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    Company profile for Shandong Topscience Biotech Co., Ltd

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    speak-pharma/topscience-s-expertise-in-producing-pharma-grade-sodium-hyaluronate-has-made-it-a-leader-in-china

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    Topscience Biotech is a one-stop supplier of sodium hyaluronate//drug manufacturing license, CEP, GMP, DMF, and Form 41 certifications.

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    Topscience Biotechnology, founded in 2005, is a pioneer in sterile sodium hyaluronate raw materials in China, leading industry development through innovation. It offers sodium hyaluronate APIs (injection, eye drop, excipient grades), chondroitin sulfate, and α-arbutin, all with Class A API registration. Using GMP-standard workshops and temperature-controlled logistics, its products feature stability, uniformity, precise molecular weight, and low endotoxin levels. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

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    Shandong Topscience Biotech Co., LtdChina Flag
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    No.98 Lanshan West Road, Rizhao, Shandong
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    +86 53280821298
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    INTERVIEW #SpeakPharma

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    “Topscience’s expertise in producing pharma-grade sodium hyaluronate has made it a leader in China”

    mic“Topscience’s expertise in producing pharma-grade sodium hyaluronate has made it a leader in China”

    This week, SpeakPharma interviews Fu Qiang, Deputy General Manager of Shandong Topscience Biotech, one of China’s leading producers of sterile sodium hyaluronate. Fu discusses the company’s focus on pharmaceutical and high-end applications, the intricacies of aseptic production, and the promising future of the sodium hyaluronate market. 🔑 HIGHLIGHTS// leading producers of sterile sodium hyaluronate/ focus on pharmaceutical and high-end applications China is a major player in the global biotechnology industry. How is Topscience Biotech positioned to compete in this dynamic market? Shandong Topscience Biotech was founded in 2005 and entered the hyaluronic acid industry in 2008. With a history of 16 years in this market, sometimes called a “red ocean” by industry insiders because of the intense competition, Topscience Biotech has carved a distinctive niche for itself within the highly competitive Chinese biotechnology landscape. The sodium hyaluronate market doesn’t have a long development history, nor is it monopolized. There are many “players” in the market. But most of them aren’t technically very strong. They are primarily focused on low-tier applications in food and cosmetics and have no means or ability to achieve high-quality, high-tech products. In contrast, Topscience Biotech has decisively adopted a strategic approach by avoiding the over-competitive, low-end market and focusing on pharmaceutical and high-end application fields with higher technical barriers and fewer competitors. Sodium hyaluronate is currently one of the company’s core products, encompassing food grade, cosmetic grade, medical device grade, and pharmaceutical grade variants. Globally, there are only a handful of companies in the pharmaceutical sector capable of producing pharmaceutical grade sodium hyaluronate, with an even smaller number based in China. We are among the five or six companies competing on the global stage. We have created a competitive barrier by concentrating on the pharmaceutical grade field, which demands higher technical expertise, and by leveraging our aseptic production technology. 🔑 HIGHLIGHTS// avoiding the over-competitive low-end market/ leveraging aseptic production technology/ created a competitive barrier Topscience Biotech is known for its commitment to quality standards. Can you talk about the company's approach to maintaining the highest quality control measures? Topscience Biotech’s reputation for quality is foundational to its success. A crucial aspect of Topscience Biotech’s quality strategy is its mastery of aseptic production technology for pharmaceutical grade sodium hyaluronate, a field in which it is a leading Chinese company. This strategy enables us to avoid price competition and sustain our market dominance. Our approach is in harmony with the national industrial development objectives. It fosters advancements in new quality productivity. We invested significantly in building a robust quality management system that encompasses every stage of the production process, from raw material sourcing and production to final product release. The production of sterile sodium hyaluronate imposes exceptionally high standards on the entire production environment and process flow. Aseptic production, particularly the later purification stages, necessitates stringent control over impurities and endotoxins and demands an exceptionally clean production environment. The construction of the entire system, including personnel, equipment, material management, document control, clean control, and other aspects, is subject to rigorous standards. This is a systematic undertaking. To realize this vision, we engaged a professional organization to design the workshop interior and collaborated with expert manufacturers on research. The resulting system was meticulously designed to optimize the production process. It’s important to note that the investment in this specialized production line far surpasses that of conventional ones. 🔑 HIGHLIGHTS// robust quality management system/ stringent control over impurities and endotoxins Can you elaborate on the specific advantages of STERILEHYA, compared to other sodium hyaluronate products available in the market? The advantage of sterile sodium hyaluronate, such as STERILEHYA, lies not only in the control of the process and aseptic production but also in the fact that it provides new possibilities for product development downstream. Unlike traditional non-sterile sodium hyaluronate, which requires subsequent sterilization, aseptic preparation is the initial step in our production process. Sodium hyaluronate is sensitive to high temperatures, which can cause it to break down. This presents a challenge for those requiring sterile materials. STERILEHYA offers a solution by providing pre-sterilized sodium hyaluronate, eliminating the need for customers to perform their own sterilization processes. This not only saves time but also reduces experimental costs and avoids the risk of degradation during sterilization. STERILEHYA is particularly useful for sterile medicinal products and medical devices that cannot undergo final container sterilization, as it can be incorporated directly into these products without further sterilization steps. This technology has gained widespread recognition in the international market, particularly within ophthalmic surgery and injection applications. As the domestic pharmaceutical industry continues to advance, the demand for sterile sodium hyaluronate, such as STERILEHYA, is steadily increasing within the Chinese market.  🔑 HIGHLIGHTS// new possibilities for product development downstream/ saves time and reduces experimental costs/ ophthalmic surgery and injection applications Biotechnology research is fast-paced. Can you elaborate on Topscience Biotech’s specific strategies for staying ahead of the curve? Topscience Biotech’s core competitiveness stems from its continuous technological innovation, driven by a formidable team of technical experts dedicated to new product development. It has persistently expanded its product line with a spirit of excellence and innovation.  Our R&D team has a deep understanding of the properties of sodium hyaluronate and continuously explores its potential interactions with other chemical substances.  In recent years, we have introduced a series of sodium hyaluronate derivatives to the market, such as sodium acetylated hyaluronate and zinc hydrolyzed hyaluronate, which are now being used by well-known multinational companies Besides this, we have made significant investments in R&D to expand our product line beyond sodium hyaluronate, such as chondroitin sulfate sodium and alpha-arbutin. This diversification demonstrates the company’s commitment to exploring new opportunities within the biotechnology sector. Facing a complex and changing market environment, Topscience Biotech has chosen to stick to its development strategy. We focus on making raw materials, making them refined and specialized, better serving customers, and empowering them to do what they want to do. From food grade to cosmetics grade, medical device grade, pharmaceutical grade, and then to sterile grade, Topscience Biotech’s product line continues to extend to the high-end, confirming the growth logic of “specialized and new” enterprises. The company boasts of a robust R&D team comprising numerous doctors, with over 40 employees holding intermediate professional titles or higher, all committed to innovation. To foster a synergistic research environment, Topscience Biotech has forged strong industry-university-research collaborations with renowned institutions such as Jiangnan University and Shandong University. 🔑 HIGHLIGHTS// formidable team of technical experts/ expand product line beyond sodium hyaluronate What are some of the most exciting opportunities you see for Topscience in the coming years? We maintain a cautiously optimistic outlook on the future of the sodium hyaluronate industry. Opportunities and challenges coexist. While the sector currently faces certain policy and market challenges, the long-term trajectory is promising, driven by increasing market demand and technological advancements. The aging population, with its growing need for orthopedic and ophthalmic care, presents a broad market opportunity for sodium hyaluronate products. Beyond this, the burgeoning medical beauty market offers immense potential for sodium hyaluronate-based products. More and more consumers are beginning to pay attention to the quality and safety of medical beauty products, for which sodium hyaluronate is a critical ingredient. This trend creates significant growth prospects for high-quality raw material suppliers, like Topscience Biotech. Our technological edge and robust supply capacity have positioned us as a preferred partner for numerous medical beauty companies in the high-end market. In today’s uncertain global economy, companies like Topscience Biotech, specializing in niche markets and driving innovation, offer invaluable models for China’s manufacturing sector to emulate.  Topscience Biotech remains an irreplaceable component of the international industrial chain due to its inherent advantages. It is imperative that we optimize our role within this chain to elevate and expand our industry’s influence. We anticipate continued breakthroughs from Topscience Biotech, bringing more surprises and disruption to the pharmaceutical industry. 🔑 HIGHLIGHTS// aging population with growing need for orthopedic and ophthalmic care/ broad market opportunity for sodium hyaluronate products/ burgeoning medical beauty market/ technological edge and robust supply

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    CORPORATE CONTENT #SupplierSpotlight

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    Sodium Hyaluronate Expert

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    STERILEHYA-Sterile Grade Sodium Hyaluronate

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    Medical Device Grade Chondroitin Sulfate Sodium

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    Medical Device Grade PDRN&PN

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    Medical Device Grade Sodium Acetylated Hyaluronate

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    Cross Linked Sodium Hyaluronate

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    COSMEHYA-Cosmetic Grade Sodium Hyaluronate

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    Cosmetic Grade Superfine Sodium Hyaluronate

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    Full Spectrum Sodium Hyaluronate

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    NEWS #PharmaBuzz

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    ARVO 2026 Concludes, Advancing the Future of Eye Health
    ARVO 2026 Concludes, Advancing the Future of Eye Health

    08 May 2026

    // PRESS RELEASE

    https://www.topscience.cn/en/newsInfo1321.html

    PRESS RELEASE
    08 May 2026
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    20 Years of Innovation| Topscience Biotech Drives Biotech Growth
    20 Years of Innovation| Topscience Biotech Drives Biotech Growth

    27 Mar 2026

    // PRESS RELEASE

    https://www.topscience.cn/newsInfo1315.html

    PRESS RELEASE
    27 Mar 2026
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    Topscience Biotech Announces EIA Review for Biochemical Project
    Topscience Biotech Announces EIA Review for Biochemical Project

    02 Feb 2026

    // PRESS RELEASE

    https://www.topscience.cn/newsInfo1311.html

    PRESS RELEASE
    02 Feb 2026
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    Topscience Biotech Launches Medical Device-Grade Hyaluronate
    Topscience Biotech Launches Medical Device-Grade Hyaluronate

    23 Jan 2026

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    http://trongenbio.com/en/newsD.aspx?fid=26&id=103

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    2025 CPHI Frankfurt has successfully concluded!
    2025 CPHI Frankfurt has successfully concluded!

    03 Nov 2025

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    https://www.topscience.cn/en/newsInfo1303.html

    PRESS RELEASE
    03 Nov 2025
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    20 Years: Topscience Sets Sodium Hyaluronate Quality
    20 Years: Topscience Sets Sodium Hyaluronate Quality

    15 Oct 2025

    // PRESS RELEASE

    https://www.topscience.cn/en/newsInfo1298.html

    PRESS RELEASE
    15 Oct 2025
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    ALL APIs

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    01

    Sodium Hyaluronate

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Booth #W3G10
    • fda
    • EDQM
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    Virtual BoothTopscience Biotech is a one-stop supplier of sodium hyaluronate//drug manufacturing license, CEP, GMP, DMF, and Form 41 certifications.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37918

    Submission : 2023-05-05

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-349 - Rev 01

    Issue Date : 2022-03-23

    Type : Chemical

    Substance Number : 1472

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-12-06

    Valid Till : 2025-12-18

    Written Confirmation Number : SD220042

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 84109-001

    Start Marketing Date : 2023-02-01

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Bansen Co., Ltd.

    Registration Date : 2025-10-13

    Registration Number : 20251013-96-E-192-69

    Manufacturer Name : Shandong Topscience Biotech Co., Ltd.

    Manufacturer Address : No.98 Lanshan West Road, Lanshan District, Rizhao City, ShandongProvince, PR China

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    02

    Sodium Hyaluronate

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    Booth #W3G10
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 41832

    Submission : 2025-06-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2022-269 - Rev 00

    Issue Date : 2023-01-19

    Type : Chemical

    Substance Number : 1472

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Bansen Co., Ltd.

    Registration Date : 2025-01-15

    Registration Number : 20250115-96-E-182-63

    Manufacturer Name : Shandong Topscience Biotech Co., Ltd.

    Manufacturer Address : No.98 Lanshan West Road, Lanshan District, Rizhao City, ShandongProvince, PR China

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    Sodium Hyaluronate

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    CPhI China
    Booth #W3G10
    • fda
    • EDQM
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    Virtual BoothTopscience Biotech is a one-stop supplier of sodium hyaluronate//drug manufacturing license, CEP, GMP, DMF, and Form 41 certifications.
    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-348 - Rev 01

    Issue Date : 2022-05-02

    Type : Chemical

    Substance Number : 1472

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Bansen Co., Ltd.

    Registration Date : 2025-01-15

    Registration Number : 20250115-96-E-183-64

    Manufacturer Name : Shandong Topscience Biotech Co., Ltd

    Manufacturer Address : No.98 Lanshan West Road, Lanshan District, Rizhao City, Shandong Province, PR China

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    04

    Sodium Hyaluronate

    China

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    CPhI China
    Booth #W3G10
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothTopscience Biotech is a one-stop supplier of sodium hyaluronate//drug manufacturing license, CEP, GMP, DMF, and Form 41 certifications.
    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-261 - Rev 01

    Issue Date : 2022-05-02

    Type : Chemical

    Substance Number : 1472

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Bansen Co., Ltd.

    Registration Date : 2025-01-15

    Registration Number : 20250115-96-E-184-65

    Manufacturer Name : Shandong Topscience Biotech Co., Ltd.

    Manufacturer Address : No.98 Lanshan West Road, Lanshan District, Rizhao City, ShandongProvince, PR China

     VMF Others AUDIT
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    05

    Chondroitin Sulfate Sodium

    China

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    CPhI China
    Booth #W3G10
    • fda
    • EDQM
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    Virtual BoothTopscience Biotech is a one-stop supplier of sodium hyaluronate//drug manufacturing license, CEP, GMP, DMF, and Form 41 certifications.
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Shandong Topscience Biotech

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    Stock Recap
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    06

    Hyaluronic Acid

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI China
    Booth #W3G10
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothTopscience Biotech is a one-stop supplier of sodium hyaluronate//drug manufacturing license, CEP, GMP, DMF, and Form 41 certifications.
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Shandong Topscience Biotech

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    Stock Recap
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    07

    Sodium DNA

    China

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    CPhI China
    Booth #W3G10
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothTopscience Biotech is a one-stop supplier of sodium hyaluronate//drug manufacturing license, CEP, GMP, DMF, and Form 41 certifications.
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Shandong Topscience Biotech

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Sodium Hyaluronate

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPhI China
    Booth #W3G10
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothTopscience Biotech is a one-stop supplier of sodium hyaluronate//drug manufacturing license, CEP, GMP, DMF, and Form 41 certifications.
    USDMF CEP/COS JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Bansen Co., Ltd.

    Registration Date : 2021-03-16

    Registration Number : 20210316-96-E-168-52

    Manufacturer Name : Shandong Topscience Biotech Co., Ltd.

    Manufacturer Address : No.98 Lanshan West Road, Lanshan District, Rizhao City, ShandongProvince, PR

     VMF Others AUDIT
    Shandong Topscience Biotech

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    09

    Sodium Hyaluronate

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPhI China
    Booth #W3G10
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothTopscience Biotech is a one-stop supplier of sodium hyaluronate//drug manufacturing license, CEP, GMP, DMF, and Form 41 certifications.
    USDMF CEP/COS JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Bansen Co., Ltd.

    Registration Date : 2024-10-23

    Registration Number : 20241023-96-E-181-62

    Manufacturer Name : Shandong Topscience Biotech Co., Ltd.

    Manufacturer Address : No.98 Lanshan West Road, Lanshan District, Rizhao City, Shandong Province, China

     VMF Others AUDIT
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