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Glutathione | CAS No: 70-18-8 | GMP-certified suppliers
A medication that supports nutritional supplementation by addressing dietary shortages or imbalances and providing reliable glutathione supply for formulations in the US market.
Therapeutic categories
Primary indications
- For nutritional supplementation, also for treating dietary shortage or imbalance
Product Snapshot
- Glutathione is supplied as injectable, oral, topical, and cutaneous formulations including solutions, powders, tablets, capsules, creams, and patches
- It is used primarily for nutritional supplementation and to address dietary imbalance
- In the US it appears in mixed regulatory categories, including approved uses, investigational status, and nutraceutical market presence
Clinical Overview
Functionally, glutathione acts as a major intracellular reducing agent and participates in multiple enzymatic pathways. It serves as a cofactor for glutathione peroxidase, supporting detoxification of peroxides and protection against oxidative injury. It is also central to phase II hepatic biotransformation, forming hydrophilic conjugates with electrophilic xenobiotics, including endogenous metabolites and drug-derived intermediates. Its involvement in leukotriene synthesis further illustrates its regulatory functions in cellular signaling.
Within the glyoxalase system, glutathione is required for the conversion of methylglyoxal, a reactive by-product of metabolism, into D-lactate through sequential catalysis by glyoxalase I and II. Glutathione S-transferase enzymes catalyze conjugation reactions across cytosolic, microsomal, and mitochondrial compartments, although non-enzymatic conjugation also occurs with certain reactive species. A clinically important example is the scavenging of N-acetyl-p-benzoquinone imine, the toxic metabolite formed during acetaminophen overdose, a process that prevents covalent binding to cellular proteins. Depletion of reduced glutathione in this context underlies the rationale for N-acetylcysteine therapy.
Pharmacokinetic characteristics vary by route and formulation, and parenteral, oral, and inhaled products have been used in different regions. Reported safety considerations primarily relate to its biochemical reactivity, with attention to redox balance and sulfur-containing metabolite load.
In API procurement, emphasis should be placed on peptide integrity, control of oxidation state, and minimizing impurities that may arise from peptide degradation or thiol oxidation. Reliable sourcing requires adherence to validated manufacturing and storage conditions to preserve reduced glutathione content.
Identification & chemistry
| Generic name | Glutathione |
|---|---|
| Molecule type | Small molecule |
| CAS | 70-18-8 |
| UNII | GAN16C9B8O |
| DrugBank ID | DB00143 |
Pharmacology
| Summary | Glutathione is an endogenous tripeptide that functions as a central cellular redox buffer and detoxification cofactor, supporting reduction of peroxides through glutathione peroxidases and conjugation of electrophilic compounds via glutathione S‑transferases. It participates in hepatic biotransformation pathways and the glyoxalase system, enabling clearance of reactive metabolic by-products such as methylglyoxal. Through these actions, glutathione helps maintain cellular oxidative balance and supports metabolism of endogenous and xenobiotic substrates. |
|---|---|
| Mechanism of action | Glutathione (GSH) participates in leukotriene synthesis and is a cofactor for the enzyme glutathione peroxidase. It also plays a role in the hepatic biotransformation and detoxification process; it acts as a hydrophilic molecule that is added to other lipophilic toxins or wastes prior to entering biliary excretion. It participates in the detoxification of methylglyoxal, a toxic by-product of metabolism, mediated by glyoxalase enzymes. Glyoxalase I catalyzes the conversion of methylglyoxal and reduced glutathione to S-D-Lactoyl-glutathione. Glyoxalase II catalyzes the conversion of S-D-Lactoyl Glutathione to Reduced Glutathione and D-lactate. Glyoxalase I catalyzes the conversion of methylglyoxal and reduced glutathione to S-D-Lactoyl-glutathione. Glyoxalase II catalyzes the conversion of S-D-Lactoyl Glutathione to Reduced Glutathione and D-lactate. GSH is a cofactor of conjugation and reduction reactions that are catalyzed by glutathione S-transferase enzymes expressed in the cytosol, microsomes, and mitochondria. However, it is capable of participating in non-enzymatic conjugation with some chemicals, as it is hypothesized to do to a significant extent with n-acetyl-p-benzoquinone imine (NAPQI), the reactive cytochrome P450 reactive metabolite formed by toxic overdose of acetaminophen. Glutathione in this capacity binds to NAPQI as a suicide substrate and in the process detoxifies it, taking the place of cellular protein sulfhydryl groups which would otherwise be toxically adducted. The preferred medical treatment to an overdose of this nature, whose efficacy has been consistently supported in literature, is the administration (usually in atomized form) of N-acetylcysteine, which is used by cells to replace spent GSSG and allow a usable GSH pool. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Aldose reductase | Humans | |
| Matrix metalloproteinase-9 | Humans | |
| Cytochrome P450 3A4 | Humans |
ADME / PK
| Absorption | Research suggests that glutathione is not orally bioactive, and that very little of oral glutathione tablets or capsules is actually absorbed by the body. |
|---|
Formulation & handling
- Glutathione is a small peptide with very low lipophilicity, leading to poor oral absorption and frequent use of parenteral or topical formats.
- The thiol group is oxidation‑prone, so formulations commonly require antioxidant protection and oxygen‑controlled handling during reconstitution and storage.
- Parenteral powder-for-solution formats require careful control of pH and light exposure to maintain stability after reconstitution.
Regulatory status
| Lifecycle | I can draft the summary, but I need the patent‑expiry timing for the API. Please provide the key patent expiration year(s) or status so I can generate an accurate lifecycle summary. |
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| Markets | US |
|---|
Supply Chain
| Supply chain summary | Glutathione is not associated with a single originator company and is supplied by multiple U.S.-based packagers for use in a wide range of cosmetic, wellness, and supplement‑type formulations. Branded products appear primarily in non‑regulated or cosmetic markets rather than as approved prescription medicines in the US or EU. As an established endogenous compound with no active market‑defining patents, the category already functions as an open, competitive space for manufacturers and repackagers. |
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Safety
| Toxicity | ORL-MUS LD<sub>50</sub> 5000 mg/kg, IPR-MUS LD<sub>50</sub> 4020 mg/kg, SCU-MUS LD<sub>50</sub> 5000 mg/kg, IVN-RBT LD<sub>50</sub> > 2000 mg/kg, IMS-MUS LD<sub>50</sub> 4000 mg/kg |
|---|
- High acute-dose tolerability across oral, intraperitoneal, and subcutaneous routes (LD50 values generally 4000–5000 mg/kg in rodents) indicates low intrinsic acute toxicity under typical handling conditions
- Intravenous exposure in rabbits shows LD50 above 2000 mg/kg, supporting a low hazard profile but warranting routine controls to prevent unnecessary systemic exposure
- Dust or bulk material management should minimize inhalation or parenteral contact, as irritation or systemic uptake may occur at substantially elevated doses relative to nutritional use
Glutathione is a type of Dietary supplements
Dietary supplements are a subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) that play a crucial role in supporting overall health and well-being. These supplements are formulated to provide essential nutrients, vitamins, minerals, and other bioactive compounds that may be lacking in an individual's regular diet.
Dietary supplements are designed to bridge the nutritional gaps and promote optimal health by enhancing various bodily functions. They come in various forms, including tablets, capsules, powders, and liquids, and are commonly available over-the-counter.
These supplements often contain key ingredients such as vitamins (e.g., Vitamin C, Vitamin D), minerals (e.g., calcium, iron), antioxidants, herbal extracts, probiotics, and omega-3 fatty acids. Each ingredient is carefully selected for its specific health benefits and therapeutic effects.
When taken as directed, dietary supplements can support immune function, boost energy levels, promote healthy digestion, support cardiovascular health, and provide numerous other benefits. However, it's important to note that these supplements are not intended to replace a balanced diet but rather complement it.
Before incorporating dietary supplements into one's routine, it is recommended to consult with a healthcare professional to ensure they are appropriate for individual needs and to avoid potential interactions with any existing medications or health conditions.
In conclusion, dietary supplements are a vital category of pharmaceutical APIs that offer a convenient and effective way to supplement nutritional intake and promote overall well-being. When used responsibly, these supplements can play a valuable role in maintaining optimal health.
Glutathione (Dietary supplements), classified under Therapeutic Nutrients/Minerals/Electrolyte
Therapeutic Nutrients/Minerals/Electrolytes: A Comprehensive Technical DescriptionTherapeutic nutrients, minerals, and electrolytes are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used to support and enhance overall health and well-being. These compounds play a crucial role in maintaining the body's physiological balance, aiding in various metabolic processes, and addressing specific deficiencies.
Therapeutic nutrients encompass a broad range of substances, including vitamins, minerals, and electrolytes. Vitamins are organic compounds required in small quantities for proper bodily functions and are essential for growth, development, and disease prevention. Minerals, on the other hand, are inorganic substances that support numerous physiological processes, such as bone formation, nerve function, and energy production.
Electrolytes are minerals that carry an electric charge when dissolved in bodily fluids, including sodium, potassium, calcium, magnesium, and chloride. They play a crucial role in maintaining proper hydration, nerve impulses, muscle contractions, and pH balance.
Pharmaceutical APIs in the Therapeutic Nutrients/Minerals/Electrolyte category are designed to address specific deficiencies or imbalances in the body. These APIs are often used in the formulation of dietary supplements, nutritional products, and therapeutic treatments. They are manufactured under stringent quality control guidelines to ensure purity, potency, and bioavailability.
Therapeutic nutrients/minerals/electrolytes APIs are available in various forms, including tablets, capsules, powders, and liquid formulations. They are formulated to meet specific dosage requirements and can be combined with other ingredients for targeted health benefits.
Overall, therapeutic nutrients, minerals, and electrolytes APIs are essential components in maintaining optimal health. Their use helps address deficiencies, support bodily functions, and promote overall well-being. Pharmaceutical companies and healthcare professionals rely on these high-quality APIs to develop effective and safe products that contribute to a healthier population.
Glutathione API manufacturers & distributors
Compare qualified Glutathione API suppliers worldwide. We currently have 10 companies offering Glutathione 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 |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, FDA, MSDS, USDMF | 229 products |
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Blue Eyes Biotech Co., Lt... | Producer | United Kingdom | United Kingdom | CoA | 35 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Fuzhou Medcore Pharmaceut... | Distributor | China | China | CoA, MSDS | 9 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Kohjin Life Sciences | Producer | Japan | Japan | CoA, JDMF | 1 products |
| Reali Tide Biological Tec... | Producer | China | China | CoA, MSDS | 57 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, FDA, GMP, HALAL, ISO9001, Kosher, MSDS, USDMF, WC | 764 products |
When sending a request, specify which Glutathione 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 Glutathione 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 Glutathione API
Sourcing
What matters most when sourcing GMP-grade Glutathione?
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Technical
What is Glutathione (CAS 70-18-8) used for?
Which therapeutic class does Glutathione fall into?
What conditions is Glutathione mainly prescribed for?
How does Glutathione work?
What should someone know about the safety or toxicity profile of Glutathione?
What are important formulation and handling considerations for Glutathione as an API?
Is Glutathione a small molecule?
Are there special stability concerns for oral Glutathione?
Regulatory
Where is Glutathione approved or in use globally?
Pharmaoffer
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