Last updated: April 26, 2026
Which companies supply MIEBO (perfluorohexyloctane) in the supply chain?
MIEBO is the brand name for perfluorohexyloctane ophthalmic solution. The drug’s commercial supply chain centers on Bausch + Lomb for US commercialization and distribution.
Who is the manufacturer (drug product) for MIEBO?
Bausch + Lomb is the labeled commercial manufacturer for MIEBO in the United States.
| Role |
Company |
What it does |
| Marketing authorization holder / distributor (US) |
Bausch + Lomb |
Commercial distribution of MIEBO ophthalmic solution |
| Drug product manufacturer (as listed in US product labeling) |
Bausch + Lomb |
Produces and/or supplies the finished ophthalmic product as per product labeling |
Source: US label for MIEBO (perfluorohexyloctane ophthalmic solution), which names Bausch + Lomb in the product labeling context for distribution and manufacturing. [1]
Who supplies the active ingredient (API) for MIEBO?
No supplier-by-name for perfluorohexyloctane (API) is provided in the publicly available product labeling for MIEBO. The label identifies the active ingredient (perfluorohexyloctane) but does not name an API manufacturer or named contract API supplier. [1]
Who supplies packaging and finished-dose manufacturing services (CDMO) for MIEBO?
No named contract manufacturing organization (CMO/CDMO) or packaging supplier is identified in the publicly available product labeling for MIEBO. The label provides the commercial manufacturer/distributor name context without listing specific third-party manufacturing and packaging contractors. [1]
What facts matter for procurement and partner screening?
1) The only supplier identification that is explicit in the US label
| Supplier-type item |
Named company in label |
Evidence |
| Finished product distributor/manufacturer (US labeling context) |
Bausch + Lomb |
MIEBO prescribing information identifies Bausch + Lomb in the product labeling context for the marketed product. [1] |
2) What is not named in the label
| Supplier-type item |
Named company in label |
Evidence |
| API manufacturer |
Not named |
Product label names API as perfluorohexyloctane but does not disclose an API supplier. [1] |
| CMO/CDMO for drug product |
Not named |
No third-party manufacturing entity is identified in label. [1] |
| Packaging supplier |
Not named |
No packaging contract entity is disclosed in label. [1] |
How should sourcing decisions be structured for MIEBO-related programs?
Procurement stance
- Treat Bausch + Lomb as the primary contracting and distribution counterpart for MIEBO procurement under US commercial terms. [1]
- For any downstream or programmatic work (relabeling, comparability studies, generic development, or supply diversification), design supplier due diligence around API and manufacturing layers that are not disclosed in the US label. [1]
Due diligence scope (what you must verify in supplier documentation)
- API origin and traceability for perfluorohexyloctane (manufacturer-of-record, CoA, batch genealogy)
- Finished-dose manufacturing-of-record for drug product (site and batch traceability)
- Sterility assurance and container closure system validation for the ophthalmic formulation
- Regulatory documentation alignment with the US marketing application and label claims
These items are necessary because the label does not disclose API, CMO, or packaging suppliers by name. [1]
Key Takeaways
- Bausch + Lomb is the named company in US MIEBO product labeling in the context of commercialization and drug product supply/distribution. [1]
- The public US prescribing information does not name an API supplier for perfluorohexyloctane, nor any named CMO/CDMO or packaging supplier. [1]
- Any supplier diversification or partnership targeting API or manufacturing layers requires verification beyond label-level disclosures.
FAQs
1) Is MIEBO manufactured by Bausch + Lomb?
Yes. The US product labeling identifies Bausch + Lomb in the product context for the marketed ophthalmic drug. [1]
2) Who makes the perfluorohexyloctane active ingredient in MIEBO?
The US MIEBO prescribing information does not disclose a named API manufacturer for perfluorohexyloctane. [1]
3) Are contract manufacturing or packaging suppliers listed on the MIEBO label?
No. The US product labeling does not list specific third-party CMO/CDMO or packaging suppliers by name. [1]
4) Who is the best counterpart to source MIEBO supply for US distribution?
Bausch + Lomb is the explicit company referenced in US labeling for the marketed product. [1]
5) Does the MIEBO label specify manufacturing sites?
The cited public label provides the company context but does not provide a named third-party site list in the supplier sense addressed here. [1]
References
[1] U.S. Food and Drug Administration. MIEBO (perfluorohexyloctane) ophthalmic solution: Prescribing information. FDA label.
