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Levocarnitine | CAS No: 541-15-1 | GMP-certified suppliers
A medication that treats primary and secondary carnitine deficiencies linked to metabolic disorders and end‑stage renal disease while also aiding digestive secretions and certain hyperlipoproteinemias.
Therapeutic categories
Primary indications
- For treatment of primary systemic carnitine deficiency, a genetic impairment of normal biosynthesis or utilization of levocarnitine from dietary sources, or for the treatment of secondary carnitine deficiency resulting from an inborn error of metabolism such as glutaric aciduria II, methyl malonic aciduria, propionic acidemia, and medium chain fatty acylCoA dehydrogenase deficiency
- Used therapeutically to stimulate gastric and pancreatic secretions and in the treatment of hyperlipoproteinemias
- Parenteral levocarnitine is indicated for the prevention and treatment of carnitine deficiency in patients with end-stage renal disease
Product Snapshot
- Levocarnitine is a small‑molecule active supplied in multiple oral, parenteral (intravenous and intramuscular), and topical formulations
- It is used for primary and secondary carnitine deficiency and related metabolic disorders, and for supportive gastrointestinal secretory and lipid‑management applications
- It is approved in the US and Canada, with some presentations noted as investigational
Clinical Overview
Pharmacologically, levocarnitine enables transport of long‑chain fatty acids across the inner mitochondrial membrane by forming acylcarnitine esters. This process supports mitochondrial beta‑oxidation and prevents intracellular accumulation of acyl groups. Levocarnitine also facilitates efflux of excess acyl moieties from tissues to urine, helping maintain metabolic homeostasis. Only the L‑isomer contributes to lipid metabolism, while the D‑isomer may competitively inhibit physiological activity.
Levocarnitine is synthesized endogenously from lysine and methionine in a vitamin C–dependent pathway. Exogenous administration restores plasma free carnitine concentrations and normalizes acylcarnitine ratios. It is primarily eliminated renally, and urinary excretion increases with rising plasma concentrations. Transport and disposition involve specific carnitine transporters and translocases, along with carnitine acetyltransferases and carnitine palmitoyltransferases. Levocarnitine is also characterized as an OAT3 substrate and OATP1B1 inhibitor, which may be relevant when evaluating transporter‑based interactions.
Safety considerations include monitoring for gastrointestinal effects and rare reports of myopathy or seizures, particularly in patients with underlying risk factors or significant metabolic derangements. Use of racemic D,L‑carnitine is discouraged due to interference with endogenous levocarnitine activity.
From a sourcing perspective, API procurement should confirm optical purity of the L‑isomer, control for residual solvents and related quaternary ammonium impurities, and ensure validated assays for enantiomeric and transporter‑relevant specifications.
Identification & chemistry
| Generic name | Levocarnitine |
|---|---|
| Molecule type | Small molecule |
| CAS | 541-15-1 |
| UNII | 0G389FZZ9M |
| DrugBank ID | DB00583 |
Pharmacology
| Summary | Levocarnitine facilitates mitochondrial fatty acid transport by shuttling long‑chain acyl groups across the inner mitochondrial membrane and exporting excess acyl compounds to prevent intracellular accumulation. Its activity depends on the L‑isomer and involves multiple carnitine transporters and transferases, including CPT1, CPT2, CACT, and OCTN transporters. These actions support cellular energy metabolism and address disorders characterized by impaired carnitine availability or utilization. |
|---|---|
| Mechanism of action | Levocarnitine can be synthesised within the body from the amino acids lysine or methionine. Vitamin C (ascorbic acid) is essential to the synthesis of carnitine. Levocarnitine is a carrier molecule in the transport of long chain fatty acids across the inner mitochondrial membrane. It also exports acyl groups from subcellular organelles and from cells to urine before they accumulate to toxic concentrations. Only the L isomer of carnitine (sometimes called vitamin BT) affects lipid metabolism. Levocarnitine is handled by several proteins in different pathways including carnitine transporters, carnitine translocases, carnitine acetyltransferases and carnitine palmitoyltransferases. |
| Pharmacodynamics | Levocarnitine is a carrier molecule in the transport of long chain fatty acids across the inner mitochondrial membrane. It also exports acyl groups from subcellular organelles and from cells to urine before they accumulate to toxic concentrations. Lack of carnitine can lead to liver, heart, and muscle problems. Carnitine deficiency is defined biochemically as abnormally low plasma concentrations of free carnitine, less than 20 µmol/L at one week post term and may be associated with low tissue and/or urine concentrations. Further, this condition may be associated with a plasma concentration ratio of acylcarnitine/levocarnitine greater than 0.4 or abnormally elevated concentrations of acylcarnitine in the urine. Only the L isomer of carnitine (sometimes called vitamin BT) affects lipid metabolism. The "vitamin BT" form actually contains D,L-carnitine, which competitively inhibits levocarnitine and can cause deficiency. Levocarnitine can be used therapeutically to stimulate gastric and pancreatic secretions and in the treatment of hyperlipoproteinemias. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Xanthine dehydrogenase/oxidase | Humans | |
| Liver carboxylesterase 1 | Humans | |
| Myeloperoxidase | Humans |
ADME / PK
| Absorption | Absolute bioavailability is 15% (tablets or solution). Time to maximum plasma concentration was found to be 3.3 hours. |
|---|---|
| Half-life | 17.4 hours (elimination) following a single intravenous dose. |
| Protein binding | None |
| Metabolism | After oral administration L-carnitine which is unabsorbed is metabolized in the gastrointestinal tract by bacterial microflora. Major metabolites include trimethylamine N-oxide and [3H]-gamma-butyrobetaine. |
| Route of elimination | Following a single intravenous dose, 73.1 +/- 16% of the dose was excreted in the urine during the 0-24 hour interval. Post administration of oral carnitine supplements, in addition to a high carnitine diet, 58-65% of the administered radioactive dose was recovered from urine and feces in 5-11 days. |
| Volume of distribution | The steady state volume of distribution (Vss) of an intravenously administered dose, above endogenous baseline levels, was calculated to be 29.0 +/- 7.1L. However this value is predicted to be an underestimate of the true Vss. |
| Clearance | Total body clearance was found to be a mean of 4L/h. |
Formulation & handling
- Levocarnitine is a highly hydrophilic small molecule suitable for high‑strength aqueous oral solutions and parenteral formulations due to its very low LogP and good water solubility.
- Parenteral products require attention to osmolarity and pH control because the quaternary ammonium structure is stable in water but can impact tonicity at high concentrations.
- Oral formulations may consider food‑related GI sensitivity, favoring buffered or diluted solutions to reduce irritation.
Regulatory status
| Lifecycle | The API’s core U.S. patents expired in 2021, indicating that the product is now in a mature post‑exclusivity phase. With availability in the US and Canada, the market is expected to reflect established generic competition. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Levocarnitine is supplied by multiple manufacturers and packagers, indicating a diversified production base rather than reliance on a single originator. Branded products such as Carnitor are available primarily in the US and Canada, with limited broader global market presence noted in the data. Key US patents expired in 2021, supporting the presence or further expansion of generic competition. |
|---|
Safety
| Toxicity | LD<sub>50</sub> > 8g/kg (mouse, oral). Adverse effects include hypertension, fever, tachycardia and seizures. |
|---|
- High oral LD50 in mice (›8 g/kg) indicates low acute toxicity, but elevated exposure may still trigger sympathetic stimulation
- Reported adverse responses include hypertension, fever, tachycardia, and seizure activity
- Appropriate controls should be used to limit exposure to aerosols or dust
Written Confirmation
When an API is imported into the European Union from elsewhere in the world, it should be accompanied by a “written confirmation” (WC). A written confirmation is a document set up by the health authorities of the country where the API was manufactured. After inspections were successfully performed under EU/GMP equivalent standards, the health authorities can provide a WC. These inspections will also have to regularly take place in the future.
L-Carnitine is a type of Means in metabolic disorders
The pharmaceutical API subcategory of means in metabolic disorders refers to a group of active pharmaceutical ingredients (APIs) that are utilized in the treatment of various metabolic disorders. Metabolic disorders are medical conditions that involve disruptions in the normal metabolic processes of the body, such as those related to glucose metabolism, lipid metabolism, or hormone regulation.
The means in metabolic disorders APIs encompass a diverse range of compounds that target specific pathways or enzymes involved in metabolic regulation. These APIs play a crucial role in managing conditions like diabetes, obesity, hyperlipidemia, and hormonal imbalances. They are often incorporated into medications designed to improve metabolic function and restore the balance of key biomolecules in the body.
Common APIs in this subcategory include biguanides, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, and sodium-glucose co-transporter 2 (SGLT2) inhibitors. These APIs exert their effects through various mechanisms such as enhancing insulin sensitivity, increasing insulin secretion, reducing glucose production, and promoting weight loss.
The development of means in metabolic disorders APIs involves extensive research and rigorous testing to ensure their efficacy, safety, and compatibility with existing treatment regimens. Pharmaceutical companies collaborate with researchers and regulatory authorities to conduct clinical trials and obtain necessary approvals before these APIs can be integrated into commercial medications.
In summary, means in metabolic disorders APIs are a vital component of pharmaceutical interventions aimed at managing metabolic disorders. By targeting specific metabolic pathways, these APIs contribute to improving patient outcomes and enhancing their overall quality of life.
L-Carnitine (Means in metabolic disorders), classified under Metabolic Bone Disease Agents
Metabolic Bone Disease Agents are a category of pharmaceutical active pharmaceutical ingredients (APIs) that are specifically designed to treat and manage conditions related to the bones and their metabolism. These agents play a crucial role in the treatment of various metabolic bone diseases, including osteoporosis, Paget's disease, and rickets.
The primary function of Metabolic Bone Disease Agents is to regulate bone remodeling and maintain bone health. They achieve this by targeting specific pathways involved in bone metabolism, such as osteoclast and osteoblast activity, calcium regulation, and vitamin D metabolism.
These APIs are commonly used in the development of medications, including oral tablets, injectables, and topical formulations, for the effective treatment of metabolic bone diseases. They are carefully formulated to optimize their pharmacokinetic and pharmacodynamic properties, ensuring maximum efficacy and minimal side effects.
Metabolic Bone Disease Agents encompass a range of substances, including bisphosphonates, selective estrogen receptor modulators (SERMs), calcitonin, and vitamin D analogs. These APIs act through different mechanisms to address specific aspects of bone health, such as inhibiting bone resorption, promoting bone formation, or regulating calcium levels.
In conclusion, Metabolic Bone Disease Agents are a vital category of pharmaceutical APIs used in the development of medications for the treatment and management of various metabolic bone diseases. These agents target specific pathways involved in bone metabolism to regulate bone remodeling, enhance bone health, and alleviate the symptoms associated with these conditions.
L-Carnitine API manufacturers & distributors
Compare qualified L-Carnitine API suppliers worldwide. We currently have 6 companies offering L-Carnitine 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 |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | CoA, GMP, MSDS, USDMF | 229 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, ISO9001, MSDS | 235 products |
| ChengDa Pharma | Producer | China | China | CoA, USDMF, WC | 1 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, MSDS | 767 products |
| Zhejiang Tiantai | Producer | China | China | CoA, WC | 7 products |
When sending a request, specify which L-Carnitine 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 L-Carnitine 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 L-Carnitine API
Sourcing
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