Shandong Topscience Biotech Co., Ltd. - Sodium Hyaluronate Suppliers DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News, GMP

Topscience Biotech Obtains DMF Reg. Certificate In Korea Again

09 Nov 2024

// PRESS RELEASE

CPHI South East Asia Exhibition I Highlights of Zhongshan Biotechnology

15 Jul 2024

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Zhongshan Biology Shanghai CPHI exhibition is in full swing

24 Jun 2024

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DATA COMPILATION
#PharmaFlow

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Pharma, Lab & Chemical Expo

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DIGITAL CONTENT

1 INTERVIEW #SpeakPharma, 16 CORPORATE CONTENT #SupplierSpotlight, 32 NEWS #PharmaBuzz

media
1 INTERVIEW #SpeakPharma
16 CORPORATE CONTENT #SupplierSpotlight
32 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

6 All APIs, 1 USDMF, 4 CEP/COS, 1 EU WC, 1 KDMF, 1 NDC API, 3 Listed APIs

6 All APIs
1 USDMF
4 CEP/COS
1 EU WC
1 KDMF
1 NDC API
3 Listed APIs

KEY PRODUCTS

Chondroitin Sulfate Sodium, Hyaluronic Acid, Sodium Hyaluronate

Chondroitin Sulfate Sodium
Hyaluronic Acid
Sodium Hyaluronate

Topscience Biotech specializes in R&D, production, and sales of Sodium Hyaluronate, focusing on Medical and Pharmaceutical Grade HA.

About

Established in 2005, Topscience located in Lanshan, Rizhao of PRC and covers an area of 100,000m². Products include Sodium Hyaluronate, Chondroitin Sulfate, Alpha-Arbutin, L-Ascorbic Acid 2-Glucoside, Sulglycotide etc. We have GMP certificate, Drug manufacturing Certificate, CEP of Sodium Hyaluronate, Written Confirmation, Certificate of DMF Registration, Halal, Kosher etc. Sodium Hyaluronate API includes Injection grade, Eye-Drop grade and Excipients grade. The bacterial endotoxin of Sodium Hyaluronate(Injection Grade) is less than 0.001 IU/mg, which is much lower than European Pharmacopoeia current edition 50 times.

DCAT WeekDCAT Week

Industry Trade Show

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17-20 March, 2025

New York, USA
Antibody EngineeringAntibody Engineering

Industry Trade Show

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15-19 December, 2024

Marriott Marquis San Diego
Pharma, Lab & Chemical...Pharma, Lab & Chemical Expo

Industry Trade Show

Not Confirmed

03-05 January, 2025

Chennai, India

CONTACT DETAILS

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Country

China

Address

No.98 Lanshan West Road, Rizhao, Shandong

Telephone

+86 053280821298

sales@topscience.cn

Website

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

https://www.linkedin.com/company/topscience-co-ltd/

YouTube

https://www.youtube.com/@ShandongTopscienceBiotechCoLtd

Digital content

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INTERVIEW #SpeakPharma

“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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