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Lifecore
发布时间:2018-12-13   点击次数:495次

Lifecore

  

 

 

 

 

Lifecore  Pharmaceutical Grade Sodium Hyaluronate

Hyaluronan in Nature

Hyaluronan (also known as sodium hyaluronate or hyaluronic acid) is a polysaccharide composed of repeating disaccharide units of glucuronate and N-acetyl glucosamine (linked by ß 1-3 and ß 1-4 glycosidic bonds) and counter ions. Hyaluronan is a physiological substance that is widely distributed in the extracellular matrix of connective tissues in both animals and humans. It is found in high concentration in the aqueous humor of the eye, synovial fluid, skin, and umbilical cord.

Primary medical applications include: Ophthalmology, Orthopedics, Aesthetics, Tissue Engineering, and Veterinary Medicine

Lifecore's Pharmaceutical Grade Sodium Hyaluronate

Lifecore’s sodium hyaluronate is produced by an efficient microbial fermentation and purified by a highly effective purification process. It is produced in large batches to promote consistency in supply and customer convenience. Pharmaceutical grade sodium hyaluronate is available as a powder in a broad range of molecular weights for use in various medical applications (150KDa – 1.8MDa). Sterile pharmaceutical grade sodium hyaluronate is available in select molecular weights – please inquire.

Why Choose Lifecore for Your Sodium Hyaluronate Needs?

Lifecore Biomedical offers quality, regulatory and technical support, including:

  • Certificate of Suitability (CEP) to the Sodium Hyaluronate Monograph of the European Pharmacopoeia
          - complies with the EU Pharmacopoeia monograph for NaHy
  • Compliance to the Japanese Pharmacopoeia
  • ISO 13485 Certified Quality System
  • ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) compliance
  • CE Mark Certification on Lifecore’s Hyaluronan Based Products
  • Drug and Device Master Files
  • GMP Certification
  • 21 CFR 210, 211, 820, drug and device compliance

 

 

 

Lifecore公司(纳斯达克股票代码:LNDC)的全资子公司Lifecore Biomedical,LLC 致力于开发技术先进的透明质酸产品,与人体长期兼容。自1986年以来,全球有超过5000万名患者受益于Lifecore透明质酸钠产品的创新。

 

Lifecore对质量和服务的承诺确保我们的产品达到或超过美国食品药物管理局,欧洲共同体和其他国际机构制定的蕞高标准。Lifecore设施是ISO 13485和GMP认证,具有质量体系保证和合规性的国际标志。

 

 

  • Lifecore Sodium Hyaluronate

  • Lifecore  Hydrogels

  • Lifecore  Oligosaccharides/Mw Ladders

 

Lifecore’s sodium hyaluronate (NaHy) research materials are derived from pharmaceutical grade batches. NaHy based hydrogels, specialty NaHy oligosaccharides and Mw ladders are available for your research.

 

 

 

  • Lifecore  Design & Development

  • Lifecore  Contract Fermentation

  • Lifecore  Aseptic Filling

  • Lifecore  Our Facility

Lifecore provides manufacturing development for your difficult to fill pharmaceuticals or devices.  We work with you from pre-clinical development through clinical trials to commercial manufacturing of your aseptically filled product.

 

 

 

Lifecore  Clinical Products

 

Lifecore Biomedical manufactures Hyaluronan and other biomaterials into finished products for various medical applications. The products listed below are sold through distribution partners in select countries outside the United States. 

 

What is Lurocoat® Ophthalmic Viscoelastic?

Lurocoat® Ophthalmic Viscoelastic is a single use, sterile, 3% (30mg/mL) solution of highly purified sodium hyaluronate with a viscosity of 50,000 cps, for use in cataract surgery.    

Lurocoat® Ophthalmic Viscoelastic is not available for sale in the United States.

 

 

What is OrtholureTM Orthopedic Viscosupplement?

OrtholureTM Orthopedic Viscosupplement is a single use, sterile, 1% (10mg/mL) solution of highly purified sodium hyaluronate with a mw of 1.2M Daltons.

OrtholureTM Orthopedic Viscosupplement is not available for sale in the United States.

 

 

Utilizing Nature To Improve Lives

Lifecore Biomedical, LLC, a wholly owned subsidiary of Landec Corporation (Nasdaq: LNDC), is dedicated to the development of technically advanced hyaluronan based products that offer long-term compatibility with the human body. Since 1986, more than 50 million patients worldwide have benefited from Lifecore's innovations in sodium hyaluronate products.

 

Lifecore's commitment to quality and service ensures that our products meet or exceed the highest standards set by the United States Food and Drug Administration, the European Community and other international agencies. The Lifecore facility is ISO 13485 and GMP certified, international symbols of quality system assurance and compliance.

上海钰博生物科技有限公司

上海钰博生物科技有限公司

地址:上海市沪闵路6088号龙之梦大厦8楼806室

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