API / Excipients

Sodium Hyaluronate

Japan quality to the world

Microbial fermentation
and non-animal origin

Our sodium hyaluronate is exopolysaccharide fermented from Streptococcus zooepidemicus
which is a kind of lactic acid bacteria.

Sterile grade available

Thanks to our super purification technology, our products are approved by PMDA (Pharmaceuticals and
Medical Devices Agency) as Sterile Pharmaceutical Products in addition to General Pharmaceutical Products.

Support GMP
and world regulations

Our strict quality management system enables us to comply with
GMP control, approved upon PMDA (Pharmaceutical and Medical Device Agency)
and ICH-Q7 (GMP Guide for Active Pharmaceutical Ingredients of ICH)

Regulatory support

Japan : GMP approval [12AZ200052]
Master File [217MF10551]
US : Drug Master File for US FDA [12674]
EU : Certificate of Suitability to the European Pharmacopoeia [R0-CEP 2016-247-Rev 00]
Korea : Drug Master File [20180102-96-E-137-42]
India : API Registration Certificate No. RC/BD-002305

Complied
with Official Standard

Complied with each monograph, an official standard,
of the Japanese, European, British, and Korean Pharmacopoeia.

Japanese Pharmacopoeia Purified Sodium Hyaluronate
European Pharmacopoeia Sodium Hyaluronate
British Pharmacopoeia Sodium Hyaluronate
Korean Pharmacopoeia Sodium Hyaluronate

HALAL Certified

  • Sodium Hyaluronate Pharma Grade 80
  • Sodium Hyaluronate Pharma Grade 150
  • Sodium Hyaluronate FCH-80LE
  • Sodium Hyaluronate GS
    are certified by Japan Muslim Association.

Product lineup

Product Name SODIUM HYALURONATE
GS Pharma Grade 80 Pharma Grade 150 FCH-80LE
Intrinsic Viscosity (m3/kg) 0.39 - 3.31 1.2 - 2.0 2.1 - 2.8 1.18 - 1.95
Average Molecular Weight (Mil.Da) 0.15 - 2.12 0.63 - 1.21 1.28 - 1.86 0.60 - 1.20
Endotoxin (IU/mg) 0.040 0.0025 0.040 0.003
Shelf life 1.5 Years * 3 Years 1 Year 3 Years
Regulatory US DMF ** CEP, US DMF US DMF J-DMF, K-DMF
Indian API Cert
Packaging 100g 10g, 100g 10g, 100g 100g
Sterile / Bioburden Bioburden Bioburden Bioburden Sterile

GQP contract is available within this range.

* : To be reviewed after current long-term stability test is completed. (Max : 3 years)
** : Under processing.

Main Application

Arthritis

Osteoarthritis

Rheumatoid arthritis

Bone regeneration

Viscosupplementation

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Dermal filler

Filling out wrinkles and lines

Lip plumping

Body contouring

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Ophthalmology

Ophthalmic Viscoelastic Device (OVD)

Eye drop

Contact lens solution

Cataract

Intraocular lens

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Others

Skin preparation for external use

Topical skin application

Wound dressing


Medical device coating

Anti - Adhesion

Vesicoureteral and reflux

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  • BROCHURE
  • SDS

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