Hyaluronic acid API Manufacturers & Suppliers
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Hyaluronic acid | CAS No: 9004-61-9 | GMP-certified suppliers
A medication that supports relief of osteoarthritis‑related knee pain, dry eye discomfort, and aids wound and skin irritation management across diverse clinical formulations.
Therapeutic categories
Primary indications
- The intra-articular preparations of hyaluronic acid are indicated for knee pain associated with osteoarthritis
- Hyaluronic acid is used in cosmetic applications to prevent and reduce the appearance of wrinkles on the face, and as a dermal filler to correct facial imperfections or other imperfections on other parts of the body
- It is frequently an ingredient in topical applications for wound healing and symptomatic treatment of skin irritation from various causes
- Hyaluronic acid may also be indicated in ophthalmological preparations or oral capsules to treat discomfort caused by dry eyes or conjunctivitis and for its protective qualities during and before eye surgery
Product Snapshot
- Hyaluronic acid is available as injectable viscoelastic material, topical formulations, ophthalmic solutions, and oral forms
- It is used for osteoarthritis-related knee pain, aesthetic dermal filling, wound and skin care, ocular lubrication, and other protective applications
- It is approved in the US for human and veterinary use across multiple formulation categories
Clinical Overview
Pharmacologically, hyaluronic acid provides long-acting lubrication, shock absorption, joint stabilization, and water retention. These properties support synovial viscosity, ocular surface hydration, and local tissue protection. In cosmetic applications, its hygroscopic and viscoelastic characteristics increase tissue volume and improve structural integrity.
The mechanism of action depends on molecular weight. High molecular weight forms function mainly as passive structural polymers, maintaining hydration and viscoelasticity. Lower molecular weight forms may act as signaling molecules with context-dependent pro- or anti-inflammatory effects. Hyaluronic acid interacts with multiple receptors including CD44, RHAMM, ICAM-1, LYVE-1, and HARE (Stabilin-2), influencing cell migration, proliferation, and extracellular matrix homeostasis.
Absorption and distribution depend on route and molecular size. Intra-articular products primarily remain within the joint space before gradual enzymatic degradation. Ophthalmic and topical preparations act locally with minimal systemic absorption. Metabolism occurs via hyaluronidases and free radical-mediated pathways, yielding oligosaccharides subsequently cleared through lymphatic and hepatic mechanisms.
Safety considerations include local injection-site reactions, transient inflammation, and rare hypersensitivity. Dermal fillers may cause edema or nodule formation, often related to product characteristics or injection technique. Intra-articular use carries low systemic risk but may trigger pseudoseptic reactions in isolated cases.
For API procurement, suppliers should control molecular weight distribution, purity, endotoxin levels, and source material characterization, as these parameters directly influence clinical performance and regulatory acceptability.
Identification & chemistry
| Generic name | Hyaluronic acid |
|---|---|
| Molecule type | Small molecule |
| CAS | 9004-61-9 |
| UNII | S270N0TRQY |
| DrugBank ID | DB08818 |
Pharmacology
| Summary | Hyaluronic acid acts as both a structural and signaling molecule, with high‑molecular‑weight forms providing viscoelastic support and hydration and lower‑molecular‑weight forms modulating inflammatory and cellular responses. Its therapeutic activity is mediated primarily through binding to CD44, RHAMM, ICAM‑1, LYVE‑1, and Stabilin‑2, influencing cell survival, migration, and extracellular matrix organization. These interactions underpin its roles in tissue lubrication, volume maintenance, and surface protection across joint, dermal, and ophthalmic applications. |
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| Mechanism of action | General principles and hyaluronic acid receptor binding Hyaluronic acid works by two basic mechanisms: serving as a passive structural molecule or serving as signaling molecule, depending on the molecule size. The physicochemical properties of high molecular weight HA contribute to passive structural effects, demonstrating hygroscopicity and viscoelasticity and improving hydration, water balance, and structural integrity. As a signalling molecule interacting with proteins, HA causes several opposing effects based on molecular weight: pro- or anti-inflammatory effects, promotion or inhibition of cell migration, and activating or inhibiting cell division. Hyaluronic acid exerts its therapeutic effects through binding to three primary types of cell surface receptors: CD44 (a membrane glycoprotein), the receptor for hyaluronate-mediated motility (RHAMM), and the Intercellular Adhesion Molecule 1 (ICAM-1). CD44 is considered the most widely distributed receptor for hyaluronic acid, demonstrating cellular interactions with osteopontin, collagen, and matrix metalloproteinases (MMPs). High and low molecular weight hyaluronic acids demonstrate differing molecular and cellular mechanisms in their interaction with CD44 receptors. Some examples of these effects include modification of chondrocyte survival pathways in addition to alteration of apoptosis pathways. Lymphatic vessel endothelial hyaluronan receptor (LYVE-1), and hyaluronic acid receptor for endocytosis (HARE), (also known as Stabilin-2) also bind to hyaluronic acid. Hyaluronic acid for skin conditions and cosmetics Hyaluronic acid's anionic proprieties cause it to attract water and induce swelling, increasing tissue volume and skin structural integrity. The aging process is associated with reduced production of skin hyaluronic acid and collagen, causing the appearance of wrinkles and the loss of facial volume. Dermal fillers of hyaluronic acid replace lost tissue volume, imparting a full and youthful appearance to skin that has lost its elasticity. Hyaluronic acid fillers contain cross-linked hyaluronic acid particles, rendering a concentrated substance with resistance to various forms of physical and chemical breakdown. The cosmetic benefits of hyaluronic acid filler may last up to 6 months, depending on the brand and technique used for injection.Additionally, dermal hyaluronic acid fillers are known to increase the production of fibroblasts, supporting wound healing and offering relief from irritating and inflammatory skin conditions. Hyaluronic acid for joint pain Most cells in the human body are capable of synthesizing HA. It is a primary component of the extracellular matrix (ECM) and can be found in bone marrow, cartilage, and synovial fluid in joints.In osteoarthritis, the concentration of naturally occurring hyaluronic acid gradually decreases, lowering the viscosity of synovial fluid that protects joints from excess friction. Administration of intra-articular hyaluronic acid increases viscosity of synovial joint fluid, reducing friction and subsequently relieving painful arthritic symptoms. Hyaluronic acid for ophthalmic conditions and ophthalmological procedures Solutions of hyaluronic acid with a concentration greater than 0.1% moisturize the surface of the eyes to treat symptoms of dry eye while improving the stabilization of tear film, replenishing deficiencies of HA, reducing friction, and preventing binding of foreign substances to the ocular tissue.Hyaluronic acid is frequently used during and after ophthalmological surgeries and plays important roles by virtue of its moisturizing, viscoelastic, and protective properties. It promotes tissue healing of the corneal epithelium and other parts of the eye following ophthalmological surgery, minimizing the risk of adhesions and free radical formation. |
| Pharmacodynamics | HA has long-acting lubricant, shock absorbing, joint stabilizing, and water balancing properties.It is similar to the naturally occurring glycosaminoglycan (GAG) in joints. Hyaluronic acid works by acting as a lubricant and shock absorber, facilitating joint mobility and thereby reducing osteoarthritic pain. Hyaluronic acid has antioxidative, anti-inflammatory, and analgesic effects.The water-balancing properties and viscoelasticity of hyaluronic acid are beneficial in cosmetic injections, imparting volume and reducing the appearance of imperfections and wrinkles.Due to the abovementioned properties, HA has a protective effect on the eyes and cornea. |
Targets
| Target | Organism | Actions |
|---|---|---|
| CD44 antigen | Humans | binder |
| Intercellular adhesion molecule 1 | Humans | inhibitor, binder |
| Hyaluronan mediated motility receptor | Humans | binder |
ADME / PK
| Absorption | There is limited information in the literature regarding the human absorption and pharmacokinetics of hyaluronic acid.When administered to rats in the oral form, hyaluronic acid is broken down to oligosaccharides by intestinal bacteria and absorbed in the colon.In pharmacokinetic studies of beagle dogs, HA was readily absorbed and rapidly excreted.When applied topically, HA with low molecular weight ranging from 20-300 kDa is absorbed through the stratum corneum, and HA with high molecular weight (1000-1400 kDa) does not penetrate the stratum corneum.The bioavailability of hyaluronic acid depends on its molecular weight. |
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| Half-life | When injected by the intra-articular route hyaluronic acid has a half-life ranging from 17 hours to 1.5 days. The half-life of hyaluronic acid is longer for purified or formulations or preparations with high molecular weight.It can vary according to the molecular weight of the administered HA, according to studies in animals. The metabolic half-life of hyaluronic acid in sheep was determined to be approximately 27 hours in pharmacokinetic studies. In sheep, HA is believed to undergo rapid elimination via the blood and liver. |
| Protein binding | There is limited information in the literature regarding the human pharmacokinetics of hyaluronic acid.In vitro studies determined that serum albumin and hyaluronic acid bind to form a soluble complex. |
| Metabolism | Hyaluronic acid is degraded by a family of enzymes called hyaluronidases.In animals, it is metabolized into oligosaccharides by intestinal bacteria and subsequently reabsorbed in the large intestine. |
| Route of elimination | There is limited information in the literature regarding the human pharmacokinetics of hyaluronic acid.Studies in rats and dogs administered a radio-labeled oral dose of HA showed 87-96% excretion the feces. Excretion of hyaluronic acid is primarily extra-renal, with some contribution from the spleen. |
| Volume of distribution | There is limited information in the literature regarding the human pharmacokinetics of hyaluronic acid.After a dermal filler injection, HA distributes rapidly into the superficial and deep dermis.Hyaluronic acid is distributed to skin of rats after intestinal metabolism into oligosaccharides.In rats and beagle dogs receiving oral hyaluronic acid, HA accumulated in the thyroid gland, kidneys, bladder, and stomach. HA was found to be concentrated in the vertebrae, joints, and salivary glands within 4 hours after a single dose. It is suggested by pharmacokinetic studies in animals that HA distributes into the lymphatic system. |
| Clearance | There is limited information in the literature regarding the human pharmacokinetics of hyaluronic acid.In a pharmacokinetic study of rabbits, maximum clearance capacity of intravenously administered hyaluronic acid was about 30 mg/day/kg. |
Formulation & handling
- Hyaluronic acid is a highly hydrophilic, high‑MW acylaminosugar used primarily in topical, ophthalmic, and intra‑articular formulations where viscosity and rheology control are key design parameters.
- Parenteral and intra‑articular solutions require careful control of molecular weight distribution and endotoxin levels, with sensitivity to shear and pH that can affect viscosity and functional performance.
- Oral and topical products leverage its strong water solubility and gel‑forming properties, with stability largely driven by microbial control rather than chemical degradation.
Regulatory status
| Lifecycle | I don’t have information on the API’s patent expiry timing, so I can’t generate an accurate lifecycle summary. If you provide the patent expiry year (or status), I can draft a concise, neutral 1–2 sentence summary for the US market. |
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| Markets | US |
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Supply Chain
| Supply chain summary | Hyaluronic acid is produced by numerous manufacturers worldwide, as it is a long‑established, non‑patented active ingredient used across therapeutic, dermatologic, and cosmetic products rather than being tied to a single originator. Branded formulations are widely available in the US and globally, reflecting broad commercial uptake rather than region‑specific exclusivity. Patent expiry is not a constraint for this substance, and extensive generic and bulk‑API competition is already established. |
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Safety
| Toxicity | The oral LD50 of the sodium salt of hyaluronic acid is >800 mg/kg in the rat.Overdose information is not readily available in the literature. The safety profile for hyaluronic acid favourable, however, single case reports of death following vaginal injection of hyaluronic acid are published; the deaths likely occurred due to poor procedure regulation. |
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- Oral toxicity is low, with an LD50 ›800 mg/kg (rat) for the sodium salt, indicating a wide acute exposure margin
- Severe adverse outcomes are rare, but isolated reports of fatal events after improper vaginal injections highlight risks associated with uncontrolled procedural use
- Literature notes limited overdose data
Hyaluronic acid is a type of Dermatics
Dermatics is a prominent subcategory within the pharmaceutical Active Pharmaceutical Ingredient (API) sector. It focuses on the development and production of APIs specifically designed for dermatological applications. These APIs play a crucial role in the formulation of various pharmaceutical products used in the treatment of skin disorders, including creams, ointments, gels, and lotions.
Dermatics APIs are meticulously developed to address specific dermatological conditions such as acne, psoriasis, eczema, fungal infections, and other related ailments. The APIs used in these formulations are carefully selected for their therapeutic efficacy, safety, and compatibility with the skin.
Manufacturers of Dermatics APIs employ rigorous quality control measures to ensure the purity, potency, and stability of their products. These APIs undergo extensive testing to meet stringent regulatory standards and pharmacopoeial guidelines. Additionally, the production processes adhere to Good Manufacturing Practices (GMP) to guarantee consistent quality and minimize the risk of contamination.
With the increasing demand for advanced dermatological treatments, Dermatics APIs are subject to continuous research and development. Newer APIs are being explored to enhance efficacy, minimize side effects, and improve patient compliance. The field of Dermatics APIs is characterized by innovation, as researchers strive to develop novel compounds and delivery systems that address unmet therapeutic needs.
In summary, Dermatics APIs are a vital component of pharmaceutical formulations used in the treatment of skin disorders. They undergo stringent quality control measures and are constantly evolving to provide effective and safe dermatological solutions.
Hyaluronic acid (Dermatics), classified under Dermatological Agents
Dermatological agents are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used in the formulation of various skincare and dermatology products. These APIs are specifically designed to target and treat skin conditions, offering effective solutions for a wide range of dermatological concerns.
Dermatological agents encompass a diverse array of compounds, including corticosteroids, antifungal agents, antibacterials, retinoids, and immunomodulators. Each API within this category possesses unique properties and mechanisms of action, enabling them to address specific skin-related issues.
Corticosteroids, for instance, are potent anti-inflammatory agents commonly used in the treatment of skin conditions like eczema, psoriasis, and dermatitis. Antifungal agents, on the other hand, combat fungal infections such as athlete's foot or ringworm. Antibacterials are effective against bacterial infections, while retinoids promote skin cell turnover and treat acne and photoaging. Immunomodulators regulate the immune response, providing relief from conditions like atopic dermatitis.
The development and application of dermatological APIs involve rigorous research, clinical trials, and regulatory compliance. These APIs are typically integrated into topical creams, ointments, gels, and lotions, ensuring targeted delivery to the affected areas of the skin.
Dermatological agents play a crucial role in the management and treatment of various skin disorders. By harnessing the therapeutic properties of these APIs, pharmaceutical companies can develop innovative skincare products that cater to the diverse needs of individuals seeking effective dermatological solutions.
Hyaluronic acid API manufacturers & distributors
Compare qualified Hyaluronic acid API suppliers worldwide. We currently have 9 companies offering Hyaluronic acid 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 |
|---|---|---|---|---|---|
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF | 176 products |
| Blue Eyes Biotech Co., Lt... | Producer | United Kingdom | United Kingdom | CoA | 35 products |
| Fuzhou Medcore Pharmaceut... | Distributor | China | China | CoA, MSDS | 9 products |
| HTL Biotechnology | Producer | France | France | CEP, CoA, FDA, GMP, JDMF, KDMF, MSDS, USDMF | 4 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Pharm Rx Chemical Corp | Distributor | United States | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Shandong Topscience | Producer | China | China | CoA, FDA, GMP, HALAL, ISO14001, ISO9001, KDMF, Kosher, MSDS | 16 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, MSDS, USDMF | 757 products |
| Yantai Dongcheng Bio. | Producer | China | China | CEP, CoA, FDA, GMP, ISO9001 | 10 products |
When sending a request, specify which Hyaluronic acid 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 Hyaluronic acid 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.
