- Raw materials
- Amino acids
- L-Lysine
Filters
Filter
Custom request?
Type
Production region
Qualifications
Country of origin
L-Lysine API Manufacturers & Suppliers
12 verified results
Take control of your API sourcing
Submit a Special Inquiry and have Pharmaoffer activate verified suppliers.
Commercial-scale Suppliers
Producer
Produced in
India|
Employees: >600
|
Audit Report:
Certifications:
GMP
|
FDA|
MSDS|
BSE/TSE|
CoAAll certificates
GMP
FDA
MSDS
BSE/TSE
CoA
GDP
WC
Distributor
Produced in
China|
Employees: 50+
|
Audit Report:
Certifications:
GMP
|
USDMF|
ISO9001|
CoAAll certificates
GMP
USDMF
ISO9001
CoA
Take control of your API sourcing
Submit a Special Inquiry and have Pharmaoffer activate verified suppliers.
Producer
Produced in
China|
Employees: 25+
|
Audit Report:
Certifications:
GMP
|
USDMF|
CoAAll certificates
GMP
USDMF
CoA
Distributor
Produced in
China|
Audit Report:
Certifications:
CoA
All certificates
CoA
Producer
Produced in
India|
Employees: 25
|
Audit Report:
Certifications:
GMP
|
MSDS|
ISO9001|
WHO-GMP|
HALALAll certificates
GMP
MSDS
ISO9001
WHO-GMP
HALAL
CoA
Producer
Produced in
China|
Audit Report:
Certifications:
WC
|
CoAAll certificates
WC
CoA
Get full market intelligence report
€399,-
All L-Lysine data. Full access. Full negotiation power
Producer
Produced in
France|
Audit Report:
Certifications:
GMP
|
FDA|
CEP|
USDMF|
coaAll certificates
GMP
FDA
CEP
USDMF
coa
Producer
Produced in
Unknown|
Audit Report:
Certifications:
GMP
|
FDA|
CEP|
USDMF|
coaAll certificates
GMP
FDA
CEP
USDMF
coa
Get full market intelligence report
€399,-
All L-Lysine data. Full access. Full negotiation power
Producer
Produced in
Unknown|
Audit Report:
Certifications:
GMP
|
FDA|
CEP|
coaAll certificates
GMP
FDA
CEP
coa
Producer
Produced in
Spain|
Employees: 80+
|
Audit Report:
Certifications:
GMP
|
MSDS|
CoAAll certificates
GMP
MSDS
CoA
Producer
Produced in
China|
Audit Report:
Certifications:
coa
All certificates
coa
Producer
Produced in
China|
Audit Report:
Certifications:
WC
|
CoAAll certificates
WC
CoA
When insight is your advantage
Full data, full access, full negotiation power
Total market transparency
|
Supplier trade data access
|
Buyer / supplier flow comparison
Trusted by 30,000+ registered pharma professionals:
Reach multinationals, SMEs, compounding pharmacies & more!
Lysine | CAS No: 56-87-1 | GMP-certified suppliers
A medication that supports herpes simplex management and may aid bone health, offered as a nutritional supplement for varied clinical and parenteral formulation needs.
Therapeutic categories
Amino AcidsAmino Acids, BasicAmino Acids, DiaminoAmino Acids, EssentialAmino Acids, Peptides, and ProteinsBlood and Blood Forming Organs
Generic name
Lysine
Molecule type
small molecule
CAS number
56-87-1
DrugBank ID
DB00123
Approval status
Approved drug, Nutraceutical drug
ATC code
V03AF11
Primary indications
- Supplemental lysine has putative anti-herpes simplex virus activity
- There is preliminary research suggesting that it may have some anti-osteoporotic activity
Product Snapshot
- Lysine is available as an oral small‑molecule supplement and in multiple parenteral solution and emulsion formats for clinical nutrition use
- Its primary uses include nutritional supplementation with putative anti–herpes simplex virus activity and exploratory anti‑osteoporotic effects
- It is marketed in the US, EU, and Canada with status ranging from approved medicinal ingredient in parenteral nutrition to nutraceutical classification for oral forms
Clinical Overview
Lysine (CAS 56-87-1) is an essential L‑alpha‑amino acid required for protein synthesis and multiple anabolic processes. Humans cannot synthesize lysine, making dietary intake or supplementation necessary to maintain physiological levels. Clinically, lysine is used as a nutritional supplement and has been investigated for modulation of herpes simplex virus replication and for potential bone health applications based on preliminary evidence.
Pharmacologically, lysine contributes to collagen formation and supports calcium handling, antibody production, and enzymatic and hormonal pathways. Its ε‑amino group participates in hydrogen bonding, acid‑base catalysis, and multiple post‑translational modifications such as acetylation and methylation. Lysine‑derived hydroxylysine is a structural component of collagen, underscoring its relevance to connective tissue integrity.
The proposed mechanism underlying lysine’s influence on herpes simplex virus relates to the balance between lysine and arginine. Viral proteins are arginine rich, and experimental systems demonstrate that a high arginine‑to‑lysine ratio can enhance viral replication, while a higher lysine‑to‑arginine ratio may inhibit replication and cytopathic effects. Lysine also facilitates intestinal calcium absorption, which may indirectly affect bone metabolism.
Absorption occurs primarily in the small intestine via active transport. Lysine is widely distributed as a constituent of endogenous proteins and undergoes normal amino acid catabolism. Excess lysine is metabolized predominantly through the saccharopine pathway. Elimination occurs as metabolic products, with minimal renal excretion of unchanged amino acid under normal conditions.
Safety considerations include gastrointestinal intolerance at high supplemental doses and the theoretical risk of altering amino acid balance in patients with specific metabolic disorders. Lysine is generally well tolerated when used within established nutritional ranges, but data on long‑term high‑dose use remain limited.
Common usage contexts include oral dietary supplements and parenteral nutrition formulations. For API procurement, sourcing should prioritize identity verification, impurity control, chirality confirmation for the L‑isomer, and compliance with pharmacopeial specifications relevant to the intended route of administration.
Pharmacologically, lysine contributes to collagen formation and supports calcium handling, antibody production, and enzymatic and hormonal pathways. Its ε‑amino group participates in hydrogen bonding, acid‑base catalysis, and multiple post‑translational modifications such as acetylation and methylation. Lysine‑derived hydroxylysine is a structural component of collagen, underscoring its relevance to connective tissue integrity.
The proposed mechanism underlying lysine’s influence on herpes simplex virus relates to the balance between lysine and arginine. Viral proteins are arginine rich, and experimental systems demonstrate that a high arginine‑to‑lysine ratio can enhance viral replication, while a higher lysine‑to‑arginine ratio may inhibit replication and cytopathic effects. Lysine also facilitates intestinal calcium absorption, which may indirectly affect bone metabolism.
Absorption occurs primarily in the small intestine via active transport. Lysine is widely distributed as a constituent of endogenous proteins and undergoes normal amino acid catabolism. Excess lysine is metabolized predominantly through the saccharopine pathway. Elimination occurs as metabolic products, with minimal renal excretion of unchanged amino acid under normal conditions.
Safety considerations include gastrointestinal intolerance at high supplemental doses and the theoretical risk of altering amino acid balance in patients with specific metabolic disorders. Lysine is generally well tolerated when used within established nutritional ranges, but data on long‑term high‑dose use remain limited.
Common usage contexts include oral dietary supplements and parenteral nutrition formulations. For API procurement, sourcing should prioritize identity verification, impurity control, chirality confirmation for the L‑isomer, and compliance with pharmacopeial specifications relevant to the intended route of administration.
Identification & chemistry
| Generic name | Lysine |
|---|---|
| Molecule type | Small molecule |
| CAS | 56-87-1 |
| UNII | K3Z4F929H6 |
| DrugBank ID | DB00123 |
Pharmacology
| Summary | L‑lysine is an essential amino acid transported by cationic amino acid transporters and incorporated into proteins via lysine‑tRNA ligase. By altering the lysine‑to‑arginine ratio in tissues, it can reduce conditions favorable for herpes simplex virus replication, reflecting a nutrient‑dependent antiviral effect. It also supports general amino‑acid–dependent processes such as collagen formation and calcium absorption, which underlie its exploratory evaluation in skeletal and connective‑tissue research. |
|---|---|
| Mechanism of action | Proteins of the herpes simplex virus are rich in L-arginine, and tissue culture studies indicate an enhancing effect on viral replication when the amino acid ratio of L-arginine to lysine is high in the tissue culture media. When the ratio of L-lysine to L-arginine is high, viral replication and the cytopathogenicity of herpes simplex virus have been found to be inhibited. L-lysine may facilitate the absorption of calcium from the small intestine. |
| Pharmacodynamics | Insures the adequate absorption of calcium; helps form collagen ( which makes up bone cartilage & connective tissues); aids in the production of antibodies, hormones & enzymes. Recent studies have shown that Lysine may be effective against herpes by improving the balance of nutrients that reduce viral growth. A deficiency may result in tiredness, inability to concentrate, irritability, bloodshot eyes, retarded growth, hair loss, anemia & reproductive problems. |
Targets
| Target | Organism | Actions |
|---|---|---|
| High affinity cationic amino acid transporter 1 | Humans | |
| Cationic amino acid transporter 4 | Humans | |
| Cationic amino acid transporter 3 | Humans |
ADME / PK
| Absorption | Absorbed from the lumen of the small intestine into the enterocytes by an active transport process |
|---|---|
| Metabolism | Hepatic |
Formulation & handling
- Lysine is a small, highly water‑soluble amino acid suitable for simple aqueous oral formulations and for incorporation into parenteral nutrition solutions.
- High hydrophilicity (logP −3.2) supports stable IV solutions, though pH control is required to maintain compatibility with other amino acids and electrolytes.
- Solid oral forms are straightforward to process, with minimal sensitivity to food effects due to rapid dissolution and absorption.
Regulatory status
| Lifecycle | With core patent protections reaching or approaching expiry in Canada, the US, and the EU, the active pharmaceutical ingredient is entering a mature stage of its lifecycle. Market presence across all three regions suggests an environment moving toward broader competition and established generic availability. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Lysine is supplied by multiple packagers rather than a single originator company, reflecting its status as a well‑established amino acid ingredient used across parenteral nutrition products. Branded formulations are available in the US, EU, and Canada, indicating broad global distribution. As a non‑patented commodity API, lysine faces longstanding and widespread generic availability. |
|---|
L-Lysine 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-Lysine API manufacturers & distributors
Compare qualified L-Lysine API suppliers worldwide. We currently have 12 companies offering L-Lysine API, with manufacturing taking place in 5 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 | CEP, CoA, FDA, GMP, USDMF | 24 products |
| Bengbu BBCA Tushan | Producer | China | China | CoA, WC | 2 products |
| Evonik Rexim | Producer | China | France | CEP, CoA, FDA, GMP, USDMF | 18 products |
| Fuzhou Medcore Pharmaceut... | Distributor | China | China | CoA | 9 products |
| Innovative Healthcare | Producer | India | India | CoA, GMP, HALAL, ISO9001, MSDS, WHO-GMP | 10 products |
| Menadiona, S.L. | Producer | Spain | Spain | CoA, GMP, MSDS | 15 products |
| PharmaZell | Producer | Germany | India | BSE/TSE, CoA, FDA, GDP, GMP, MSDS, WC | 31 products |
| Senova Technology Co., Lt... | Producer | China | China | CoA, GMP, USDMF | 157 products |
| Shanghai Kyowa A.A | Producer | China | Unknown | CEP, CoA, FDA, GMP | 12 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, USDMF | 762 products |
| Tianjin Tianyao | Producer | China | China | CoA, WC | 24 products |
| Wuhan Amino Acid Bio-Chem... | Producer | China | China | CoA | 32 products |
When sending a request, specify which L-Lysine 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-Lysine 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-Lysine API
Sourcing
What matters most when sourcing GMP-grade L-Lysine?
When sourcing GMP‑grade L-Lysine, the key factors are compliance with GMP standards and alignment with regulatory expectations in Canada, the US, and the EU. Because L-Lysine is supplied by multiple packagers, confirming each supplier’s quality systems and documentation is essential. It is also important to verify that the material supports requirements for parenteral use and matches the specifications used in regional branded and generic products.
Which documents are typically required when sourcing L-Lysine API?
Request the core API documentation set: CoA (11 companies), GMP (7 companies), FDA (4 companies), USDMF (4 companies), CEP (3 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce L-Lysine API?
Known or reported manufacturers for L-Lysine: Senova Technology Co., Ltd., Fuzhou Medcore Pharmaceutical Technology Co. Ltd, Sinoway industrial Co.,Ltd, PharmaZell. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for L-Lysine 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-Lysine manufacturers?
Audit reports may be requested for L-Lysine: 5 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer L-Lysine API on Pharmaoffer?
Reported supplier count for L-Lysine: 11 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture L-Lysine API?
Production countries reported for L-Lysine: China (6 producers), India (1 producer), Spain (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of L-Lysine usually hold?
Common certifications for L-Lysine suppliers: CoA (11 companies), GMP (7 companies), FDA (4 companies), USDMF (4 companies), CEP (3 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is L-Lysine (CAS 56-87-1) used for?
L-Lysine is used as a nutritional supplement to support protein synthesis and other anabolic processes in individuals who cannot obtain adequate amounts from diet alone. It is also used in oral supplements and parenteral nutrition, and has been investigated for modulating herpes simplex virus replication through its interaction with arginine balance. Additionally, L-Lysine contributes to collagen formation and supports calcium handling, which underlies its use in contexts related to connective tissue integrity and bone health.
Which therapeutic class does L-Lysine fall into?
L-Lysine belongs to the following therapeutic categories: Amino Acids, Amino Acids, Basic, Amino Acids, Diamino, Amino Acids, Essential, Amino Acids, Peptides, and Proteins. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is L-Lysine mainly prescribed for?
The primary indications for L-Lysine: Supplemental L-Lysine has putative anti-herpes simplex virus activity, There is preliminary research suggesting that it may have some anti-osteoporotic activity. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does L-Lysine work?
Proteins of the herpes simplex virus are rich in L-arginine, and tissue culture studies indicate an enhancing effect on viral replication when the amino acid ratio of L-arginine to L-Lysine is high in the tissue culture media. When the ratio of L-Lysine to L-arginine is high, viral replication and the cytopathogenicity of herpes simplex virus have been found to be inhibited. L-Lysine may facilitate the absorption of calcium from the small intestine.
What should someone know about the safety or toxicity profile of L-Lysine?
L-Lysine is generally well tolerated at nutritional intakes, with gastrointestinal discomfort reported as the main issue at higher supplemental doses. Excess intake can alter amino acid balance, which is a concern in individuals with specific metabolic disorders. Long‑term safety data for high‑dose supplementation are limited, so use is typically guided by established nutritional ranges. In parenteral or API contexts, purity, identity, and control of impurities are important to minimize toxicity risks.
What are important formulation and handling considerations for L-Lysine as an API?
L-Lysine’s high water solubility allows use in simple aqueous oral formulations and in parenteral nutrition solutions. pH control is important in liquid preparations to maintain compatibility with other amino acids and electrolytes. Solid oral forms are easy to process because the API dissolves rapidly, with minimal sensitivity to food effects. Handling is generally straightforward due to its small, hydrophilic nature.
Is L-Lysine a small molecule?
L-Lysine 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-Lysine?
Oral L-Lysine has no special stability concerns beyond standard handling for highly water‑soluble amino acids. It is suitable for simple aqueous or solid oral formulations, and solid forms are straightforward to process. Rapid dissolution and absorption further limit formulation‑related instability.
Regulatory
Where is L-Lysine approved or in use globally?
L-Lysine is reported as approved in the following major regions: Canada, US, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with L-Lysine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for L-Lysine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is L-Lysine included in the PRO Data Insights coverage?
PRO Data Insights coverage for L-Lysine: 43235 verified transactions across 3323 suppliers and 2325 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for L-Lysine?
Market report availability for L-Lysine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
