Last updated: April 27, 2026
Who supplies QAMZOVA (voclosporin) and what is known about its manufacturers?
QAMZOVA is the brand name for voclosporin, an oral immunosuppressant. Public supplier and manufacturing details are typically tied to two tracks: (1) drug substance and (2) drug product/labeler. For QAMZOVA, the labeler and the active ingredient are the only supplier data that are consistently disclosed in regulator-facing sources.
What is the labeler/supplier of QAMZOVA?
QAMZOVA labeler (US): Otsuka Pharmaceutical Co., Ltd. (brand owner/label holder).
The US product is marketed under Otsuka’s label, which is the primary “supplier” reference point used in US regulatory labeling and distribution chains.
Who manufactures the drug product (tablets/capsules) for QAMZOVA?
QAMZOVA is marketed in the US as a prescription product with unit dosage forms. The drug product manufacturing site(s) are the critical “supplier” identifiers for R&D sourcing, GMP risk mapping, and contracting.
No complete, regulator-verifiable manufacturing-site list for QAMZOVA is provided in the available information in this prompt.
Who supplies voclosporin (the drug substance)?
Voclosporin is the active pharmaceutical ingredient. Supplier identification for the drug substance (API manufacturer) normally appears in regulator filings and/or packaging insert manufacturing sections.
No complete, regulator-verifiable API supplier list for voclosporin under QAMZOVA is provided in the available information in this prompt.
QAMZOVA supply chain map (what buyers can act on)
Because “supplier” is ambiguous in procurement (labeler vs API vendor vs finished-dose manufacturer), the actionable supply chain view is structured by the three supplier layers used in contracting:
| Supply layer |
What it determines |
Publicly pinned for QAMZOVA from available info |
| Labeler/brand holder |
Distribution rights, product release accountability |
Otsuka Pharmaceutical Co., Ltd. |
| Finished dose (drug product) manufacturer |
Tablet/capsule manufacturing under GMP, release testing chain |
Not provided here |
| API (voclosporin) manufacturer |
Drug substance vendor qualification, DMF/API risk |
Not provided here |
What procurement teams typically request from QAMZOVA suppliers
Even when the labeler is known, buyers usually qualify suppliers through documents aligned with regulatory expectations:
- GMP manufacturing authorization for the finished dose site(s)
- CoA and site-of-manufacture details for each lot
- DMF/ASMF referencing for voclosporin API (or listed cross-reference)
- Change control history impacting voclosporin impurity profile, polymorph/CQA controls, and dissolution specs (where relevant)
Key Takeaways
- QAMZOVA’s labeler/supplier reference point (US): Otsuka Pharmaceutical Co., Ltd.
- Drug product manufacturing sites and voclosporin API supplier identities are not provided in the information available in this prompt, so they cannot be stated as facts here.
- For contracting and supply risk work, procurement should treat labeler as the commercial anchor and then request site-of-manufacture and API vendor documentation through regulatory/QA channels.
FAQs
1) Is Otsuka the supplier of QAMZOVA?
Yes for the labeler/supplier role: QAMZOVA is labeled under Otsuka Pharmaceutical Co., Ltd.
2) Who makes QAMZOVA tablets in GMP terms?
The specific finished-dose manufacturer name(s) and site(s) are not stated in the information provided here.
3) Who supplies the voclosporin API used in QAMZOVA?
The API supplier identity is not provided here.
4) How do I identify the true manufacturing supplier for QAMZOVA lots?
Use lot-specific CoA and the site-of-manufacture listing on packaging/regulatory documents tied to the product.
5) What documents matter most to qualify suppliers for QAMZOVA?
A practical package includes GMP authorization, CoA, and API DMF/ASMF linkage for voclosporin, plus change-control history affecting CQA-related properties.
Sources
[1] Otsuka Pharmaceutical Co., Ltd. QAMZOVA product and labeling information (US prescribing information).
