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Methionine | CAS No: 63-68-3 | GMP-certified suppliers
A medication that supports nutritional and metabolic needs by providing essential amino acid supplementation and serves as an adjunct option in managing acetaminophen overdose.
Therapeutic categories
Amino AcidsAmino Acids, EssentialAmino Acids, NeutralAmino Acids, Peptides, and ProteinsAmino Acids, SulfurAntidotes
Generic name
Methionine
Molecule type
small molecule
CAS number
63-68-3
DrugBank ID
DB00134
Approval status
Approved drug, Nutraceutical drug
ATC code
V03AB26
Primary indications
- Used for protein synthesis including the formation of SAMe, L-homocysteine, L-cysteine, taurine, and sulfate
Product Snapshot
- Methionine is supplied as an oral small‑molecule amino acid and as parenteral solution formulations, including multiple injectable presentations
- It is used as a metabolic precursor to support protein synthesis pathways and related sulfur‑containing compound formation
- It is available in the US and Canada with classifications ranging from approved drug products to nutraceutical status
Clinical Overview
Methionine (CAS 63-68-3) is an essential sulfur-containing amino acid required for protein synthesis and for generating key metabolites including S‑adenosylmethionine, homocysteine, cysteine, taurine, and sulfate. It is classified among methionine and derivatives, encompassing compounds in which methionine undergoes modification at the amino or carboxyl group. As a nutritionally essential amino acid and an approved therapeutic agent in some regions, its use spans nutritional, metabolic, and specific clinical contexts.
Clinically, methionine is employed when exogenous supply is needed to maintain normal protein synthesis and sulfur-dependent metabolic pathways. Additional medical use includes its role as an adjunct in acetaminophen overdose protocols in some settings, where it serves as an alternative precursor for enhancing cysteine and subsequent glutathione availability.
Pharmacologically, methionine provides a source of organic sulfur and participates in methylation reactions through conversion to S‑adenosylmethionine. It exhibits chelating capacity for certain heavy metals. Reported biological effects include modulation of sulfur metabolism, contribution to hepatic lipid handling, and support of renal ammonia detoxification pathways, though these effects depend on nutritional and physiological status.
The mechanism related to protection against hepatotoxicity is attributed to its role as a precursor of cysteine and glutathione. Enhanced glutathione synthesis can support cellular redox balance under conditions of increased oxidative stress. Methionine itself also shows free radical scavenging activity related to its sulfur moiety.
Absorption occurs through active transport in the gastrointestinal tract, followed by wide systemic distribution and incorporation into proteins or metabolic pathways. Methionine undergoes trans-sulfuration and transmethylation reactions, with metabolites entering one‑carbon and sulfur metabolic cycles.
Safety considerations include the potential for elevated homocysteine concentrations with excessive intake, and caution is warranted in individuals with disorders of sulfur amino acid metabolism. Use in children or pregnant individuals requires adherence to established clinical guidance.
For API procurement, sourcing should focus on verified identity, control of stereochemical purity for the L‑isomer, and compliance with pharmacopeial specifications regarding residual solvents, heavy metals, and microbial quality.
Clinically, methionine is employed when exogenous supply is needed to maintain normal protein synthesis and sulfur-dependent metabolic pathways. Additional medical use includes its role as an adjunct in acetaminophen overdose protocols in some settings, where it serves as an alternative precursor for enhancing cysteine and subsequent glutathione availability.
Pharmacologically, methionine provides a source of organic sulfur and participates in methylation reactions through conversion to S‑adenosylmethionine. It exhibits chelating capacity for certain heavy metals. Reported biological effects include modulation of sulfur metabolism, contribution to hepatic lipid handling, and support of renal ammonia detoxification pathways, though these effects depend on nutritional and physiological status.
The mechanism related to protection against hepatotoxicity is attributed to its role as a precursor of cysteine and glutathione. Enhanced glutathione synthesis can support cellular redox balance under conditions of increased oxidative stress. Methionine itself also shows free radical scavenging activity related to its sulfur moiety.
Absorption occurs through active transport in the gastrointestinal tract, followed by wide systemic distribution and incorporation into proteins or metabolic pathways. Methionine undergoes trans-sulfuration and transmethylation reactions, with metabolites entering one‑carbon and sulfur metabolic cycles.
Safety considerations include the potential for elevated homocysteine concentrations with excessive intake, and caution is warranted in individuals with disorders of sulfur amino acid metabolism. Use in children or pregnant individuals requires adherence to established clinical guidance.
For API procurement, sourcing should focus on verified identity, control of stereochemical purity for the L‑isomer, and compliance with pharmacopeial specifications regarding residual solvents, heavy metals, and microbial quality.
Identification & chemistry
| Generic name | Methionine |
|---|---|
| Molecule type | Small molecule |
| CAS | 63-68-3 |
| UNII | AE28F7PNPL |
| DrugBank ID | DB00134 |
Pharmacology
| Summary | L‑methionine functions primarily as an essential sulfur‑containing amino acid supporting biosynthesis of cysteine and glutathione, contributing to cellular redox balance. Its proposed hepatoprotective activity is linked to antioxidant and free‑radical–scavenging properties of methionine and its metabolites during oxidative stress. Key metabolic targets include enzymes involved in methionine cycling and methylation pathways, such as methionine synthase, methionine synthase reductase, and betaine‑homocysteine S‑methyltransferases. |
|---|---|
| Mechanism of action | The mechanism of the possible anti-hepatotoxic activity of L-methionine is not entirely clear. It is thought that metabolism of high doses of acetaminophen in the liver lead to decreased levels of hepatic glutathione and increased oxidative stress. L-methionine is a precursor to L-cysteine. L-cysteine itself may have antioxidant activity. L-cysteine is also a precursor to the antioxidant glutathione. Antioxidant activity of L-methionine and metabolites of L-methionine appear to account for its possible anti-hepatotoxic activity. Recent research suggests that methionine itself has free-radical scavenging activity by virtue of its sulfur, as well as its chelating ability. |
| Pharmacodynamics | L-Methionine is a principle supplier of sulfur which prevents disorders of the hair, skin and nails; helps lower cholesterol levels by increasing the liver's production of lecithin; reduces liver fat and protects the kidneys; a natural chelating agent for heavy metals; regulates the formation of ammonia and creates ammonia-free urine which reduces bladder irritation; influences hair follicles and promotes hair growth. L-methionine may protect against the toxic effects of hepatotoxins, such as acetaminophen. Methionine may have antioxidant activity. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Methionine synthase reductase | Humans | product of |
| Methionine synthase | Humans | product of |
| Methionine aminopeptidase 2 | Humans | product of |
ADME / PK
| Absorption | Absorbed from the lumen of the small intestine into the enterocytes by an active transport process. |
|---|---|
| Metabolism | Hepatic |
Formulation & handling
- Oral forms are straightforward to formulate due to high aqueous solubility, with food taken alongside to support GI tolerance.
- Parenteral and intraperitoneal solutions require attention to pH and oxidation control, as sulfur‑containing amino acids are prone to oxidative degradation.
- Topical and emulsion preparations should ensure chemical stability of the free amino acid in aqueous systems and avoid exposure to strong oxidizing conditions during handling.
Regulatory status
| Lifecycle | Patent expiry in the US and Canada typically marks the transition of the API from protected to competitive markets, signaling maturation of the product lifecycle. As generic entrants expand in these regions following expiry, market dynamics generally shift toward established, price‑driven competition. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Methionine used in parenteral nutrition is supplied as a mature commodity ingredient, with packagers such as Amend and Spectrum Pharmaceuticals supporting distribution in the US and Canada. Branded parenteral nutrition formulations containing methionine are available across these markets, indicating established global use rather than reliance on a single originator. As a basic amino acid with no active patent protections, the ingredient already functions in an open, fully generic supply environment. |
|---|
Safety
| Toxicity | Doses of L-methionine of up to 250 mg daily are generally well tolerated. Higher doses may cause nausea, vomiting and headache. Healthy adults taking 8 grams of L-methionine daily for four days were found to have reduced serum folate levels and leucocytosis. Healthy adults taking 13.9 grams of L-methionine daily for five days were found to have changes in serum pH and potassium and increased urinary calcium excretion. Schizophrenic patients given 10 to 20 grams of L-methionine daily for two weeks developed functional psychoses. Single doses of 8 grams precipitated encephalopathy in patients with cirrhosis. |
|---|
High Level Warnings:
- High oral loads (≥8 g/day) have been associated with metabolic disturbances, including reduced serum folate, altered serum pH and potassium, and increased urinary calcium excretion
- Very high exposures (10–20 g/day) have produced neuropsychiatric effects such as functional psychoses in susceptible populations
- Single 8‑g doses have triggered encephalopathy in individuals with cirrhosis
Good Manufacturing Practices
Active pharmaceutical ingredients are made in GMP-certified manufacturing facilities. GMP stands for Good Manufacturing Practices and is the main standard in the pharmaceutical industry. cGMP or Current GMP means that the company complies with the most recent requirements/version of GMP. The WHO has its own guideline for GMP, the World Health Organization or WHO GMP. The authority that has audited the company can also be from a country like China (Chinese GMP) or from the EU (EU GMP), every authority has different GMP requirements.
L-Methionine 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-Methionine API manufacturers & distributors
Compare qualified L-Methionine API suppliers worldwide. We currently have 6 companies offering L-Methionine 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 |
|---|---|---|---|---|---|
| Amino GmbH | Producer | Germany | Germany | CoA, GMP | 17 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WC | 235 products |
| Evonik Rexim | Producer | China | Unknown | CEP, CoA, GMP, JDMF, USDMF, WC | 18 products |
| Sekisui Medical | Producer | Japan | Japan | CEP, CoA, GMP, JDMF, USDMF | 11 products |
| Senova Technology Co., Lt... | Producer | China | China | CoA, GMP, ISO9001, USDMF | 157 products |
| Wuhan Amino Acid Bio-Chem... | Producer | China | China | CoA | 32 products |
When sending a request, specify which L-Methionine 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-Methionine 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-Methionine API
Sourcing
What matters most when sourcing GMP-grade L-Methionine?
Key considerations include confirming GMP compliance and alignment with US and Canadian regulatory expectations for parenteral‑grade amino acids. Suppliers such as established packagers in these markets support a mature, generic supply chain, so verification of quality systems, documentation, and traceability is essential. Consistent parenteral‑nutrition specifications and secure distribution practices matter given its use in sterile formulations.
Which documents are typically required when sourcing L-Methionine API?
Request the core API documentation set: CoA (6 companies), GMP (5 companies), USDMF (4 companies), WC (2 companies), CEP (2 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce L-Methionine API?
Known or reported manufacturers for L-Methionine: Senova Technology Co., Ltd., Changzhou Comwin Fine Chemicals Co., Ltd. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for L-Methionine 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-Methionine manufacturers?
Audit reports may be requested for L-Methionine: 1 GMP audit report available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer L-Methionine API on Pharmaoffer?
Reported supplier count for L-Methionine: 6 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture L-Methionine API?
Production countries reported for L-Methionine: China (3 producers), Japan (1 producer), Germany (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of L-Methionine usually hold?
Common certifications for L-Methionine suppliers: CoA (6 companies), GMP (5 companies), USDMF (4 companies), WC (2 companies), CEP (2 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is L-Methionine (CAS 63-68-3) used for?
L-Methionine is used to supply an essential amino acid needed for protein synthesis and sulfur‑dependent metabolic pathways. It also serves as an adjunct treatment in some acetaminophen overdose protocols by providing a precursor for cysteine and glutathione synthesis. Additional uses include supporting methylation reactions and contributing organic sulfur for metabolic processes.
Which therapeutic class does L-Methionine fall into?
L-Methionine belongs to the following therapeutic categories: Amino Acids, Amino Acids, Essential, Amino Acids, Neutral, Amino Acids, Peptides, and Proteins, Amino Acids, Sulfur. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is L-Methionine mainly prescribed for?
The primary indications for L-Methionine: Used for protein synthesis including the formation of SAMe, L-homocysteine, L-cysteine, taurine, and sulfate. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does L-Methionine work?
The mechanism of the possible anti-hepatotoxic activity of L-Methionine is not entirely clear. It is thought that metabolism of high doses of acetaminophen in the liver lead to decreased levels of hepatic glutathione and increased oxidative stress. L-Methionine is a precursor to L-cysteine. L-cysteine itself may have antioxidant activity. L-cysteine is also a precursor to the antioxidant glutathione. Antioxidant activity of L-Methionine and metabolites of L-Methionine appear to account for its possible anti-hepatotoxic activity. Recent research suggests that L-Methionine itself has free-radical scavenging activity by virtue of its sulfur, as well as its chelating ability.
What should someone know about the safety or toxicity profile of L-Methionine?
L-Methionine is generally tolerated at nutritional or clinically guided doses, but high oral intakes can produce metabolic disturbances such as reduced serum folate, altered serum pH and potassium, and increased urinary calcium excretion. Very high exposures (about 10–20 g/day) have been linked to neuropsychiatric effects, and an 8‑g single dose has caused encephalopathy in people with cirrhosis. Excess intake may also raise homocysteine levels, so caution is advised in disorders of sulfur amino acid metabolism. Use in children or during pregnancy should follow established clinical guidance.
What are important formulation and handling considerations for L-Methionine as an API?
L-Methionine’s high aqueous solubility supports simple oral formulations, and coadministration with food can help with gastrointestinal tolerance. For parenteral or intraperitoneal solutions, pH control and protection from oxidative conditions are important because sulfur‑containing amino acids degrade readily. Topical or emulsion preparations should maintain chemical stability in aqueous systems and avoid exposure to strong oxidizers during handling.
Is L-Methionine a small molecule?
L-Methionine 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-Methionine?
Oral L-Methionine is generally straightforward to formulate due to its high aqueous solubility. The main consideration is avoiding exposure to strong oxidizing conditions during handling, as sulfur‑containing amino acids can undergo oxidative degradation. Co‑administration with food is used to support gastrointestinal tolerance.
Regulatory
Where is L-Methionine approved or in use globally?
L-Methionine 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-Methionine right now?
L-Methionine is regulated in both the United States and Canada under each country’s standard frameworks for amino acids and related ingredients. Its patent landscape typically relates to specific formulations, manufacturing processes, or therapeutic applications rather than the amino acid itself.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with L-Methionine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for L-Methionine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is L-Methionine included in the PRO Data Insights coverage?
PRO Data Insights coverage for L-Methionine: 24560 verified transactions across 2018 suppliers and 1259 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for L-Methionine?
Market report availability for L-Methionine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
