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Hyaluronidase (ovine) | CAS No: 488712-31-8 | GMP-certified suppliers
A medication that enhances absorption and distribution of co‑administered injectable therapies and supports local rehydration across relevant clinical uses.
Therapeutic categories
EnzymesEnzymes and CoenzymesGlycoside Hydrolases
Generic name
Hyaluronidase (ovine)
Molecule type
biotech
CAS number
488712-31-8
DrugBank ID
DB00070
Approval status
Approved drug, Investigational drug
Primary indications
- For increase of absorption and distribution of other injected drugs and for rehydration
Product Snapshot
- Injectable enzyme supplied as lyophilized powder or solution for subcutaneous use
- Used to facilitate absorption and dispersion of co-administered injectables and support rehydration procedures
- Approved in the US with both approved and investigational statuses noted for specific products
Clinical Overview
Hyaluronidase (ovine), CAS 488712-31-8, is a highly purified enzyme preparation derived from sheep sources and administered intravitreally or by other injectable routes. Its primary clinical role is to enhance the absorption and dispersion of co‑administered injectable agents and to support local rehydration by facilitating fluid movement within extracellular matrices. In ophthalmic settings, ovine hyaluronidase has been used to manage vitreous conditions requiring improved tissue permeability; Vitrase has been a notable branded product containing ovine-derived hyaluronidase.
The pharmacologic action relies on catalytic hydrolysis of hyaluronic acid, an essential glycosaminoglycan contributing to the viscosity and structural integrity of connective tissue. By cleaving the glucosaminidic bond between C1 of the glucosamine residue and C4 of glucuronic acid, the enzyme transiently reduces the viscosity of the extracellular matrix. This effect temporarily increases tissue permeability, enabling broader distribution of injected drugs or dispersal of localized exudates and transudates.
Absorption, distribution, metabolism, and elimination data for ovine hyaluronidase are limited due to its protein nature and rapid inactivation in tissues. Activity duration is short, typically confined to the local site of administration, where endogenous inhibitors and proteolytic pathways reduce enzymatic function within hours. Systemic exposure is generally low when used as directed.
Safety considerations include the risk of hypersensitivity reactions, particularly in individuals with a history of allergic responses to animal-derived proteins. Localized adverse effects may include transient edema, irritation, or inflammation at injection sites. Intravitreal use requires adherence to aseptic technique and ophthalmic procedural standards to avoid infection or tissue injury.
For API sourcing, manufacturers should supply characterization data confirming enzymatic activity, purity profile, and absence of adventitious agents associated with ovine materials. Consistent activity units, validated inactivation of potential contaminants, and compliance with regional regulatory expectations are essential for formulation development and quality assurance.
The pharmacologic action relies on catalytic hydrolysis of hyaluronic acid, an essential glycosaminoglycan contributing to the viscosity and structural integrity of connective tissue. By cleaving the glucosaminidic bond between C1 of the glucosamine residue and C4 of glucuronic acid, the enzyme transiently reduces the viscosity of the extracellular matrix. This effect temporarily increases tissue permeability, enabling broader distribution of injected drugs or dispersal of localized exudates and transudates.
Absorption, distribution, metabolism, and elimination data for ovine hyaluronidase are limited due to its protein nature and rapid inactivation in tissues. Activity duration is short, typically confined to the local site of administration, where endogenous inhibitors and proteolytic pathways reduce enzymatic function within hours. Systemic exposure is generally low when used as directed.
Safety considerations include the risk of hypersensitivity reactions, particularly in individuals with a history of allergic responses to animal-derived proteins. Localized adverse effects may include transient edema, irritation, or inflammation at injection sites. Intravitreal use requires adherence to aseptic technique and ophthalmic procedural standards to avoid infection or tissue injury.
For API sourcing, manufacturers should supply characterization data confirming enzymatic activity, purity profile, and absence of adventitious agents associated with ovine materials. Consistent activity units, validated inactivation of potential contaminants, and compliance with regional regulatory expectations are essential for formulation development and quality assurance.
Identification & chemistry
| Generic name | Hyaluronidase (ovine) |
|---|---|
| Molecule type | Biotech |
| CAS | 488712-31-8 |
| UNII | 64R4OHP8T0 |
| DrugBank ID | DB00070 |
Pharmacology
| Summary | Hyaluronidase enzymatically hydrolyzes hyaluronic acid in the extracellular matrix, reducing its viscosity and transiently increasing tissue permeability. By altering hyaluronan structure and influencing related pathways such as TGF‑β1 activity, it enhances the spread and absorption of co‑administered injectable agents. The primary therapeutic intent is to facilitate distribution of injected drugs and fluids. |
|---|---|
| Mechanism of action | Hyaluronidase is a spreading or diffusing substance. It increase the permeability of connective tissue through the hydrolysis of hyaluronic acid. Hyaluronidase hydrolyzes hyaluronic acid by splitting the glucosaminidic bond between C1 of the glucosamine moiety and C4 of glucuronic acid. This temporarily decreases the viscosity of the cellular cement and increases diffusion of injected fluids or of localized transudates or exudates, thus facilitating their absorption. |
| Pharmacodynamics | Hyaluronidase hydrolyzes hyaluronic acid and increase diffusion of injected drugs, thus facilitating their absorption. Hyaluronidase is used for enhancing absorption and distribution of other injected drugs. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Hyaluronan | Humans | other |
| Transforming growth factor beta-1 | Humans | inhibitor |
Formulation & handling
- Hyaluronidase (ovine) is a recombinant/biologic enzyme supplied as both a liquid solution and a lyophilized powder requiring reconstitution for subcutaneous administration.
- Formulations must preserve enzymatic activity; avoid conditions that promote protein denaturation or adsorption to container surfaces.
- Stability is sensitive to temperature and pH variations, so cold‑chain handling and use of compatible diluents are key for maintaining activity.
Regulatory status
| Lifecycle | Patent protections in the US are reaching the end of their term, indicating that the API is moving into a later lifecycle phase. As patents expire, the US market is expected to shift toward greater generic participation and a more mature competitive landscape. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | Hyaluronidase (ovine) is supplied by several US‑based manufacturers that serve as originators and contract producers, with multiple packagers supporting downstream distribution. Branded products such as Vitrase appear to be limited to the US market rather than having broad EU or global presence. Patent protection on these legacy formulations has long expired, indicating existing or ongoing generic and multi‑source competition. |
|---|
Hyaluronidase is a type of Enzyme Replacements/modifiers
Enzyme replacements/modifiers are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) utilized in the treatment of various enzyme-related disorders. Enzymes play a vital role in the normal functioning of the body by catalyzing specific biochemical reactions. However, in certain medical conditions, the body may lack or produce dysfunctional enzymes, leading to serious health complications.
Enzyme replacement therapy (ERT) involves administering exogenous enzymes to compensate for the enzyme deficiency in patients. These enzymes are typically derived from natural sources or produced using recombinant DNA technology. By introducing these enzymes into the body, they can effectively substitute the missing or defective enzymes, thereby restoring normal metabolic processes.
On the other hand, enzyme modifiers are API substances that regulate the activity of specific enzymes within the body. These modifiers can either enhance or inhibit the enzyme's function, depending on the therapeutic objective. By modulating enzyme activity, these APIs can restore the balance of enzymatic reactions, leading to improved physiological outcomes.
Enzyme replacements/modifiers have shown remarkable success in treating various genetic disorders, such as Gaucher disease, Fabry disease, and lysosomal storage disorders. Additionally, they have demonstrated potential in managing enzyme deficiencies associated with rare diseases and certain types of cancer.
The development and production of enzyme replacements/modifiers involve rigorous research, formulation optimization, and adherence to stringent quality control measures. Pharmaceutical companies invest substantial resources in developing these APIs to ensure their safety, efficacy, and compliance with regulatory standards.
Overall, enzyme replacements/modifiers represent a vital therapeutic category in modern medicine, offering hope and improved quality of life for patients with enzyme-related disorders.
Hyaluronidase API manufacturers & distributors
Compare qualified Hyaluronidase API suppliers worldwide. We currently have 3 companies offering Hyaluronidase API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Bbi Enzymes | Producer | South Africa | South Africa | CEP, CoA | 4 products |
| Bioindustria | Producer | Italy | Italy | CEP, CoA, FDA, GMP | 12 products |
| Kraeber & Co GmbH | Producer | Germany | Germany | CoA, GDP, ISO9001, MSDS | 12 products |
When sending a request, specify which Hyaluronidase API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Hyaluronidase API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Hyaluronidase API
Sourcing
What matters most when sourcing GMP-grade Hyaluronidase (ovine)?
Key considerations include confirming US‑appropriate GMP compliance and ensuring the manufacturer has an established track record producing ovine‑derived Hyaluronidase. Supply chain reliability is also important, as several US‑based originators and contract producers supply the API with multiple downstream packagers. Because patent protection has expired and multi‑source competition exists, verifying product specifications and consistency across suppliers is essential.
Which documents are typically required when sourcing Hyaluronidase (ovine) API?
Request the core API documentation set: CoA (3 companies), CEP (2 companies), GMP (1 company), FDA (1 company), ISO9001 (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Hyaluronidase (ovine) API?
Known or reported manufacturers for Hyaluronidase (ovine): Kraeber & Co GmbH. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Hyaluronidase (ovine) API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Hyaluronidase (ovine) manufacturers?
Audit reports may be requested for Hyaluronidase (ovine): 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Hyaluronidase (ovine) API on Pharmaoffer?
Reported supplier count for Hyaluronidase (ovine): 3 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Hyaluronidase (ovine) API?
Production countries reported for Hyaluronidase (ovine): Germany (1 producer), Italy (1 producer), South Africa (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Hyaluronidase (ovine) usually hold?
Common certifications for Hyaluronidase (ovine) suppliers: CoA (3 companies), CEP (2 companies), GMP (1 company), FDA (1 company), ISO9001 (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Hyaluronidase (ovine) (CAS 488712-31-8) used for?
Hyaluronidase (ovine) is used to increase tissue permeability by hydrolyzing hyaluronic acid, which reduces extracellular matrix viscosity. This action enhances the absorption and dispersion of co‑administered injectable drugs and supports local fluid movement. In ophthalmic practice, it has been used intravitreally to improve tissue permeability in vitreous conditions.
Which therapeutic class does Hyaluronidase (ovine) fall into?
Hyaluronidase (ovine) belongs to the following therapeutic categories: Enzymes, Enzymes and Coenzymes, Glycoside Hydrolases. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Hyaluronidase (ovine) mainly prescribed for?
The primary indications for Hyaluronidase (ovine): For increase of absorption and distribution of other injected drugs and for rehydration. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Hyaluronidase (ovine) work?
Hyaluronidase is a spreading or diffusing substance. It increase the permeability of connective tissue through the hydrolysis of hyaluronic acid. Hyaluronidase hydrolyzes hyaluronic acid by splitting the glucosaminidic bond between C1 of the glucosamine moiety and C4 of glucuronic acid. This temporarily decreases the viscosity of the cellular cement and increases diffusion of injected fluids or of localized transudates or exudates, thus facilitating their absorption.
What should someone know about the safety or toxicity profile of Hyaluronidase (ovine)?
Hyaluronidase (ovine) has a generally localized safety profile, with activity limited by rapid inactivation in tissues. Hypersensitivity reactions can occur, especially in individuals with allergies to animal‑derived proteins. Local reactions such as transient edema, irritation, or inflammation may follow injection, and intravitreal use requires strict aseptic technique to reduce the risk of infection or tissue injury. Manufacturers must ensure high purity and absence of adventitious agents to minimize safety concerns.
What are important formulation and handling considerations for Hyaluronidase (ovine) as an API?
Hyaluronidase (ovine) requires formulation conditions that maintain enzymatic activity, whether provided as a liquid or reconstituted from a lyophilized powder for subcutaneous use. It should be protected from temperature and pH excursions, with cold‑chain storage and compatible diluents to prevent loss of activity. Avoiding protein denaturation and adsorption to container surfaces is important during preparation and administration.
Is Hyaluronidase (ovine) a biotech?
Hyaluronidase (ovine) is classified as a biotech. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Hyaluronidase (ovine)?
Yes. As a biologic enzyme, Hyaluronidase is sensitive to temperature and pH variations, and exposure to the acidic gastrointestinal environment would be expected to compromise enzymatic activity. The protein can also denature or adsorb to surfaces, so maintaining suitable conditions is critical. Cold‑chain handling and use of compatible diluents remain important for preserving stability.
Regulatory
Where is Hyaluronidase (ovine) approved or in use globally?
Hyaluronidase (ovine) is reported as approved in the following major regions: US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Hyaluronidase (ovine) right now?
In the United States, Hyaluronidase (ovine) is regulated by the FDA as a drug product, and manufacturers must meet applicable quality, safety, and labeling requirements for enzyme‑based injectable APIs. Products containing ovine‑derived Hyaluronidase have been on the market for many years, and associated product and process patents are generally understood to have expired. As a result, the API is typically considered off‑patent, with regulatory oversight focused on compliance with current FDA standards.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Hyaluronidase (ovine) procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Hyaluronidase (ovine). It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Hyaluronidase (ovine) included in the PRO Data Insights coverage?
PRO Data Insights coverage for Hyaluronidase (ovine): 15 verified transactions across 10 suppliers and 6 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Hyaluronidase (ovine)?
Market report availability for Hyaluronidase (ovine): Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
