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Phenylalanine | CAS No: 63-91-2 | GMP-certified suppliers
A medication that supports management of certain depressive conditions and vitiligo, offered for reliable sourcing in key markets requiring consistent quality amino acid APIs.
Therapeutic categories
Amino AcidsAmino Acids, AromaticAmino Acids, CyclicAmino Acids, EssentialAmino Acids, Peptides, and ProteinsDietary Supplements
Generic name
Phenylalanine
Molecule type
small molecule
CAS number
63-91-2
DrugBank ID
DB00120
Approval status
Approved drug, Investigational drug, Nutraceutical drug
Primary indications
- L-phenylalanine may be helpful in some with depression
- It may also be useful in the treatment of vitiligo
- There is some evidence that L-phenylalanine may exacerbate tardive dyskinesia in some schizophrenic patients and in some who have used neuroleptic drugs
Product Snapshot
- Available as oral and parenteral small-molecule formulations, including solutions, tablets, emulsions, and injectable forms
- Primary uses include support in depressive symptoms and vitiligo, with noted potential to worsen tardive dyskinesia in susceptible populations
- Market presence includes approved and nutraceutical status in the US and Canada, with additional investigational references
Clinical Overview
Phenylalanine (CAS 63-91-2) is an essential aromatic amino acid required for protein synthesis and for the biosynthesis of several key endogenous molecules. It serves as a precursor for dopamine, norepinephrine, and melanin, and contributes to thyroxine formation. Clinically, L‑phenylalanine has been explored as an adjunct in certain depressive disorders and has been used in the management of vitiligo, although evidence remains variable. Reports indicate that it may worsen tardive dyskinesia in individuals with schizophrenia or in those previously exposed to neuroleptic therapy.
Its pharmacologic activity is primarily nutritional and metabolic. Through conversion to tyrosine and subsequent catecholamine synthesis, L‑phenylalanine can influence central neurotransmitter levels. Increased norepinephrine and dopamine availability is considered a potential basis for its observed antidepressant effects. The mechanism underlying its use in vitiligo is not clearly defined but may involve enhanced melanin production in affected skin.
After oral administration, L‑phenylalanine is efficiently absorbed via active transport in the small intestine and enters systemic circulation for incorporation into proteins or metabolic conversion. Distribution follows typical amino acid handling, with uptake into hepatic and extrahepatic tissues. It is metabolized mainly through hydroxylation to tyrosine and subsequent catecholamine pathways or via transamination and other amino acid degradation routes. Excess amounts are eliminated through normal nitrogen disposal processes.
Safety considerations include the need to avoid or strictly control intake in individuals with phenylketonuria due to impaired phenylalanine metabolism. Potential interactions with neuropsychiatric conditions and medications require cautious use. Toxicity at typical supplemental doses is uncommon, but high exposures may disturb amino acid balance or neurotransmitter pathways.
Phenylalanine is available globally as an approved amino acid for nutritional and pharmaceutical use, including in dietary supplements. For API procurement, sourcing should prioritize compliant manufacturing, control of enantiomeric purity, and verification of amino acid profile and impurity levels consistent with pharmacopeial specifications.
Its pharmacologic activity is primarily nutritional and metabolic. Through conversion to tyrosine and subsequent catecholamine synthesis, L‑phenylalanine can influence central neurotransmitter levels. Increased norepinephrine and dopamine availability is considered a potential basis for its observed antidepressant effects. The mechanism underlying its use in vitiligo is not clearly defined but may involve enhanced melanin production in affected skin.
After oral administration, L‑phenylalanine is efficiently absorbed via active transport in the small intestine and enters systemic circulation for incorporation into proteins or metabolic conversion. Distribution follows typical amino acid handling, with uptake into hepatic and extrahepatic tissues. It is metabolized mainly through hydroxylation to tyrosine and subsequent catecholamine pathways or via transamination and other amino acid degradation routes. Excess amounts are eliminated through normal nitrogen disposal processes.
Safety considerations include the need to avoid or strictly control intake in individuals with phenylketonuria due to impaired phenylalanine metabolism. Potential interactions with neuropsychiatric conditions and medications require cautious use. Toxicity at typical supplemental doses is uncommon, but high exposures may disturb amino acid balance or neurotransmitter pathways.
Phenylalanine is available globally as an approved amino acid for nutritional and pharmaceutical use, including in dietary supplements. For API procurement, sourcing should prioritize compliant manufacturing, control of enantiomeric purity, and verification of amino acid profile and impurity levels consistent with pharmacopeial specifications.
Identification & chemistry
| Generic name | Phenylalanine |
|---|---|
| Molecule type | Small molecule |
| CAS | 63-91-2 |
| UNII | 47E5O17Y3R |
| DrugBank ID | DB00120 |
Pharmacology
| Summary | L‑phenylalanine is an essential amino acid that serves as a precursor for catecholamine neurotransmitter synthesis, contributing to central norepinephrine and dopamine production. Its activity involves transport through large neutral amino acid carriers and metabolism by enzymes such as phenylalanine hydroxylase and tyrosine-related pathways. Possible effects in mood regulation and melanin production derive from these metabolic roles, though some mechanisms remain incompletely defined. |
|---|---|
| Mechanism of action | The supposed antidepressant effects of L-phenylalanine may be due to its role as a precursor in the synthesis of the neurotransmitters norepinephrine and dopamine. Elevated brain norepinephrine and dopamine levels are thought to be associated with antidepressant effects. The mechanism of L-phenylalanine's possible antivitiligo activity is not well understood. It is thought that L-phenylalanine may stimulate the production of melanin in the affected skin |
| Pharmacodynamics | Used by the brain to produce Norepinephrine, a chemical that transmits signals between nerve cells and the brain; keeps you awake and alert; reduces hunger pains; functions as an antidepressant and helps improve memory. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Tyrosine aminotransferase | Humans | |
| Large neutral amino acids transporter small subunit 2 | Humans | |
| Phenylalanine--tRNA ligase alpha subunit | Humans |
ADME / PK
| Absorption | Absorbed from the small intestine by a sodium dependent active transport process. |
|---|---|
| Metabolism | Hepatic. L-phenylalanine that is not metabolized in the liver is distributed via the systemic circulation to the various tissues of the body, where it undergoes metabolic reactions similar to those that take place in the liver. |
Formulation & handling
- Suitable for both oral and parenteral formulations; high aqueous solubility supports straightforward solution preparations for IV use.
- As a small, hydrophilic amino acid, it is chemically stable under typical formulation conditions and does not require special protection from hydrolysis.
- Solid‑state handling is uncomplicated, with good wettability and dissolution characteristics that facilitate incorporation into tablets or aqueous concentrates.
Regulatory status
| Lifecycle | Patent protections in the US and Canada have lapsed or are approaching expiry, indicating a mature stage in the product’s lifecycle. Both markets are characterized by established availability and increasing generic participation. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Phenylalanine used in parenteral nutrition is supplied as a mature commodity ingredient, with limited identified packagers in the dataset and no distinct originator‑driven branded product lineage. The branded formulations listed are marketed in the US and Canada, reflecting established global availability of amino‑acid infusion products rather than proprietary, patent‑protected technologies. Core components such as phenylalanine are long off‑patent, and generic or multi‑source supply is already standard in this segment. |
|---|
Safety
| Toxicity | L-phenylalanine will exacerbate symptoms of phenylketonuria if used by phenylketonurics. L-phenylalanine was reported to exacerbate tardive dyskinesia when used by some with schizophrenia. |
|---|
High Level Warnings:
- Use of L‑phenylalanine can amplify phenylalanine accumulation in phenylketonuria (PKU), warranting controls to prevent exposure in PKU‑related research or manufacturing contexts
- Reports indicate potential worsening of tardive dyskinesia in individuals with schizophrenia or prior neuroleptic exposure, suggesting heightened vigilance in facilities handling the compound for neuroactive applications
- Monitor processes for unintended inclusion in formulations where neuropsychiatric sensitivity to monoamine precursors may be a concern
L-Phenylalanine 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-Phenylalanine API manufacturers & distributors
Compare qualified L-Phenylalanine API suppliers worldwide. We currently have 8 companies offering L-Phenylalanine API, with manufacturing taking place in 3 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 |
| Evonik Rexim | Producer | China | Unknown | CoA, JDMF | 18 products |
| Sekisui Medical | Producer | Japan | Japan | CoA, JDMF | 11 products |
| Senova Technology Co., Lt... | Producer | China | China | CoA, GMP, ISO9001, USDMF | 157 products |
| Shanghai Kyowa A.A | Producer | China | China | CEP, CoA, GMP | 12 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-Phenylalanine 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-Phenylalanine 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-Phenylalanine API
Sourcing
What matters most when sourcing GMP-grade L-Phenylalanine?
When sourcing GMP‑grade L-Phenylalanine for parenteral nutrition, the key considerations are compliance with applicable US and Canadian regulatory and quality standards and reliable GMP documentation. Because it is a mature, multi‑source commodity ingredient, supplier qualification should focus on consistent quality, traceability, and auditability rather than proprietary distinctions. Limited identified packagers mean verification of packaging controls and supply chain transparency is also important.
Which documents are typically required when sourcing L-Phenylalanine API?
Request the core API documentation set: CoA (8 companies), USDMF (4 companies), GMP (4 companies), JDMF (3 companies), ISO9001 (2 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce L-Phenylalanine API?
Known or reported manufacturers for L-Phenylalanine: Senova Technology 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-Phenylalanine 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-Phenylalanine manufacturers?
Audit reports may be requested for L-Phenylalanine: 2 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer L-Phenylalanine API on Pharmaoffer?
Reported supplier count for L-Phenylalanine: 8 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture L-Phenylalanine API?
Production countries reported for L-Phenylalanine: China (4 producers), Japan (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of L-Phenylalanine usually hold?
Common certifications for L-Phenylalanine suppliers: CoA (8 companies), USDMF (4 companies), GMP (4 companies), JDMF (3 companies), ISO9001 (2 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is L-Phenylalanine (CAS 63-91-2) used for?
L-Phenylalanine is used as an essential amino acid for protein synthesis and as a metabolic precursor to tyrosine, catecholamines, and melanin. It has been investigated as an adjunct in certain depressive disorders and in the management of vitiligo. Its primary role is nutritional and metabolic, supporting endogenous neurotransmitter and pigment production.
Which therapeutic class does L-Phenylalanine fall into?
L-Phenylalanine belongs to the following therapeutic categories: Amino Acids, Amino Acids, Aromatic, Amino Acids, Cyclic, 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-Phenylalanine mainly prescribed for?
The primary indications for L-Phenylalanine: L-Phenylalanine may be helpful in some with depression, It may also be useful in the treatment of vitiligo, There is some evidence that L-Phenylalanine may exacerbate tardive dyskinesia in some schizophrenic patients and in some who have used neuroleptic drugs. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does L-Phenylalanine work?
The supposed antidepressant effects of L-Phenylalanine may be due to its role as a precursor in the synthesis of the neurotransmitters norepinephrine and dopamine. Elevated brain norepinephrine and dopamine levels are thought to be associated with antidepressant effects. The mechanism of L-Phenylalanine's possible antivitiligo activity is not well understood. It is thought that L-Phenylalanine may stimulate the production of melanin in the affected skin
What should someone know about the safety or toxicity profile of L-Phenylalanine?
L-Phenylalanine is generally well tolerated, but individuals with phenylketonuria require strict avoidance because impaired metabolism can lead to harmful accumulation. Reports indicate it may worsen tardive dyskinesia in people with schizophrenia or prior neuroleptic exposure, so use in neuropsychiatrically sensitive settings warrants caution. High exposures can disrupt amino‑acid balance or neurotransmitter pathways, although toxicity at typical doses is uncommon. Careful control of enantiomeric purity and exclusion from unintended formulations helps limit safety risks.
What are important formulation and handling considerations for L-Phenylalanine as an API?
L-Phenylalanine’s high aqueous solubility supports simple solution formulations for oral or intravenous use. Its chemical stability under typical formulation conditions means no special protection from hydrolysis is needed. In solid form, good wettability and dissolution characteristics aid incorporation into tablets or aqueous concentrates. Handling is generally straightforward for both solution and solid‑state processing.
Is L-Phenylalanine a small molecule?
L-Phenylalanine 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-Phenylalanine?
Oral L-Phenylalanine is chemically stable under typical formulation conditions and does not require special protection from hydrolysis. Its solid‑state handling is straightforward, with good wettability and dissolution that support conventional tablet or solution preparations. No special stability concerns beyond standard controls for amino‑acid–based formulations are indicated.
Regulatory
Where is L-Phenylalanine approved or in use globally?
L-Phenylalanine 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-Phenylalanine right now?
In Canada and the United States, L-Phenylalanine is regulated as an amino acid used in foods, dietary supplements, and certain pharmaceutical formulations, and must meet applicable quality and labeling standards. Its use in finished drug products is subject to standard regulatory requirements for excipients or active components, depending on formulation.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with L-Phenylalanine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for L-Phenylalanine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is L-Phenylalanine included in the PRO Data Insights coverage?
PRO Data Insights coverage for L-Phenylalanine: 2714 verified transactions across 601 suppliers and 456 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for L-Phenylalanine?
Market report availability for L-Phenylalanine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
