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Proline | CAS No: 147-85-3 | GMP-certified suppliers
A medication that supports joint and tendon health while maintaining and strengthening heart muscle function through essential collagen synthesis.
Therapeutic categories
Primary indications
- L-Proline is extremely important for the proper functioning of joints and tendons and also helps maintain and strengthen heart muscles
Product Snapshot
- Proline is supplied primarily as injectable and emulsion formulations suitable for parenteral administration
- Its main applications involve supporting the structure and function of joints, tendons, and cardiac muscle tissue
- Proline products are marketed in Canada and the US as nutraceuticals without pharmaceutical drug approvals
Clinical Overview
Clinically, L-proline is integral to maintaining the structural integrity of connective tissues. It is a major constituent of collagen, the primary fibrous protein in cartilage, tendons, and skin, contributing to the proper functioning of joints, tendons, and heart muscles. Its role in collagen also supports repair processes in muscle, connective tissue, and skin. Additionally, proline participates in immune system function, although its specific immunomodulatory mechanisms remain less defined.
Pharmacodynamically, proline contributes to the maintenance of youthful skin and tissue repair by serving as a substrate for collagen synthesis. The mechanism of action involves its oxidation via proline oxidase in renal tissue, leading to ring-opening and conversion into L-glutamic acid. Conversely, L-ornithine and L-glutamic acid contribute to proline biosynthesis through the intermediate L-glutamic acid-gamma-semialdehyde. The cyclic structure of proline is critical to collagen’s triple helix formation and its biomechanical properties.
From an ADME perspective, proline follows typical amino acid metabolism pathways. It is absorbed efficiently from dietary sources, distributed widely as a proteinogenic amino acid, and metabolized primarily in the kidney and liver. Excretion occurs mostly via normal nitrogenous waste pathways.
Safety and toxicity profiles of proline are consistent with its endogenous nature and dietary amino acid status, with no significant adverse effects reported at physiological or supplemental doses. It is generally classified as a nutraceutical when used in supplement formulations.
Regarding sourcing and quality, pharmaceutical-grade proline APIs should comply with stringent purity criteria and be free from contaminants such as heavy metals or microbial impurities. Reliable suppliers must provide documentation on origin, synthesis route, and batch consistency to meet regulatory and formulation standards in global pharmaceutical manufacturing.
Identification & chemistry
| Generic name | Proline |
|---|---|
| Molecule type | Small molecule |
| CAS | 147-85-3 |
| UNII | 9DLQ4CIU6V |
| DrugBank ID | DB00172 |
Pharmacology
| Summary | L-Proline acts as a key amino acid involved in collagen synthesis and connective tissue maintenance, primarily targeting enzymes related to proline metabolism and hydroxylation. Its pharmacological activity supports the structural integrity and repair of cartilage, joints, tendons, and heart muscle. The compound influences multiple mitochondrial and cytosolic enzymes responsible for proline biosynthesis and post-translational collagen modification. |
|---|---|
| Mechanism of action | Glycogenic, by L-Proline oxidase in the kidney, it is ring-opened and is oxidized to form L-Glutamic acid. L-Ornithine and L-Glutamic acid are converted to L-Proline via L-Glutamic acid-gamma-semialdehyde. It is contained abundantly in collagen, and is intimately involved in the function of arthrosis and chordae. |
| Pharmacodynamics | L-Proline is a major amino acid found in cartilage and is important for maintaining youthful skin as well as repair of muscle, connective tissue and skin damage. It is also essential for the immune system, and for necessary balance of this formula. It is an essential component of collagen and is important for proper functioning of joints and tendons. L-Proline is extremely important for the proper functioning of joints and tendons. Helps maintain and strengthen heart muscles. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Pyrroline-5-carboxylate reductase 1, mitochondrial | Humans | |
| Bifunctional glutamate/proline--tRNA ligase | Humans | |
| Sodium- and chloride-dependent neutral and basic amino acid transporter B(0+) | Humans |
ADME / PK
| Metabolism | Hepatic |
|---|
Formulation & handling
- Proline is a small molecule amino acid primarily formulated for parenteral and intravenous injection routes.
- Due to its high water solubility and low lipophilicity (LogP -2.6), Proline solutions are suitable for aqueous injectable formulations without complex solubilization methods.
- Handling considerations include maintaining sterility and stability in solution, with no peptide or biologic degradation concerns noted.
Regulatory status
| Lifecycle | The API is currently marketed in Canada and the US, with patent protections expiring in these regions within the next 12 to 18 months, indicating the product is approaching the late stage of its patent lifecycle and increasing generic availability. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for Proline features multiple originator companies responsible for branded amino acid injection products primarily marketed in North America, including the US and Canada. The product range includes various formulations with and without electrolytes, indicating a tailored approach to clinical needs. Patent status is not specified, but the presence of a variety of branded formulations suggests existing or potential generic competition depending on patent expiry and regulatory approvals. |
|---|
L-Proline 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-Proline API manufacturers & distributors
Compare qualified L-Proline API suppliers worldwide. We currently have 9 companies offering L-Proline 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 |
|---|---|---|---|---|---|
| Ajinomoto | Producer | Japan | Unknown | CoA, JDMF, USDMF | 24 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, USDMF, WC | 18 products |
| Senova Technology Co., Lt... | Producer | China | China | CoA, GMP, ISO9001, USDMF | 157 products |
| Shanghai Kyowa A.A | Producer | China | China | CoA, WC | 12 products |
| Star Lake Bioscience | Producer | China | China | CoA, WC | 4 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-Proline 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-Proline 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.
