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Creatine | CAS No: 57-00-1 | GMP-certified suppliers
A medication that provides nutritional supplementation to address dietary deficiencies or imbalances, supporting energy metabolism in muscle and brain tissues.
Therapeutic categories
Primary indications
- For nutritional supplementation, also for treating dietary shortage or imbalance
Product Snapshot
- Creatine is supplied as an oral liquid formulation intended for nutritional supplementation
- Its primary application is to address dietary shortages or imbalances
- The product is approved for use in the US market and is classified as approved, investigational, and nutraceutical
Clinical Overview
Clinically, creatine is utilized as a nutritional supplement to address dietary deficiencies or imbalances. Its primary pharmacodynamic role involves serving as a reservoir for high-energy phosphate groups in the form of phosphocreatine, which rapidly regenerates adenosine triphosphate (ATP) during periods of increased energy demand, particularly anaerobic exercise. This mechanism is catalyzed by the enzyme creatine kinase, facilitating the reversible transfer of phosphate groups to adenosine diphosphate (ADP), thereby replenishing ATP needed for cellular processes.
Absorption of creatine following oral administration is efficient, and it distributes mainly to muscle tissue. Metabolism occurs locally within tissues where creatine is converted to phosphocreatine, while excretion of the metabolite creatinine takes place via the renal route. Pharmacokinetically, creatine demonstrates good bioavailability, though detailed parameters such as half-life can vary based on dosing and individual physiological factors.
Safety considerations include monitoring renal function, especially in populations with preexisting kidney disease, due to the increased creatinine load from supplementation. No significant toxicity has been widely documented under standard dosing regimens, though prolonged high-dose use warrants clinical oversight.
Creatine is categorized as an approved, investigational, and nutraceutical compound, appearing in drug classes such as amidines, amino acids, dietary supplements, and guanidines. It is distributed globally in various formulations aimed at both clinical nutritional support and sports supplementation.
For API procurement, sourcing should prioritize high purity and compliance with pharmacopeial standards to ensure consistent potency and safety. Verification of manufacturing processes, stability profiles, and impurity levels is critical to support regulatory submissions and quality assurance in finished product manufacture.
Identification & chemistry
| Generic name | Creatine |
|---|---|
| Molecule type | Small molecule |
| CAS | 57-00-1 |
| UNII | MU72812GK0 |
| DrugBank ID | DB00148 |
Pharmacology
| Summary | Creatine acts primarily as a substrate for creatine kinase enzymes, facilitating the formation of phosphocreatine, which serves as a rapid reserve for ATP regeneration in muscle and other tissues. It is synthesized endogenously and transported to energy-demanding organs where it supports short-term energy metabolism, especially under anaerobic conditions. Creatine supplementation addresses dietary deficiencies and may contribute to cellular energy homeostasis with potential neuroprotective and cardioprotective effects. |
|---|---|
| Mechanism of action | In the muscles, a fraction of the total creatine binds to phosphate - forming creatine phosphate. The reaction is catalysed by creatine kinase, and the result is phosphocreatine (PCr). Phosphocreatine binds with adenosine diphosphate to convert it back to ATP (adenosine triphosphate), an important cellular energy source for short term ATP needs prior to oxidative phosphorylation. |
| Pharmacodynamics | Creatine is a essential, non-proteinaceous amino acid derivative found in all animals. It is synthesized in the kidney, liver, and pancreas from L-arginine, glycine and L-methionine. Following its biosynthesis, creatine is transported to the skeletal muscle, heart, brain and other tissues. Most of the creatine is metabolized in these tissues to phosphocreatine (creatine phosphate). Phosphocreatine is a major energy storage form in the body. Supplemental creatine may have an energy-generating action during anaerobic exercise and may also have neuroprotective and cardioprotective actions. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Creatine kinase M-type | Humans | ligand |
| Creatine kinase U-type, mitochondrial | Humans | ligand |
| Creatine kinase B-type | Humans | ligand |
ADME / PK
| Half-life | 3 hours |
|---|
Formulation & handling
- Creatine is a small molecule intended for oral administration, typically delivered in liquid form.
- It exhibits high water solubility and low lipophilicity (LogP -2.9), facilitating formulation in aqueous solutions.
- Handling stability considerations primarily focus on maintaining dry storage conditions to preserve compound integrity prior to formulation.
Regulatory status
| Lifecycle | The API's main patent protection in the US is set to expire within the next two years, leading to increased generic competition and a transition toward a mature market phase. Market activity is expected to shift from brand-centric promotion to cost-focused product offerings. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for creatine involves multiple packagers within the US market, including National Vitamin Company, Professional Co., and Solace Nutrition. Branded products like Ginsamin Energy have a presence primarily in the US, with no noted activity in EU or other markets. The absence of originator companies and brand patents indicates that creatine is widely available as a generic ingredient without patent-related supply restrictions. |
|---|
Food & Drug Administration approved
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. FDA is important because it is intended to have companies produce their goods to certain standards and it presents this fact in a clear overview using FDA certificates. When a company is (US) FDA approved, it shows the American government has declared the API or medicine as safe and it can be sold, imported, or used in the United States. The USA is not the only country with a regulatory agency like FDA. Most other countries have agencies that are responsible for the national safety of pharmaceutical products. Some different kinds of organizations include:
EMA (European Medicines Agency, European Union)
MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom)
PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
CDSCO (Central Drugs Standard Control Organization, India)
Creatine 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.
Creatine (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.
Creatine API manufacturers & distributors
Compare qualified Creatine API suppliers worldwide. We currently have 1 companies offering Creatine API, with manufacturing taking place in 1 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 |
|---|---|---|---|---|---|
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA | 762 products |
When sending a request, specify which Creatine 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 Creatine 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.
