. We currently have 13 companies offering Pomalidomide API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, cDMF, CoA, GMP, MSDS | 229 products |
| Chongqing Jooe Co., Ltd. | Producer | China | China | CoA, FDA, GMP, MSDS | 10 products |
| Cipla | Producer | India | India | CoA, USDMF | 164 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CoA, FDA, GMP, MSDS, USDMF, WC | 170 products |
| Hetero Labs | Producer | India | India | CoA, GMP, USDMF, WC | 90 products |
| Janssen Pharma | Producer | Belgium | Netherlands | CoA, GMP | 63 products |
| MSN Labs. | Producer | India | India | CoA, GMP, USDMF, WC | 119 products |
| Mylan | Producer | India | India | CoA, USDMF | 201 products |
| Natco Pharma | Producer | India | India | CoA, USDMF | 40 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CoA, GMP, ISO9001, MSDS | 144 products |
| Shilpa Medicare Ltd | Producer | India | India | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WC | 54 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA | 762 products |
| Weijie Pharmaceuticals | Producer | China | China | CoA, USDMF | 15 products |
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