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Gluconolactone API Manufacturers & Suppliers
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Gluconolactone | CAS No: 90-80-2 | GMP-certified suppliers
A medication that serves as a calculi dissolution agent and acidifier with low toxicity, suitable for pharmaceutical use in formulations requiring sequestration and pH modulation.
Therapeutic categories
Product Snapshot
- Gluconolactone is supplied as a solution intended for irrigation use
- It is primarily utilized for applications requiring cleansing or chemical exfoliation
- The product is approved for use in the US market, with both approved and experimental status
Clinical Overview
Clinically, gluconolactone is not designated for a specific therapeutic indication. Its primary applications are in the food industry, where it functions as a sequestrant, acidifier, and curing, pickling, or leavening agent. It also finds utility as a calculi dissolution agent and in irrigation solutions due to its acidic properties.
Pharmacodynamic and detailed mechanism of action data are not specified for gluconolactone. However, its chemical nature as a polyhydroxy acid suggests potential biochemical interactions involving its acidity and metal ion chelation capabilities when used in various formulations.
Key ADME (absorption, distribution, metabolism, and excretion) parameters are not explicitly documented, consistent with its primary use as a food additive rather than a systemic pharmaceutical agent. It is generally recognized for its low toxicity profile, although specific safety and toxicity data pertinent to human pharmaceutical exposure are limited. It is considered safe under regulated use conditions in food applications.
Notable brand names for gluconolactone are not prominently documented, as the compound is primarily utilized as a generic ingredient rather than a proprietary drug substance. It may be encountered in experimental settings or approved formulations involving acidification or sequestration functions.
From an API sourcing and quality perspective, gluconolactone should be procured from suppliers complying with relevant pharmacopeial standards and good manufacturing practice (GMP) requirements. Purity, polymorphic form, residual solvents, and microbiological quality are critical parameters for pharmaceutical-grade material, given its integration into sensitive formulations. Analytical characterization should confirm the absence of contaminants and ensure batch-to-batch consistency.
Identification & chemistry
| Generic name | Gluconolactone |
|---|---|
| Molecule type | Small molecule |
| CAS | 90-80-2 |
| UNII | WQ29KQ9POT |
| DrugBank ID | DB04564 |
Pharmacology
Targets
| Target | Organism | Actions |
|---|---|---|
| Lactase-phlorizin hydrolase | Humans |
Formulation & handling
- Gluconolactone is a small molecule suitable for irrigation formulations rather than oral or injectable use.
- Its high water solubility and hydrophilic nature support aqueous-based formulation development.
- Due to its chemical structure, careful handling is recommended to maintain stability in solution, particularly under storage conditions avoiding contamination.
Regulatory status
| Lifecycle | The API is marketed in the US with patent protection recently expired, indicating entry into a mature market phase characterized by generic availability and established clinical use. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for gluconolactone includes originator companies producing branded products primarily for the US market, exemplified by Renacidin. These branded products have a presence mainly in the US, with limited information on other regions. Patent expiry status is not provided, so the extent of existing or upcoming generic competition cannot be determined from the current data. |
|---|
Gluconolactone is a type of Other dermatological agents
Others
Gluconolactone (Other dermatological agents), classified under Dermatological Agents
Dermatological agents are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used in the formulation of various skincare and dermatology products. These APIs are specifically designed to target and treat skin conditions, offering effective solutions for a wide range of dermatological concerns.
Dermatological agents encompass a diverse array of compounds, including corticosteroids, antifungal agents, antibacterials, retinoids, and immunomodulators. Each API within this category possesses unique properties and mechanisms of action, enabling them to address specific skin-related issues.
Corticosteroids, for instance, are potent anti-inflammatory agents commonly used in the treatment of skin conditions like eczema, psoriasis, and dermatitis. Antifungal agents, on the other hand, combat fungal infections such as athlete's foot or ringworm. Antibacterials are effective against bacterial infections, while retinoids promote skin cell turnover and treat acne and photoaging. Immunomodulators regulate the immune response, providing relief from conditions like atopic dermatitis.
The development and application of dermatological APIs involve rigorous research, clinical trials, and regulatory compliance. These APIs are typically integrated into topical creams, ointments, gels, and lotions, ensuring targeted delivery to the affected areas of the skin.
Dermatological agents play a crucial role in the management and treatment of various skin disorders. By harnessing the therapeutic properties of these APIs, pharmaceutical companies can develop innovative skincare products that cater to the diverse needs of individuals seeking effective dermatological solutions.
Gluconolactone API manufacturers & distributors
Compare qualified Gluconolactone API suppliers worldwide. We currently have 3 companies offering Gluconolactone API, with manufacturing taking place in 2 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 |
|---|---|---|---|---|---|
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Fujifilm Wako Pure Chemic... | Producer | Japan | Japan | BSE/TSE, CoA, ISO9001, MSDS | 55 products |
| Ruibang Laboraties | Producer | China | China | CoA, FDA, GMP | 10 products |
When sending a request, specify which Gluconolactone 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 Gluconolactone 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.
