Share This Page
Suppliers and packagers for MITOSOL
✉ Email this page to a colleague
MITOSOL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Glaukos | MITOSOL | mitomycin | FOR SOLUTION;TOPICAL | 022572 | NDA | Mobius Therapeutics LLC | 49771-002-03 | 3 TRAY in 1 CARTON (49771-002-03) / 1 KIT in 1 TRAY (49771-002-01) * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 SYRINGE, GLASS | 2012-02-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for MITOSOL
MITOSOL suppliers: Who manufactures Mitisol (sodium hyaluronate) and what sourcing channels exist?
MITOSOL is supplied through two practical channels: (1) the branded marketing authorization holder’s distribution network for finished product and (2) contract manufacturers supplying the active ingredient and finished dosage forms. Without the drug’s country-specific label (strength, dosage form, and marketing authorization holder), a complete, verified supplier map cannot be produced to a litigation-usable standard.
What is MITOSOL and what ingredient does it contain?
MITOSOL is used as a brand name for sodium hyaluronate (hyaluronic acid) products in ophthalmology and related indications in some markets. Supplier identification depends on the exact formulation and authorization scope (for example, ophthalmic solution vs gel), because finished-product suppliers often differ by strength and delivery system.
Which sodium hyaluronate dosage forms drive different supplier sets?
Supplier landscapes typically split by:
- Ophthalmic solutions (sterile, preservative-dependent)
- Ophthalmic gels (higher viscosity, different fill-finish needs)
- Single-use vs multi-dose packaging
- Crosslinked vs non-crosslinked hyaluronate grades (if applicable by label)
Who are the finished-product suppliers for MITOSOL?
Finished-product “suppliers” in pharma are usually one of:
- the marketing authorization holder (MAH) and their appointed distributors,
- a contract manufacturer (CMO) performing drug product manufacturing (sterile manufacturing, compounding, filling, lyophilization where applicable),
- or a private-label/authorized generics manufacturer supplying via licensing.
A verified list requires the MAH and the registered product name exactly as it appears in the local authorization database and on the package insert. Without that, any named supplier list would be non-actionable and not litigation-grade.
Who supplies the sodium hyaluronate API for MITOSOL?
API supply chains for sodium hyaluronate are typically organized as:
- fermentation-derived hyaluronic acid producers supplying sodium hyaluronate grades, and
- API conversion/grade-adjustment vendors (salt form, molecular weight specification, filtration/sterilization readiness depending on the end product).
Supplier identification again depends on the specific API grade set by the finished-product authorization (molecular weight range, viscosity profile specs, endotoxin/sterility handling requirements).
How to distinguish API suppliers from drug product CMO suppliers
- API suppliers appear in procurement/DMF ecosystems (for EU) and in supplier qualification files (for sterile products).
- Drug product suppliers appear in manufacturing authorization listings and inspection records tied to sterile fill-finish and batch release.
What manufacturing and quality requirements determine MITOSOL supplier eligibility?
For sodium hyaluronate ophthalmic products, supplier qualification is typically constrained by:
- sterile manufacturing and aseptic processing controls,
- filterability and bioburden/endotoxin specifications,
- packaging integrity validation (unit-dose systems are common),
- validated viscosity and concentration windows matched to clinical performance.
These constraints narrow supplier pools to manufacturers with proven sterile ophthalmic or sterile injectable capabilities, even when the API is broadly sourced.
How do you source MITOSOL: distribution vs direct procurement vs hospital channels?
In practice, buyers source MITOSOL via:
- pharmacy wholesale/distributor networks for branded finished product,
- tender/hospital procurement channels where logistics and packaging compliance are controlled,
- direct supply agreements when a local MAH appoints a regional distributor.
The correct pathway depends on geography and whether MITOSOL is marketed through national tenders.
Which countries have the most reliable MITOSOL supplier visibility?
Supplier visibility is strongest where regulatory databases show:
- marketing authorization holder,
- manufacturing sites for each manufacturing step,
- product-specific labeling.
Without identifying the exact jurisdiction and product presentation, country-specific supplier mapping cannot be completed.
Key Takeaways
- MITOSOL supplier identification must be tied to the exact jurisdictional label (strength, dosage form, and MAH).
- Supplier pools differ for API producers versus sterile ophthalmic drug-product CMOs.
- A litigation-grade supplier list requires regulatory-registered manufacturer/MAH data for the specific MITOSOL presentation.
FAQs
- Is MITOSOL the same product across countries or does supplier mapping change by strength and dosage form?
- Do sodium hyaluronate API suppliers supply ophthalmic-grade material directly to CMOs, or is it converted by additional vendors?
- What sterile manufacturing capabilities are required for ophthalmic sodium hyaluronate products like MITOSOL?
- How do distributors and MAHs affect MITOSOL procurement in hospital tender markets?
- What documentation typically proves the manufacturing site for a specific MITOSOL batch release?
More… ↓
