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L-Leucine API from Chinese Manufacturers & Suppliers
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Producer
Produced in
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Employees: 25+
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Audit Report:
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GMP
|
USDMF|
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CoAAll certificates
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CoA
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Produced in
China|
Employees: 300+
|
Audit Report:
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GMP
|
USDMF|
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CoA
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Employees: 25
|
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Producer
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Audit Report:
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CoAAll certificates
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CoA
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USDMF|
CoAAll certificates
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CoA
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USDMF
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JDMF|
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JDMF
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Producer
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Japan|
Audit Report:
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JDMF
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CoAAll certificates
JDMF
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Leucine | CAS No: 61-90-5 | GMP-certified suppliers
A medication that supports patients after trauma or severe stress by helping prevent muscle protein breakdown for clinical nutrition and metabolic care applications.
Therapeutic categories
Amino AcidsAmino Acids, Branched-ChainAmino Acids, EssentialAmino Acids, Peptides, and ProteinsDietary SupplementsProteinogenic Amino Acids
Generic name
Leucine
Molecule type
small molecule
CAS number
61-90-5
DrugBank ID
DB00149
Approval status
Investigational drug, Nutraceutical drug
Primary indications
- Indicated to assist in the prevention of the breakdown of muscle proteins that sometimes occur after trauma or severe stress
Product Snapshot
- Leucine is supplied as an amino‑acid API for oral solid forms and for parenteral nutritional solutions and emulsions
- It is used in formulations intended to support muscle protein preservation under catabolic stress conditions
- In the US and Canada it is marketed primarily as a nutraceutical ingredient with investigational status for regulated therapeutic use
Clinical Overview
Leucine (CAS 61-90-5) is an essential branched‑chain amino acid required for normal protein synthesis and metabolic homeostasis. It cannot be synthesized endogenously and must be supplied through diet or supplementation. It is clinically used to support the prevention of muscle protein breakdown that can occur following trauma, critical illness, or severe physiological stress.
Leucine participates in the broader biology of branched‑chain amino acids, a group that undergoes initial catabolism in skeletal muscle rather than the liver. As an essential amino acid, leucine contributes to protein turnover and nitrogen balance and is a substrate in anabolic and energy‑producing pathways. It also plays a biochemical role in hemoglobin formation. In individuals with phenylketonuria, leucine can be administered as part of specialized amino acid formulas intended to replace restricted dietary protein sources.
Mechanistically, leucine undergoes transamination through a shared branched‑chain aminotransferase, generating the corresponding alpha‑keto acid. This intermediate is subsequently oxidized by branched‑chain alpha‑keto acid dehydrogenase, producing acyl‑CoA derivatives. Downstream leucine catabolism yields acetyl‑CoA and acetoacetyl‑CoA, classifying it as strictly ketogenic. Dysregulation of this enzymatic pathway underlies metabolic disorders such as maple syrup urine disease, in which defective dehydrogenase activity leads to accumulation of branched‑chain keto acids and associated neurotoxicity.
Absorption of leucine occurs through active transport in the small intestine, with rapid distribution into muscle tissue. It is not significantly protein bound and is largely metabolized via catabolic pathways in muscle and other tissues. Renal excretion primarily reflects downstream metabolites rather than the intact amino acid.
Leucine is generally well tolerated at physiologic intake levels. Excessive supplementation may pose risks in individuals with underlying metabolic disorders involving branched‑chain amino acid catabolism.
For API procurement, sourcing should confirm identity, purity, chirality, and compliance with pharmacopeial or regional quality standards, with particular attention to residual solvents, endotoxin levels, and suitability for nutritional or investigational use.
Leucine participates in the broader biology of branched‑chain amino acids, a group that undergoes initial catabolism in skeletal muscle rather than the liver. As an essential amino acid, leucine contributes to protein turnover and nitrogen balance and is a substrate in anabolic and energy‑producing pathways. It also plays a biochemical role in hemoglobin formation. In individuals with phenylketonuria, leucine can be administered as part of specialized amino acid formulas intended to replace restricted dietary protein sources.
Mechanistically, leucine undergoes transamination through a shared branched‑chain aminotransferase, generating the corresponding alpha‑keto acid. This intermediate is subsequently oxidized by branched‑chain alpha‑keto acid dehydrogenase, producing acyl‑CoA derivatives. Downstream leucine catabolism yields acetyl‑CoA and acetoacetyl‑CoA, classifying it as strictly ketogenic. Dysregulation of this enzymatic pathway underlies metabolic disorders such as maple syrup urine disease, in which defective dehydrogenase activity leads to accumulation of branched‑chain keto acids and associated neurotoxicity.
Absorption of leucine occurs through active transport in the small intestine, with rapid distribution into muscle tissue. It is not significantly protein bound and is largely metabolized via catabolic pathways in muscle and other tissues. Renal excretion primarily reflects downstream metabolites rather than the intact amino acid.
Leucine is generally well tolerated at physiologic intake levels. Excessive supplementation may pose risks in individuals with underlying metabolic disorders involving branched‑chain amino acid catabolism.
For API procurement, sourcing should confirm identity, purity, chirality, and compliance with pharmacopeial or regional quality standards, with particular attention to residual solvents, endotoxin levels, and suitability for nutritional or investigational use.
Identification & chemistry
| Generic name | Leucine |
|---|---|
| Molecule type | Small molecule |
| CAS | 61-90-5 |
| UNII | GMW67QNF9C |
| DrugBank ID | DB00149 |
Pharmacology
| Summary | Branched‑chain amino acids, including leucine, are essential dietary substrates metabolized primarily in skeletal muscle, where their catabolism generates reducing equivalents that support cellular energy production. Leucine engages shared BCAA transamination and dehydrogenase pathways before diverging into ketogenic end products, while also serving as a nutrient signal that influences muscle protein turnover. Its therapeutic intent centers on supporting muscle protein preservation in settings of physiological stress. |
|---|---|
| Mechanism of action | This group of essential amino acids are identified as the branched-chain amino acids, BCAAs. Because this arrangement of carbon atoms cannot be made by humans, these amino acids are an essential element in the diet. The catabolism of all three compounds initiates in muscle and yields NADH and FADH2 which can be utilized for ATP generation. The catabolism of all three of these amino acids uses the same enzymes in the first two steps. The first step in each case is a transamination using a single BCAA aminotransferase, with a-ketoglutarate as amine acceptor. As a result, three different a-keto acids are produced and are oxidized using a common branched-chain a-keto acid dehydrogenase, yielding the three different CoA derivatives. Subsequently the metabolic pathways diverge, producing many intermediates. The principal product from valine is propionylCoA, the glucogenic precursor of succinyl-CoA. Isoleucine catabolism terminates with production of acetylCoA and propionylCoA; thus isoleucine is both glucogenic and ketogenic. Leucine gives rise to acetylCoA and acetoacetylCoA, and is thus classified as strictly ketogenic. There are a number of genetic diseases associated with faulty catabolism of the BCAAs. The most common defect is in the branched-chain a-keto acid dehydrogenase. Since there is only one dehydrogenase enzyme for all three amino acids, all three a-keto acids accumulate and are excreted in the urine. The disease is known as Maple syrup urine disease because of the characteristic odor of the urine in afflicted individuals. Mental retardation in these cases is extensive. Unfortunately, since these are essential amino acids, they cannot be heavily restricted in the diet; ultimately, the life of afflicted individuals is short and development is abnormal The main neurological problems are due to poor formation of myelin in the CNS. |
| Pharmacodynamics | An essential amino acid. (Claim) Leucine helps with the regulation of blood-sugar levels, the growth and repair of muscle tissue (such as bones, skin and muscles), growth hormone production, wound healing as well as energy regulation. It can assist to prevent the breakdown of muscle proteins that sometimes occur after trauma or severe stress. It may also be beneficial for individuals with phenylketonuria - a condition in which the body cannot metabolize the amino acid phenylalanine |
Targets
| Target | Organism | Actions |
|---|---|---|
| Probable leucine--tRNA ligase, mitochondrial | Humans | |
| Leucine carboxyl methyltransferase 2 | Humans | |
| Leucine carboxyl methyltransferase 1 | Humans |
Formulation & handling
- Highly water‑soluble small molecule amino acid suitable for aqueous intravenous and parenteral solutions without need for solubilizers.
- Chemically stable solid with low logP, generally straightforward to handle; hygroscopicity control may be needed for dry‑blend or topical formulations.
- Oral forms are feasible due to good solubility and neutral amino‑acid profile, with minimal food‑related formulation constraints.
Regulatory status
| Lifecycle | Patent‑expiry timing was not provided, but with the API marketed in both Canada and the US, the product appears to be in a commercially established phase. Market maturity will largely depend on whether key patents have expired, which would typically signal or coincide with broader generic entry in these regions. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Leucine is a widely established amino‑acid ingredient with no active patent protection, so sourcing is typically supported by multiple generic‑grade manufacturers rather than a single originator. Branded parenteral nutrition products containing leucine are available in the US and Canada, indicating a mature and globally diffuse supply chain for this amino‑acid component. The absence of exclusivity suggests that broad generic competition already exists across regions. |
|---|
L-Leucine is a type of Amino acids
Amino acids are an essential category of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the pharmaceutical industry. These organic compounds are the building blocks of proteins and play a crucial role in various biological processes. With their increasing popularity and therapeutic potential, amino acids have become a focus of research and development in drug discovery.
Amino acids can be classified into two main categories: essential and non-essential. Essential amino acids cannot be synthesized by the body and must be obtained from dietary sources or through pharmaceutical supplementation. Non-essential amino acids, on the other hand, can be synthesized by the body itself.
Pharmaceutical-grade amino acids are produced through a variety of methods, including extraction from natural sources, fermentation, and chemical synthesis. They undergo rigorous quality control procedures to ensure purity, efficacy, and safety. The most common amino acids used as APIs include lysine, valine, leucine, isoleucine, phenylalanine, and methionine, among others.
Amino acids have diverse applications in the pharmaceutical industry. They are widely used as ingredients in parenteral nutrition formulations, where they provide essential nutrients to patients who cannot consume food orally. Additionally, amino acids are utilized in the development of protein-based drugs, such as monoclonal antibodies and recombinant proteins. These pharmaceutical proteins often require specific amino acid sequences to achieve desired therapeutic effects.
In conclusion, amino acids are a vital category of pharmaceutical APIs, playing a significant role in protein synthesis, nutrition, and the development of protein-based drugs. With their extensive applications and growing demand, amino acids continue to contribute to advancements in the pharmaceutical industry.
L-Leucine API manufacturers & distributors
Compare qualified L-Leucine API suppliers worldwide. We currently have 10 companies offering L-Leucine API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| Ajinomoto | Producer | Japan | Unknown | CoA, JDMF, USDMF | 24 products |
| Amino GmbH | Producer | Germany | Unknown | CoA, GMP, USDMF | 17 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WC | 235 products |
| Evonik Rexim | Producer | China | Unknown | CoA, JDMF, WC | 18 products |
| Innovative Healthcare | Producer | India | India | CoA, GMP, HALAL, ISO9001, MSDS, WHO-GMP | 10 products |
| Sekisui Medical | Producer | Japan | Japan | CoA, JDMF | 11 products |
| Senova Technology Co., Lt... | Producer | China | China | CoA, GMP, ISO9001, USDMF | 157 products |
| Tianjin Tianyao | Producer | China | China | CoA, WC | 24 products |
| Wuhan Amino Acid Bio-Chem... | Producer | China | China | CoA | 32 products |
| Wuxi Jinghai Amino Acid C... | Producer | China | China | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WC | 15 products |
When sending a request, specify which L-Leucine 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-Leucine 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-Leucine API
Sourcing
What matters most when sourcing GMP-grade L-Leucine?
Key considerations include confirming GMP compliance from manufacturers and verifying that the facility meets Canada and US regulatory expectations for amino‑acid ingredients. Quality documentation, including certificates of analysis and evidence of consistent impurity control, is essential. Given the mature, multi‑source supply chain, assessing supplier qualification and supply reliability is also important.
Which documents are typically required when sourcing L-Leucine API?
Request the core API documentation set: CoA (10 companies), USDMF (5 companies), GMP (5 companies), WC (4 companies), ISO9001 (4 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce L-Leucine API?
Known or reported manufacturers for L-Leucine: Senova Technology Co., Ltd., Xi'an Tian Guangyuan Biotech Co.,Ltd, Changzhou Comwin Fine Chemicals Co., Ltd, Wuxi Jinghai Amino Acid Co., Ltd. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for L-Leucine API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for L-Leucine manufacturers?
Audit reports may be requested for L-Leucine: 3 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer L-Leucine API on Pharmaoffer?
Reported supplier count for L-Leucine: 10 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture L-Leucine API?
Production countries reported for L-Leucine: China (6 producers), Japan (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of L-Leucine usually hold?
Common certifications for L-Leucine suppliers: CoA (10 companies), USDMF (5 companies), GMP (5 companies), WC (4 companies), ISO9001 (4 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is L-Leucine (CAS 61-90-5) used for?
L-Leucine is used to support normal protein synthesis and help limit muscle protein breakdown during trauma, critical illness, or other severe physiological stress. It contributes to nitrogen balance, hemoglobin formation, and energy‑producing metabolic pathways. In phenylketonuria, it is included in specialized amino acid formulas that replace restricted dietary protein sources.
Which therapeutic class does L-Leucine fall into?
L-Leucine belongs to the following therapeutic categories: Amino Acids, Amino Acids, Branched-Chain, Amino Acids, Essential, Amino Acids, Peptides, and Proteins, Dietary Supplements. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is L-Leucine mainly prescribed for?
The primary indications for L-Leucine: Indicated to assist in the prevention of the breakdown of muscle proteins that sometimes occur after trauma or severe stress. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does L-Leucine work?
This group of essential amino acids are identified as the branched-chain amino acids, BCAAs. Because this arrangement of carbon atoms cannot be made by humans, these amino acids are an essential element in the diet. The catabolism of all three compounds initiates in muscle and yields NADH and FADH2 which can be utilized for ATP generation. The catabolism of all three of these amino acids uses the same enzymes in the first two steps. The first step in each case is a transamination using a single BCAA aminotransferase, with a-ketoglutarate as amine acceptor. As a result, three different a-keto acids are produced and are oxidized using a common branched-chain a-keto acid dehydrogenase, yielding the three different CoA derivatives. Subsequently the metabolic pathways diverge, producing many intermediates. The principal product from valine is propionylCoA, the glucogenic precursor of succinyl-CoA. IsoL-Leucine catabolism terminates with production of acetylCoA and propionylCoA; thus isoL-Leucine is both glucogenic and ketogenic. L-Leucine gives rise to acetylCoA and acetoacetylCoA, and is thus classified as strictly ketogenic. There are a number of genetic diseases associated with faulty catabolism of the BCAAs. The most common defect is in the branched-chain a-keto acid dehydrogenase. Since there is only one dehydrogenase enzyme for all three amino acids, all three a-keto acids accumulate and are excreted in the urine. The disease is known as Maple syrup urine disease because of the characteristic odor of the urine in afflicted individuals. Mental retardation in these cases is extensive. Unfortunately, since these are essential amino acids, they cannot be heavily restricted in the diet; ultimately, the life of afflicted individuals is short and development is abnormal The main neurological problems are due to poor formation of myelin in the CNS.
What should someone know about the safety or toxicity profile of L-Leucine?
L-Leucine is generally well tolerated at normal dietary or supplemental levels and is metabolized through standard branched‑chain amino acid pathways. Excess intake may be unsafe for individuals with disorders of BCAA catabolism, such as defects in branched‑chain alpha‑keto acid dehydrogenase, because accumulation of metabolic intermediates can lead to neurotoxicity. Its safety profile is otherwise typical for an essential amino acid when used within physiologic ranges.
What are important formulation and handling considerations for L-Leucine as an API?
L-Leucine is a highly water‑soluble, chemically stable amino acid suitable for aqueous intravenous and other parenteral solutions without requiring solubilizers. In solid form it is generally easy to handle, though hygroscopicity control may be necessary for dry‑blend or topical preparations. Oral formulations are feasible due to its good solubility and neutral amino‑acid characteristics, with minimal food‑related constraints.
Is L-Leucine a small molecule?
L-Leucine is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral L-Leucine?
Oral L-Leucine is generally chemically stable and does not present unusual stability issues. Its primary consideration is hygroscopicity, which may require moisture control in dry‑blend formulations. Good aqueous solubility and a neutral amino‑acid profile mean no additional stability aids are typically needed for oral dosage forms.
Regulatory
Where is L-Leucine approved or in use globally?
L-Leucine is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for L-Leucine right now?
In the US and Canada, L-Leucine is regulated as a dietary ingredient and is generally permitted for use in supplements when compliant with applicable safety and labeling requirements. As a naturally occurring amino acid, it is not subject to market‑exclusive patents, though isolated process or formulation patents may exist independently of the ingredient itself. Overall, it is widely available without active proprietary restrictions.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with L-Leucine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for L-Leucine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is L-Leucine included in the PRO Data Insights coverage?
PRO Data Insights coverage for L-Leucine: 2679 verified transactions across 674 suppliers and 486 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for L-Leucine?
Market report availability for L-Leucine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
