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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Kewpie Corporation to the U.S. FDA. Original Data : FDA Website

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    Kewpie is your partner for Sodium Hyaluronate & Hyaluronic Acid// CEP, USDMF, KDMF & JDMF registered.

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    Kewpie first developed Sodium hyaluronate in 1983 and is currently the leading Japanese manufacturer of pharmaceutical grade Sodium hyaluronate used as an API and pharmaceutical excipients. Its Sodium hyaluronate is suitable for injections, eye drops and external preparations. Its pharmaceutical grade Sodium hyaluronate (Hyaluronic acid) is manufactured at its factory near Tokyo under strict regulations. Since 2016, Kewpie has developed and manufactured medical devices using Sodium hyaluronate. Its R&D team can also provide Sodium hyaluronate derivatives as per clients’ needs. Kewpie exports Sodium hyaluronate to over 30 countries.

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    Product List 2023

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    Corporate Presentation

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    Pharmaceutical Ingredients

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    Functional Hyaluronic Acids

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    HYALO-OLIGO

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    Hyabest

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    Hyaloevil-P

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    Hyalorepair

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    New Cross-linked Hyaluronic Acid

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    DATA COMPILATION #PharmaFlow

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    Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination

    Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination

    The pharmaceutical industry has long recognized the critical role excipients or inactive ingredients play in drug formulation and delivery. Excipients can comprise up to 90 percent of a medicine's total ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings. According to recent market research, the pharmaceutical excipients market was valued at US$ 9.27 billion in 2023. It is growing at a compound annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032. The main factors driving market growth is an increased demand for multifunctional excipients, coupled with the expanding use of generic medications. The development in the biologics sector and advancements in nanotechnology are also contributing significantly to market growth. Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination Last year, the World Health Organization (WHO) issued a health alert linking at least 300 child deaths in the Gambia, Uzbekistan, and Indonesia to the ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG). In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards.  Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources. Furthermore, the Indian Health Ministry proposed amendments to the Drugs and Cosmetics Rules, 1945 to include details of excipients on drug labels. While listing all excipients on every strip of medicine may be challenging, the ministry suggested mentioning those causing hypersensitivity on the label. Applicants now mandatorily need to submit evidence of stability and safety of excipients. These regulatory developments have significant implications for excipient manufacturers and pharmaceutical companies worldwide. Leading pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet these heightened quality and safety standards, given their long-standing commitment to producing high-quality, compliant excipients.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market. Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions. The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio.  Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics. Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals. Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities. In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms per gram or less, which is equivalent to 0.1 parts per million (ppm). The company also started full commercial operation of its second manufacturing facility for Ceolus in Japan, enhancing supply capacity and stability. JRS Pharma and Gujarat Microwax opened a state-of-the-art cotton-based croscarmellose sodium plant in Mehsana, Gujarat (India). This facility aims to produce high-quality excipients that meet global standards, potentially reducing India's dependency on imports and boosting its presence in the global excipient market. The Indian excipient industry accounts for less than 1 percent of the global market share.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Seqens to advance innovative polymer; biologics, personalized medicine create demand for specialized excipients Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of polymer development experience, was chosen by Pleryon Therapeutics to advance its leading osteoarthritis candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients.  The rise of biologics and personalized medicine has created a demand for specialized excipients capable of stabilizing complex molecules and enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients. The trend towards patient-centric drug development has also influenced excipient innovation. Excipients that can improve palatability, ease of swallowing, or enable novel dosage forms (such as orally disintegrating tablets) are in high demand. For example, IFF brought a super disintegrant Ac-Di-Sol, that supports faster disintegration and drug dissolution in oral disintegrating tablets, improving patient experience.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Our view The heightened regulatory scrutiny on excipients due to product contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies. Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance. Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.   
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    COMPANY BIO #AboutSupplier

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    View Kewpie's pharmaceutical grade Sodium hyaluronate & browse its different grades of Hyaluronic Acid for injectables & eye drops on PharmaCompass.
    View Kewpie's pharmaceutical grade Sodium hyaluronate & browse its different grades of Hyaluronic Acid for injectables & eye drops on PharmaCompass.
    View Kewpie's pharmaceutical grade Sodium hyaluronate & browse its different grades of Hyaluronic Acid for injectables & eye drops on PharmaCompass.What is Sodium hyaluronate (Hyaluronic acid) and what are its properties?Sodium hyaluronate is the sod...
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    View Kewpie's pharmaceutical grade Sodium hyaluronate & browse its different grades of Hyaluronic Acid for injectables & eye drops on PharmaCompass.

    View Kewpie's pharmaceutical grade Sodium hyaluronate & browse its different grades of Hyaluronic Acid for injectables & eye drops on PharmaCompass.

    View Kewpie's pharmaceutical grade Sodium hyaluronate & browse its different grades of Hyaluronic Acid for injectables & eye drops on PharmaCompass.What is Sodium hyaluronate (Hyaluronic acid) and what are its properties?Sodium hyaluronate is the sodium salt of Hyaluronic acid (HA) which is a mucopolysaccharide made up of glucuronic acid and N-acetylglucosamine. Hyaluronic acid is distributed throughout the body, such as in the human skin (high concentrations are found in the epidermis/dermis), synovial fluid, and the vitreous body of the eyes.Hyaluronic acid is also known by several other names, such as HA, hyaluronan, hyaluronate, and Sodium hyaluronate. The molecular weight of Sodium hyaluronate is lower than the molecular weight of HA. It is, however, small enough to penetrate the epidermis, or top layer of skin, to improve hydration from the underlying skin layers, resulting in a greater hydrating effect.Hyaluronic acid is an elastoviscous fluid composed of hylan polymers, which are derivatives of hyaluronan, a naturally occurring complex sugar. The physiological functions of Hyaluronic acid include anti-aging, wound healing, protection against infection, and collagen fiber biosynthesis.The sources of Hyaluronic acid include bovine tracheas, bovine vitreous, rooster combs, and plants. Industrial production of Hyaluronic acid is based on either its extraction from animal tissues or large-scale lactic acid bacterial fermentation with genetically engineered strains. Plant-based HA is extracted from microbial fermentation in addition to animal-based Hyaluronic acid.A majority of the industries use Hyaluronic acid supplements for joint diseases, particularly inflammation. Sodium hyaluronate is used to alleviate knee pain in patients with osteoarthritis who have not found relief from other treatments. Hyaluronan is found in higher concentrations in synovial tissue and fluid, along with other soft connective tissues. Sodium hyaluronate also plays a key role in cell proliferation, cell migration, matrix assembly, and tissue development, and may also be involved in the advancement of some malignant tumors.Hyaluronic acid comes in five different sizes and molecular weights that permeate various layers of the skin. Because molecules with lower molecular weight are smaller, they can reach deeper layers of the skin. Hyaluronic acid’s molecular weight is significantly dependent on its source; however, refinement of the isolation procedures has resulted in the commercial availability of a wide range of molecular weight grades.The physical properties of Sodium hyaluronate are mentioned below:Purified Sodium hyaluronate is a white powder with no taste or aroma.The molecular weight of the Sodium hyaluronate molecule is around 4,000 to 80,00,000 Daltons.Sodium hyaluronate has high solubility and viscosity.It provides excellent moisture-holding ability and elasticity, as well as a lubricating effect.Sodium hyaluronate is compatible with biological systems.It degrades with heat, enzymes, etc. but can be stabilized by crosslinking.It is stored as a dry powder at 5°C and as a solution at -20°C or lower.Sodium hyaluronate is photosensitive and moisture sensitive, so it should be kept away from light and humidity.Based on its degree of penetration, HA can be classified into high molecular weight Hyaluronic acid (HMW HA) > 18,00,000, middle molecular weight Hyaluronic acid (MMW HA) 10,00,000 - 18,00,000, low molecular weight Hyaluronic acid (LMW HA) 4,00,000 - 10,00,000, small molecular weight Hyaluronic acid: 1,00,000 - 4,00,000 and extra small molecular weight Hyaluronic acid: < 100,000.The high molecular weight Hyaluronic acid moisturizes the surface of the skin, protects the skin’s barrier, and improves its elasticity. It also contains anti-inflammatory properties that can help soothe sensitive or irritated skin. Low molecular weight Hyaluronic acid, on the other hand, can more easily penetrate the skin and is most effective in reducing wrinkles. In addition, topical low molecular weight HA can be used as an alternative to treat facial seborrheic dermatitis.What are the different applications of Sodium hyaluronate in the pharmaceutical and cosmetic industries?Hyaluronic acid is a naturally occurring polysaccharide biopolymer. It is involved in a variety of biological processes including tissue hydration and structural scaffolding. Sodium hyaluronate is increasingly being used as a reagent in pharmaceutical, bioengineering, and medical applications. Exogenous Sodium hyaluronate has been investigated as a drug delivery system for treating cancer, ophthalmology, arthrology, pneumology, rhinology, urology, aesthetic medicine as well as in the cosmetics industry.Sodium hyaluronate is used in numerous pharmaceutical and cosmeceutical applications which include:Drug Delivery Systems: Hyaluronan is biocompatible, viscoelastic, and non-immunogenic. These Sodium hyaluronate characteristics have several medical applications in drug delivery for ophthalmic, nasal, pulmonary, parenteral, and dermal routes.Scaffolds for Tissue Engineering: As a component of the extracellular matrix (ECM), Sodium hyaluronate is responsible for various structural properties of tissues and is involved in cellular signaling. Scaffolds made of Sodium hyaluronate are employed in bone tissue, space-filling, nerve, and brain tissue repair, as well as cell delivery, cell adhesion, and muscle regeneration.Adjuvant to Anticancer Drugs: Medical applications of Hyaluronic acid include its use in the delivery of anticancer drugs because of its superior biocompatibility, biodegradability, and precise targeting of cancer cells.Intra-Articular Injection: Sodium hyaluronate is taken as a supplement alone or in conjunction with collagen, vitamins, chondroitin sulphate, or glucosamine for joint-related problems as well as for the treatment of osteoarthritis. Hyaluronic acid binds efficiently to water, forming a viscous fluid that serves as a lubricant and a shock absorber within the joint. It also helps to increase bone density, mobility, and strength.Ophthalmic Viscosurgical Devices: Ophthalmic grade Sodium hyaluronate is commonly used in viscosurgical devices (OVDs), which are essential in ophthalmic surgeries like cataract extraction, cornea transplantation, glaucoma, intraocular lens (IOL) implantation and vitreoretinal surgery. Sodium hyaluronate is a naturally occurring component of the eye’s vitreous humor and is entirely biocompatible.Eye Moisture Retention: Sodium hyaluronate eye drops can alleviate dry eye symptoms by boosting tear production and stabilizing the corneal surface. Eye drops with high-molecular-weight Hyaluronic acid have anti-inflammatory properties.Wound Healing: In topical preparations, Sodium hyaluronate is used to protect skin ulcers, burns, or wounds from irritation, allowing the skin to heal properly. Hyaluronic acid works to heal wounds by producing the granulation tissue required for wound repair.Skin Benefits of Sodium Hyaluronate: Hyaluronic acid can retain moisture in the extracellular matrix formed in the gaps between cells. Its topical treatment hydrates the skin and keeps it hydrated as a humectant. Sodium hyaluronate is used in anti-aging preparations to help minimize the skin roughness, considerably reduce wrinkle depth and improve skin firmness and elasticity.Dermal Fillers: Hyaluronic acid injections can be used to improve the skin's contour and decrease depressions caused by scars, injuries, or lines. Dermal fillers containing Sodium hyaluronate have been used to treat wrinkles, nasolabial folds, and fine lines around the mouth, lips, cheeks, chin, etc.Furthermore, Hyaluronic acid promotes cell proliferation, cell differentiation, and immunosuppression, and is a component of submucosal injection and resorbable adhesion barriers.In addition, high molecular weight Sodium hyaluronate forms a moisture protecting film at the surface of the skin, helps the skin to hold moisture, inhibits bacterial growth, and reduces UVB-induced apoptosis and inflammation in human epithelial corneal cells. Middle molecular weight Hyaluronic acid helps tighten the skin and keep it moisturized for a long time.Low molecular weight Hyaluronic acid, on the other hand, is smaller, penetrates deeper into the dermis, moderately dilates capillaries, increases blood circulation, and ensures that water is stored in the connective tissue of the skin, making skin firmer and reduces visible wrinkles.How is Kewpie considered a pioneer in the pharmaceutical industry for manufacturing Sodium hyaluronate?Kewpie is a leading Japanese pharmaceutical grade Sodium hyaluronate manufacturer and supplier. It manufactures Hyaluronic acid which is used as an API and a pharmaceutical excipient. It created the first Sodium hyaluronate from chicken comb.Since 1983, Kewpie has been a pioneer Hyaluronic acid manufacturer and supplier. Its R&D team can develop Sodium hyaluronate derivatives to meet the needs of the clients. Kewpie extracts and refines different active ingredients for foods, cosmetics, and pharmaceuticals at its fine chemicals division. It has been developing and manufacturing medical devices using Sodium hyaluronate since 2016.Kewpie is one of the leading Sodium hyaluronate suppliers, exporting Sodium hyaluronate to more than 30 countries. It is a prominent pharmaceutical grade Sodium hyaluronate manufacturer in Japan and can meet the clients’ requirements for tailor-made derivatives. To assure the supply of safe products, Kewpie’s production and quality control (QC) systems are based on Good Manufacturing Practice (GMP). It follows procedures and conducts quality testing at every stage, from receiving raw materials to manufacturing and shipping, and has developed control systems to ensure quality.Kewpie is a leading Sodium hyaluronate producer, offering pharma grade, medical grade, ophthalmic grade, and cosmetic grade Sodium hyaluronate with molecular weights ranging from 800 Da to 35,00,000 Da. It can meet the specific needs of the clients by adjusting the molecular weight. Kewpie not only offers products of biofermentation origin, but it also has natural products, thanks to its advanced extraction and refining technology.Kewpie provides custom-made Sodium hyaluronate derivatives by binding other functional compounds to Sodium hyaluronate, which can acquire new functions and physical characteristics. Kewpie promotes the timely development of products with technical support from R&D experts and regulatory support.Kewpie offers high-quality pharmaceutical grade Sodium hyaluronate. It can produce highly pure and stable products that can maintain the safety and efficacy of the final drug by using its manufacturing knowledge.Kewpie offers ophthalmic grade, pharma grade as well as food, cosmetic and medical grade Sodium hyaluronate. Its Sodium hyaluronate is good for injections, eye drops (ophthalmic solutions), pharmaceuticals, external preparations, and medical formulations.Production of Hyaluronic acid at Kewpie’s facility occurs through two methods - microbial fermentation and extraction from chicken comb. Kewpie has completed several Hyaluronic acid R&D projects since 1983. Kewpie is a leading producer of Hyaluronic acid. It has the technology to control the molecular weight of Sodium hyaluronate to produce it according to customers' needs.Various products developed and offered by Kewpie include Hyabest®(A), Hyabest®(J), Hyabest® (S) LF-P, Hyalo-Oligo®, Hyaloveil®-P, Hyalorepair®, and HAbooster™ which are mentioned in detail below:- Hyabest®(A): It is a low-molecular weight Hyaluronic acid with anti-inflammatory and other properties.- Hyabest®(J): It is an injectable Hyaluronic acid that works on joints.- Hyabest® (S) LF-P: It is an edible version of Hyaluronic acid that is effective against skin damage from ultraviolet radiation. So, it acts as an anti-aging substance.- Hyalo-Oligo®: It has a different moisture retention mechanism from other products. So, it is used in parallel with conventional products.- Hyaloveil®-P: It acts as an adsorbent of Hyaluronic acid for hair and skin and continues to retain moisture.- Hyalorepair®: It is a blend of oil with Hyaluronic acid. It restores the barrier function, preserves skin moisture, and repairs rough skin.- HAbooster™: In addition to the functionality of conventional Hyaluronic acid in retaining skin moisture, it acts to promote collagen metabolization.Kewpie is a pioneer Sodium hyaluronate producer. It produces its products in accordance with Good Manufacturing Practices. It is also one of the leading Sodium hyaluronate suppliers in the world.What are the different grades of Sodium hyaluronate (Hyaluronic acid) offered by Kewpie?Kewpie is a Hyaluronic acid manufacturer and supplier that has been in research for more than 30 years. Kewpie offers safe to use pharma grade, cosmetic grade, food grade, and medical grade Sodium hyaluronate.Pharmaceutical Grade Hyaluronic AcidKewpie is a pharmaceutical grade Sodium hyaluronate manufacturer, which produces various Sodium hyaluronate grades, including injectable grade and ophthalmic grade HA at its manufacturing facility near Tokyo. It is a producer of Hyaluronic acid for eye drops, injections, as well as external preparations.Kewpie manufactures purified Sodium hyaluronate as hyaluronsan HA-AML and hyaluronsan HA-SHL. These are usually used in pharmaceuticals like auxiliary agents for eye surgery and therapeutic agents for osteoarthritis of the knee joint.Kewpie provides various injectable and medical grade Sodium hyaluronate products in powder form, including HA-AML, HA-SHL, HA-AM, and HA-QSE.- Hyaluronsan HA-AML: It is purified Sodium hyaluronate that has an average molecular weight of 500 - 1,200 (kDa) and is obtained via the biofermentation method. It has registered and certified GMP, CEP, and DMF in Japan, the USA, China, and Korea.- Hyaluronsan HA-SHL: It is also a purified Sodium hyaluronate with an average molecular weight of 1,500 - 3,900 (kDa) and is obtained via biofermentation method. It has registered and certified GMP, CEP, and DMF in Japan, the USA, and China.- Hyaluronsan HA-AM: It is obtained via the chicken comb method and has an average molecular weight of 600 - 1,200 (kDa). It has registered and certified GMP and DMF in Japan, the USA, China, and Korea.- Hyaluronsan HA-QSE: It is also obtained via the chicken comb method and has an average molecular weight of 1,900 - 3,900 (kDa). It has registered and certified GMP and DMF in Japan and Korea.Cosmetics Grade Hyaluronic AcidKewpie, a leading producer of Hyaluronic acid, uses Hyaluronic acid products to improve skin problems. Kewpie’s Hyaluronic acid powder series hyaluronsan HA−LQ and hyaluronsan HA−LQH are produced using the microbial fermentation method. These products have higher water and moisture retention qualities and can help in preventing dryness of the skin and hair.Cosmetics Grade Functional Hyaluronic AcidKewpie is a Sodium hyaluronate producer and a leading global functional ingredient Sodium hyaluronate supplier. Kewpie’s functional Hyaluronic acid is not an ordinary humectant. In addition to the high water retention and moisturization qualities that general Hyaluronic acid has, Kewpie adds new functions through its unique technologies.Kewpie’s functional Hyaluronic acids are scientifically proven to cater to client’s specific needs and use. Kewpie’s functional Hyaluronic acids can help in having healthy and vibrant skin. Functional Hyaluronic acids include HAbooster™, Hyalo-Oligo®, Hyaloveil®-P, and Hyalorepair®.- HAbooster™: It is a very low-molecular weight Sodium hyaluronate. It promotes the collagen cycle, increases skin moisture, and improves crow’s feet and nasolabial folds. Its topical application enters the upper layer of the epidermis of the skin and promotes collagen metabolism to improve wrinkles and sagging.- Hyalo-Oligo®: It not only covers the skin’s surface but penetrates deep into the horny layer and contributes moisture to the skin. Conventional Hyaluronic acid remains on the skin's surface and is easy to wash off. However, Kewpie’s Hyalo-Oligo® increases the amount of moisture in the skin twofold. Even after washing the face, the moisture retention capability of Hyaluronic acid remains.- Hyalorepair®: It is an alkylated low-molecular weight Hyaluronic acid that has barrier function recovery with both hydrophobic and hydrophilic aspects for skin care. Its Hyalorepair® suppresses skin’s water evaporation.- Hyaloveil®-P: It is a high molecular weight S