Last updated: April 25, 2026
Who Supplies ATELVIA (risedronate delayed-release) Materials and Manufacturing?
What is ATELVIA?
ATELVIA is risedronate delayed-release tablets (risedronate sodium), a bisphosphonate product used to treat osteoporosis. The drug uses an enteric-coated, delayed-release formulation intended to reduce gastrointestinal side effects versus immediate-release risedronate.
What company is the marketing authorization holder?
ATELVIA is marketed in the U.S. by Merck Sharp & Dohme LLC (MSD). (FDA label, “Manufactured for” / company listing).
Who manufactures ATELVIA tablets?
ATELVIA is produced under third-party manufacturing and packaging arrangements that are disclosed on the U.S. prescribing information label. The label identifies the manufacturing site(s) and packaged-for details.
Label-disclosed manufacturer / packaging entities (U.S.)
- “Manufactured for” / packaging information is listed on the FDA-approved label for ATELVIA (Merck Sharp & Dohme LLC as the listed marketer; specific site-level manufacturer names are label-dependent by strength and revision).
Because supplier identity can change by strength, label revision, or secondary packaging site, supplier-level names must be taken from the current FDA label revision for the specific strength (e.g., 35 mg once weekly). Without selecting a specific label revision and strength, an exact supplier list cannot be produced accurately.
How do supplier roles typically split for delayed-release oral products?
For a delayed-release oral bisphosphonate tablet like ATELVIA, supplier inputs usually fall into four tiers:
| Tier |
Typical supplier type |
What it provides |
| 1 |
API manufacturer |
Risedronate sodium API |
| 2 |
Excipients / coating suppliers |
Enteric coating polymers, plasticizers, buffering excipients |
| 3 |
Finished-dose manufacturer |
Tablet compression, granulation, coating process, in-process controls |
| 4 |
Packaging line |
Bottle filling, desiccant/closure components, labeling and cartonization |
ATELVIA’s label provides the finished-dose manufacturer(s) and packaging entity(ies), while API and excipient vendor identities are not consistently disclosed at label level.
ATELVIA Supplier Map (What can be stated from the prescribing information)
What supplier facts are directly supported by the ATELVIA label?
The prescribing information states:
- The marketed-for company: Merck Sharp & Dohme LLC (MSD).
- The manufactured-for and/or packaged-for details: the label includes the site/firm responsible for manufacturing and the firm responsible for packaging, which can include third-party manufacturers.
Operational implication for R&D and sourcing
- If you are mapping risk, you should treat label-disclosed “manufactured for/packaged for” firms as the highest-confidence supplier set for clinical and commercial quality supply.
- API and key excipient suppliers usually require linkage from other sources (DMFs, EU manufacturing declarations, or supplier qualification documents), which are not reliably inferable from ATELVIA’s public label alone.
ATELVIA Supplier Sources to Use for Verification (Public, auditable)
Which documents contain the most direct “supplier” identifiers?
| Document |
Where supplier names appear |
Best use |
| FDA Prescribing Information (label) |
“Manufactured for” / packaging statements |
Finished-dose manufacturer and packaging entity |
| FDA Orange Book entry (RLD listing) |
Marketing authorization holder and listing |
Product owner and regulatory entity link |
| FDA Drug Product Manufacturing Information (when available) |
Facility/labeler manufacturing linkage |
Facility-level supply mapping |
For ATELVIA, the label is the primary public artifact that states the manufacturing/packaging firms in plain language.
Key Takeaways
- ATELVIA is risedronate delayed-release marketed by Merck Sharp & Dohme LLC in the U.S. (FDA label).
- The most defensible supplier identifiers are the label-disclosed “manufactured for” and “packaged for” firms; these can vary by strength and label revision, so a complete supplier list must be anchored to the exact current label.
- API and excipient vendor identities are not consistently disclosed at label level, so “supplier” lists should be restricted to the finished-dose manufacturing/packaging entities unless additional regulatory filings are used.
FAQs
1) Who is the company behind ATELVIA in the U.S.?
Merck Sharp & Dohme LLC is listed on the ATELVIA U.S. prescribing information.
2) Does the ATELVIA label list the tablet manufacturer?
Yes. The FDA-approved label includes “manufactured for” and/or packaged for statements that identify the responsible firm(s).
3) Are ATELVIA API supplier and excipient vendors publicly listed on the label?
They are often not listed on the prescribing information for ATELVIA in a way that enables a complete vendor map.
4) Do suppliers change across strengths or label revisions?
They can. Manufacturing and packaging sites are label-version and strength dependent in many branded products.
5) What is the highest-confidence public source for ATELVIA supplier identity?
The ATELVIA FDA prescribing information label for the specific strength and the most current revision.
References
[1] U.S. Food and Drug Administration (FDA). ATELVIA (risedronate sodium) delayed-release tablets, prescribing information (U.S. label), Merck Sharp & Dohme LLC.
