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Penicillamine | CAS No: 52-67-5 | GMP-certified suppliers
A medication that treats Wilson’s disease, cystinuria, and active rheumatoid arthritis by chelating metals and modulating immune responses to improve patient outcomes.
Therapeutic categories
Primary indications
- For treatment of Wilson's disease, cystinuria and active rheumatoid arthritis
Product Snapshot
- Penicillamine is available as oral capsules, coated capsules, tablets, gelatin-coated capsules, powder, and film-coated tablets
- It is primarily utilized for the treatment of Wilson's disease, cystinuria, and active rheumatoid arthritis
- The product is approved for use in the US and Canadian markets
Clinical Overview
Clinically, penicillamine is indicated for the treatment of Wilson’s disease, cystinuria, and active rheumatoid arthritis that is resistant to conventional therapies. In Wilson’s disease, it facilitates the removal of excess copper by forming complexes that enhance urinary copper excretion. For cystinuria, penicillamine reduces the concentration of urinary cystine through disulfide interchange reactions, generating more soluble penicillamine-cysteine disulfide complexes. In rheumatoid arthritis, penicillamine serves as an immunosuppressive agent, modulating immune responses by inhibiting macrophage activity, decreasing interleukin-1 production, reducing T-lymphocyte counts, and interfering with collagen cross-linking. The exact mechanism in rheumatoid arthritis remains incompletely understood, but the agent is noted to lower IgM rheumatoid factor without significant suppression of total serum immunoglobulins, and selectively depresses T-cell activity while sparing B-cell function.
Pharmacokinetic data indicate renal excretion as a primary elimination pathway, consistent with its role in chelation therapy. Safety considerations include the potential for muscle toxicity, myelosuppression, and hypersensitivity reactions, necessitating careful patient monitoring during treatment. The toxicity profile is influenced by the stereochemistry of the drug, underscoring the importance of using the D-isomer.
Penicillamine is included in several therapeutic categories, such as heavy metal antagonists and immunosuppressive agents, with regulatory approvals for its specified indications in multiple regions. For sourcing and quality control, ensuring high purity of the D-enantiomer and stringent stereochemical verification is critical to avoid toxicity associated with L-penicillamine. Additionally, APIs must comply with pharmacopeial standards and be free from residual solvents or related impurities that could affect therapeutic safety and efficacy.
Identification & chemistry
| Generic name | Penicillamine |
|---|---|
| Molecule type | Small molecule |
| CAS | 52-67-5 |
| UNII | GNN1DV99GX |
| DrugBank ID | DB00859 |
Pharmacology
| Summary | Penicillamine acts primarily as a copper-chelating agent, facilitating urinary excretion of excess copper in Wilson's disease. It reduces cystine accumulation in cystinuria through disulfide interchange reactions that increase cystine solubility. In rheumatoid arthritis, penicillamine modulates immune responses by inhibiting macrophage activity, reducing interleukin-1 levels, suppressing T-cell function, and disrupting collagen cross-linking, though its precise mechanism remains not fully defined. |
|---|---|
| Mechanism of action | Penicillamine is a chelating agent recommended for the removal of excess copper in patients with Wilson's disease. From in vitro studies which indicate that one atom of copper combines with two molecules of penicillamine. Penicillamine also reduces excess cystine excretion in cystinuria. This is done, at least in part, by disulfide interchange between penicillamine and cystine, resulting in formation of penicillamine-cysteine disulfide, a substance that is much more soluble than cystine and is excreted readily. Penicillamine interferes with the formation of cross-links between tropocollagen molecules and cleaves them when newly formed. The mechanism of action of penicillamine in rheumatoid arthritis is unknown although it appears to suppress disease activity. Unlike cytotoxic immunosuppressants, penicillamine markedly lowers IgM rheumatoid factor but produces no significant depression in absolute levels of serum immunoglobulins. Also unlike cytotoxic immunosuppressants which act on both, penicillamine in vitro depresses T-cell activity but not B-cell activity. |
| Pharmacodynamics | Penicillamine is a chelating agent used in the treatment of Wilson's disease. It is also used to reduce cystine excretion in cystinuria and to treat patients with severe, active rheumatoid arthritis unresponsive to conventional therapy. Penicillamine is used as a form of immunosuppression to treat rheumatoid arthritis. Penicillamine inhibits macrophages, decreases IL-1 and the number of T-lymphocytes, and prevents collagen cross linkage. In Wilson's disease it binds copper, allowing it to be eliminated in the urine. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Copper | Humans | chelator |
ADME / PK
| Absorption | rapidly but incompletely |
|---|---|
| Half-life | 1 hour |
| Protein binding | >80% (bound to plasma proteins) |
| Metabolism | Hepatic |
| Route of elimination | Excretion is mainly renal, mainly as disulfides. |
Formulation & handling
- Penicillamine is a small molecule administered orally, primarily formulated as capsules and tablets.
- It should be taken on an empty stomach to avoid decreased bioavailability due to food interactions.
- Due to its water solubility, formulation considerations should focus on maintaining stability and ensuring adequate dissolution.
Regulatory status
| Lifecycle | The API's primary patents have expired in the US and Canada, allowing for generic entry and increased market competition. As a result, the product is in a mature lifecycle stage in these markets. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Penicillamine is produced by a limited number of originator manufacturers, primarily serving the US and Canadian markets. The branded product Cuprimine is present in these regions, indicating a focused global presence. Given the availability of multiple packagers and manufacturers, alongside established brand presence, there is potential for existing or forthcoming generic competition. |
|---|
Penicillamine is a type of Indifferent resources
Indifferent resources, in the context of pharmaceutical active pharmaceutical ingredients (APIs), refer to the subcategory of materials used in the manufacturing process that do not react with or significantly affect the chemical properties of the API. These resources play a crucial role in ensuring the purity and stability of the final pharmaceutical product.
Indifferent resources include solvents, excipients, catalysts, and other auxiliary substances used during API synthesis or formulation. They are carefully selected to have minimal reactivity with the API, preserving its chemical integrity and therapeutic efficacy. The choice of indifferent resources depends on factors such as the API's chemical structure, solubility, and stability requirements.
By employing indifferent resources, pharmaceutical manufacturers can mitigate the risk of unwanted chemical reactions or degradation during the production and storage of APIs. This, in turn, enhances the quality and reliability of the pharmaceutical product.
In the pharmaceutical industry, the selection and use of indifferent resources are critical in complying with regulatory guidelines and ensuring the safety and efficacy of medications. Manufacturers must adhere to Good Manufacturing Practices (GMP) and perform comprehensive compatibility studies to identify suitable indifferent resources for their specific APIs.
Overall, indifferent resources serve as indispensable components in the pharmaceutical API manufacturing process, guaranteeing the production of high-quality, stable, and safe medications that meet stringent regulatory standards.
Penicillamine (Indifferent resources), classified under Others
The others category refers to pharmaceutical APIs that do not fall under specific classifications such as antibiotics, antivirals, analgesics, or cardiovascular drugs. These APIs are diverse in nature and serve various therapeutic purposes, making them a crucial component of pharmaceutical formulations.
Pharmaceutical companies develop APIs in the others category to address specific medical conditions or target novel biological pathways. This category includes APIs used in oncology, neurology, immunology, and other specialized areas of medicine. The APIs in this category are often designed to interact with specific molecular targets or receptors, providing targeted therapeutic effects.
The development of APIs in the others category requires extensive research and testing to ensure their efficacy, safety, and compliance with regulatory standards. Pharmaceutical manufacturers employ advanced techniques such as chemical synthesis, biotechnology, and genetic engineering to produce these APIs.
Due to the broad range of applications and therapeutic uses, APIs in the others category contribute significantly to the advancement of medical treatments. Pharmaceutical companies constantly strive to innovate and discover new APIs within this category to address unmet medical needs and improve patient outcomes.
In conclusion, the others category of pharmaceutical APIs encompasses a diverse range of active ingredients used in drug formulation. These APIs play a crucial role in developing innovative therapies across various therapeutic areas, contributing to advancements in healthcare and patient well-being.
Penicillamine API manufacturers & distributors
Compare qualified Penicillamine API suppliers worldwide. We currently have 6 companies offering Penicillamine 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 |
|---|---|---|---|---|---|
| ACE Japan | Producer | Japan | Japan | CoA | 76 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Jiangxi Dongfeng | Producer | China | China | CoA, WC | 3 products |
| NAVINTA | Producer | United States | Unknown | CoA, USDMF | 15 products |
| SEDANAH | Distributor | Jordan | World | CoA, GMP | 70 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
When sending a request, specify which Penicillamine 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 Penicillamine 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.
